{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-02", "results": { "skip": 0, "limit": 100, "total": 294 } }, "results": [ { "effective_time": "20110826", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers increase drowsiness" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: runny nose and sneezing cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever" ], "set_id": "015d6dbd-d537-4c14-80c3-a7d4ed077fbf", "id": "6038afb7-254e-4b5c-b586-f5833c75c8d3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "dosage_and_administration_table": [ "
adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD and C blue no.1, FD and C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "spl_product_data_elements": [ "Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ALCOHOL CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE SUCROSE SUCRALOSE DOXYLAMINE SUCCINATE DOXYLAMINE" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland" ], "other_safety_information": [ "Other information each 30 mL dose cup contains: sodium 43 mg store at room temperature" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hours adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "Package label Night Time Cold/Flu Relief Original image of bottle label" ], "overdosage": [ "Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20130913", "inactive_ingredient": [ "INACTIVE INGREDIENTS: WATER (AQUA), ALCOHOL (21.6%), SORBITOL, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 10 (CI 47005), GREEN 3 (CI 42053)." ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE. KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "questions": [ "QUESTIONS OR COMMENTS? 1-800-289-8343" ], "spl_product_data_elements": [ "HYVEE ANTISEPTIC BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE D&C YELLOW NO. 10 FD&C GREEN NO. 3" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW." ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE AND PREVENT PLAQUE, GINGIVITIS." ], "set_id": "022f3b76-997a-43c1-b116-52f75bf92a00", "id": "ce7e359e-f064-4874-a5a2-b9782f4b384e", "active_ingredient": [ "ACTIVE INGREDIENTS EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20130605", "inactive_ingredient": [ "Inactive ingredients alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Cough suppressant Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product constipation may occur or be aggravated" ], "spl_product_data_elements": [ "Cheratussin AC codeine phosphate and guaifenesin CODEINE PHOSPHATE CODEINE ANHYDROUS GUAIFENESIN GUAIFENESIN ALCOHOL CARAMEL ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with excessive phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take every 4 hours do not take more than 6 doses in any 24-hour period adults and children 12 years and over take 10 mL (2 tsp) children 6 years to under 12 years take 5 mL (1 tsp) children 2 years to under 6 years consult a doctor children under 2 years do not use Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "spl_unclassified_section": [ "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev. 11/09 R6 8081202 1075" ], "storage_and_handling": [ "Other information store at 15° to 30°C (59° to 86°F) You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811 ." ], "do_not_use": [ "Do not use in a child under 2 years of age if you or your child has a chronic pulmonary disease or shortness of breath if your child is taking other drugs, unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54569-3146-0 Relabeled by: A-S Medication Solutions Libertyville, IL 60048 3146-0.jpg" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive calms the cough control center and relieves coughing" ], "set_id": "0232c4cd-379d-4cf9-ad61-ec3cadaab132", "id": "ec13b5cb-c30f-4a40-b095-fae58eb90fb1", "active_ingredient": [ "Active ingredients (in each 5 mL = 1 tsp) Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 10 mL (2 tsp)
children 6 years to under 12 years take 5 mL (1 tsp)
children 2 years to under 6 years consult a doctor
children under 2 years do not use
" ] }, { "effective_time": "20130111", "inactive_ingredient": [ "Inactive ingredients calcium carbonate, sodium carboxymethyl cellulose, sodium saccharin, sodium lauryl sulfate, flavour, silica, sodium methyl paraben, sodium propyl paraben, CI 16255 Q.S." ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "warning Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "AmerFresh Sodium Monofluorophosphate Sodium Monofluorophosphate Fluoride Ion calcium carbonate carboxymethylcellulose sodium saccharin sodium sodium lauryl sulfate hydrated silica methylparaben sodium propylparaben sodium" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions For Use wet toothbrush and dip into powder until brush is fully covered brush teeth and gum line for at least 30 seconds, rinse and spit out thoroughly Do not swallow supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor. Children under 6 years of age: Do not use unless directed by a doctor or dentist" ], "spl_unclassified_section": [ "Drug Facts", "Exclusive Distributor: AMERCARE Products Inc., Seattle., WA 98165-2226." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 57 g Packet Label AMERFRESH ® FLUORIDE TOOTHPOWDER NET WT. 2 oz (57g) PRINCIPAL DISPLAY PANEL - 57 g Packet Label" ], "indications_and_usage": [ "Use aids in the prevention of dental cavities" ], "set_id": "02ae9422-6c06-4c91-ac42-de7368825e5b", "id": "c4e05d34-45f9-4883-9238-628b1562a55b", "active_ingredient": [ "Active ingredient Sodium monofluorophosphate 0.76% (0.1 w/v fluoride ion)" ] }, { "effective_time": "20151230", "inactive_ingredient": [ "INACTIVE INGREDIENTS: SORBITOL, PURIFIED WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM SACCHARIN, SODIUM BENZOATE, VALERIAN OFFICINALIS RHIZOME/ROOT EXTRACT." ], "keep_out_of_reach_of_children": [ "WARNINGS: KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD." ], "purpose": [ "PURPOSE: ANTICAVITY" ], "warnings": [ "WARNINGS: IF MORE THAN USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "spl_product_data_elements": [ "Go Smile PM SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL WATER HYDRATED SILICA GLYCERIN SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM TITANIUM DIOXIDE SODIUM BENZOATE SACCHARIN SODIUM VALERIAN" ], "openfda": {}, "version": "12", "dosage_and_administration": [ "DIRECTIONS: ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: BRUSH TEETH THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS. INSTRUCT CHILDREN UNDER 6 YEARS OF AGE IN GOOD BRUSHING AND RINSING HABITS (TO MINIMIZE SWALLOWING). SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. CHILDREN UNDER TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR." ], "package_label_principal_display_panel": [ "GO SMiLE PM 1.0 ozTube_V5_7_11 GO SMiLE PM 3.5 ozTube_V4_7_11" ], "indications_and_usage": [ "PURPOSE: ANTICAVITY" ], "set_id": "03eb5f93-d683-4a7c-9946-051a8960804e", "id": "a301581f-f1c8-4739-9992-80d9096e3604", "active_ingredient": [ "ACTIVE INGREDIENTS: SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% W/V FLUORINE ION)" ] }, { "effective_time": "20090827", "drug_interactions": [ "Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction.", "Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.", "Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose.", "Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution.", "Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly." ], "geriatric_use": [ "Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "abuse": [ "Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence." ], "precautions": [ "PRECAUTIONS Animal reproduction studies have not been conducted with the drug combination-promethazine and codeine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine hydrochloride and codeine phosphate should be given to a pregnant woman only if clearly needed. General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers ). Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services). Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine. Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Promethazine was nonmutagenic in the Salmonella test system of Ames. Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown. Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS – General - Ultra-Rapid Metabolizers of Codeine ). Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman. Pediatric Use: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( see WARNINGS – Box Warning and Use In Pediatric Patients ). The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see Warnings-Use in Pediatric Patients ). Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "description": [ "DESCRIPTION Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C 18 H 21 NO 3 •H 3 PO 4 •½H 2 O, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and the following structural formula: This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine.", "Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C 18 H 21 NO 3 •H 3 PO 4 •½H 2 O, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and the following structural formula: This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine." ], "labor_and_delivery": [ "Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown." ], "general_precautions": [ "General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers ).", "Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers )." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP." ], "indications_and_usage": [ "INDICATIONS AND USAGE Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold." ], "dependence": [ "Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "set_id": "0505fe62-ac59-475e-8c94-1933398be580", "id": "30004e84-7a7b-46ac-b6fe-bd1835dd9fcf", "teratogenic_effects": [ "Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.", "Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known.", "Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." ], "pediatric_use": [ "Use In Pediatric Patients The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. The association does not directly relate to individualized weight-based dosing, which might otherwise permit safe administration. Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.", "Pediatric Use: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( see WARNINGS – Box Warning and Use In Pediatric Patients ). The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see Warnings-Use in Pediatric Patients )." ], "inactive_ingredient": [ "Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose." ], "contraindications": [ "CONTRAINDICATIONS The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. Codeine is contraindicated in patients with a known hypersensitivity to the drug. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance. Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence. Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "warnings": [ "WARNINGS WARNING: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. Codeine: Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients. Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ). Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Codeine: Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.", "Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function.", "Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ). Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ).", "Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.", "Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.", "Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents.", "Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Other Considerations Administration of promethazine has been associated with reported cholestatic jaundice." ], "pregnancy": [ "Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "nursing_mothers": [ "Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS – General - Ultra-Rapid Metabolizers of Codeine ). Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman." ], "spl_product_data_elements": [ "Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate CODEINE PHOSPHATE CODEINE PROMETHAZINE HYDROCHLORIDE PROMETHAZINE ALCOHOL ASCORBIC ACID CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 3 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE grape blend flavor" ], "boxed_warning": [ "WARNING: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients." ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine.", "Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.", "Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine." ], "openfda": {}, "controlled_substance": [ "Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance." ], "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. It is important that promethazine with codeine syrup is measured with an accurate measuring device (see PRECAUTIONS-Information For Patients ). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. The average effective dose for adults and children 12 years of age and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours. The average effective dose for children 6 years to under 12 years of age is 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours." ], "adverse_reactions": [ "ADVERSE REACTIONS Codeine: Nervous System – CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions. Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics). Gastrointestinal – Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported. Genitourinary – Oliguria, urinary retention; antidiuretic effect has been reported (common to narcotic analgesics). Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema. Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness. Promethazine: Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported. Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic – Dermatitis, photosensitivity, urticaria. Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Gastrointestinal – Dry mouth, nausea, vomiting, jaundice. Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS - Promethazine; Respiratory Depression .) Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS - Promethazine; Neuroleptic Malignant Syndrome .) Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCI. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients." ], "spl_unclassified_section": [ "CV Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181652 R1/09-R4 Relabeling of \"Additional Barcode label\" by: Physicians Total Care, Inc. Tulsa, OK 74146" ], "how_supplied": [ "HOW SUPPLIED Promethazine with Codeine Syrup, a clear purple syrup with odor of grape menthol, contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent, and is available in: 4 fluid ounce (118 mL) NDC 54868-1029-1 , 8 fluid ounce (237 mL) NDC 54868-1029-0 . and pint (473 mL) NDC 54868-1029-2 ." ], "information_for_patients": [ "Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Promethazine with Codeine Syrup This is an image of the label for Promethazine with Codiene Syrup." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours. Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.", "Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours.", "Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Promethazine was nonmutagenic in the Salmonella test system of Ames." ], "nonteratogenic_effects": [ "Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "overdosage": [ "OVERDOSAGE Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates. Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur. Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful.", "Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates.", "Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur.", "Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful." ] }, { "effective_time": "20110510", "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water." ], "purpose": [ "Purpose of Brompheniramine maleate: Antihistamine Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant Purpose of Dextromethorphan hydrobromide: Cough Suppressant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use in children under 6 years of age Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, emphysema, or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsines be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use more than directed marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsines be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions Made in USA for Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811" ], "spl_product_data_elements": [ "Q-Tapp DM Elixir Brompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide Brompheniramine maleate Brompheniramine Pseudoephedrine hydrochloride Pseudoephedrine Dextromethorphan hydrobromide Dextromethorphan anhydrous citric acid FD&C blue no. 1 FD&C red no. 40 glycerin propylene glycol saccharin sodium sodium benzoate sodium citrate sorbitol water grape flavor" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, emphysema, or chronic bronchitis" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than 4 doses in any 24-hour Adults and children 12 years and over 20 mL (4 tsp) every 4 to 6 hours Children 6 years to under 12 years 10 mL (2 tsp) every 4 to 6 hours Children under 6 years DO NOT USE Other information each tsp contains: sodium 2 mg Store at room temperature 20°-25°C (68°-77°F)." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "container label" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis temporarily relieves symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose" ], "set_id": "0654b093-2067-492f-a0bc-647dac430bde", "id": "6c130ae2-6aca-4264-95e3-dc820abb311c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active Ingredient: Brompheniramine maleate 1 mg (in each 5 mL = 1 tsp) Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL = 1 tsp) Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL = 1 tsp)" ], "dosage_and_administration_table": [ "
Adults and children 12 years and over 20 mL (4 tsp) every 4 to 6 hours
Children 6 years to under 12 years 10 mL (2 tsp) every 4 to 6 hours
Children under 6 years DO NOT USE
" ] }, { "effective_time": "20140314", "inactive_ingredient": [ "Inactive ingredients Water, Alcohol (15%), Sorbitol Solution, Poloxamer 407, Benzoic Acid, Flavour, Sodium Saccharin, Sodium Citrate, Citric Acid, FD&C Yellow No.6, FD&C Red No. 40." ], "purpose": [ "Purpose Antiplaque/Antigingivitis" ], "keep_out_of_reach_of_children": [ "Keep out of reach of childre n. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not swallow Not to be used by children under 12 years of age" ], "spl_product_data_elements": [ "Oral Dent Citrus Eucalyptol, Thymol, Methyl Salicylate, Menthol EUCALYPTOL EUCALYPTOL THYMOL THYMOL METHYL SALICYLATE SALICYLIC ACID MENTHOL MENTHOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM CITRATE CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 FD&C RED NO. 40" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Rinse Full Strength with 2/3 ounce (20 ml) for 30 seconds twice a day to help kill germs that cause bad breath, plaque and gingivitis." ], "spl_unclassified_section": [ "Other information Cold temperature may cloud this product; its efficacy will not be affected. Store at room temperature (59 0 -86 0 F) Do not use if security band around cap is missing or broken", "Manufactured for International Cosmetics Ltd. ICL Drive, Bhagowtie Trace, San Juan, Trinidad & Tobago, W.I. INFO. CALL:1-868-675-2674" ], "package_label_principal_display_panel": [ "Packaging Oral dent carton" ], "indications_and_usage": [ "Uses Helps kill germs that cause plaque, gingivitis and bad breath." ], "set_id": "084088c9-e7d6-48ea-bed9-6b4cd54141dc", "id": "2faeb6db-8f12-448e-b7ad-19b86f506192", "active_ingredient": [ "Active ingredients (W/V) Eucalyptol 0.092% Thymol 0.064% Methyl Salicylate 0.060% Menthol 0.042%" ] }, { "effective_time": "20131217", "inactive_ingredient": [ "Inactive ingredients Ginger Lime flavor, glycerin, purified water, saccharin sodium, sodium benzoate" ], "purpose": [ "Purpose Saline laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Dosage warning Taking more than the recommended dose in 24 hours can be harmful. Do not use • if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities • in children under 5 years of age • for bowel cleansing Ask a doctor before use if you have • abdominal pain, nausea, or vomiting • kidney disease • heart problems • a sudden change in bowel habits lasting more than 2 weeks • already used a laxative for more than a week • a dehydration condition Ask a doctor or pharmacist before use if you are • on a sodium restricted diet • under a doctor’s care for any medical condition • taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. Stop use and ask a doctor if you • have any rectal bleeding • do not have a bowel movement within 6 hours • have any symptoms that your body is losing more fluid than you are drinking • have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting. These symptoms may indicate a serious condition. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "questions": [ "Questions 1-800-633-5463" ], "spl_product_data_elements": [ "Oral Saline Laxative dibasic sodium phosphate, monobasic sodium phosphate SODIUM PHOSPHATE, DIBASIC PHOSPHATE ION SODIUM PHOSPHATE, MONOBASIC PHOSPHATE ION GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE" ], "ask_doctor": [ "Ask a doctor before use if you have • abdominal pain, nausea, or vomiting • kidney disease • heart problems • a sudden change in bowel habits lasting more than 2 weeks • already used a laxative for more than a week • a dehydration condition" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • use as a laxative for relief of occasional constipation • dilute dose in the table below with one glass (8 fl. oz.) cool water. Drink, then follow with at least one additional glass (8 fl. oz.) cool water. There is significant loss of liquid when using this product. To prevent dehydration drink plenty of clear liquid after use. • Do not use for bowel cleansing. • Do not take more unless directed by a doctor. See Warning. There are three Teaspoons in one Tablespoon. Ages (Years) Dosage Maximum Dose 12 & Older 3 Teaspoons 6 or 9 Teaspoons* 10 & 11 3 Teaspoons* 3 Teaspoons* 5 to 9 1 1/2 Teaspoons* 1 1/2 Teaspoons* under 5 Do Not Use Do Not Use *SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you • have any rectal bleeding • do not have a bowel movement within 6 hours • have any symptoms that your body is losing more fluid than you are drinking • have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting. These symptoms may indicate a serious condition." ], "storage_and_handling": [ "Other information • Each Teaspoon contains: sodium 556 mg • Saline laxatives increase retention of water in the intestine, promoting bowel movements. • this product generally produces a bowel movement in 30 minutes to 6 hours • this product is sugar free • do not freeze • store at room temperature TAMPER EVIDENT: Mouth of bottle sealed for your safety. If foil seal is missing or broken, do not use." ], "do_not_use": [ "Do not use • if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities • in children under 5 years of age • for bowel cleansing" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel NDC 0363-0126-12 Well at Walgreens SUGAR FREE SINGLE DOSE Oral Saline Laxative Phosphate • For relief of occasional constipation Sugare Free 1.5 fl oz (45 mL) GINGER LIME FLAVOR Walgreens Phosphate Oral Saline Laxative principal display panel", "Drug Facts 1 Walgreens Oral Saline Drug Facts 1", "Drug Facts 2 Walgreens Oral Saline Drug Facts 2" ], "indications_and_usage": [ "Use • for relief of occasional constipation" ], "set_id": "086fba92-75d0-4c2b-abcd-72ba10b86574", "id": "086fba92-75d0-4c2b-abcd-72ba10b86574", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are • on a sodium restricted diet • under a doctor’s care for any medical condition • taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient (in each tablespoon) Dibasic sodium phosphate .9 g Monobasic sodium phosphate 2.4 g" ], "dosage_and_administration_table": [ "
Ages (Years) Dosage Maximum Dose
12 & Older 3 Teaspoons 6 or 9 Teaspoons*
10 & 11 3 Teaspoons* 3 Teaspoons*
5 to 9 1 1/2 Teaspoons* 1 1/2 Teaspoons*
under 5 Do Not Use Do Not Use
" ] }, { "effective_time": "20110209", "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water." ], "purpose": [ "Purpose: Fever reducer/pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away, (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Sore throat warning : if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "when_using": [ "When using this product do not exceed recommended dosage. (see overdose warning)" ], "questions": [ "Comments 1-888-974-5279 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West St. Spring Valley , NY 10977 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320" ], "spl_product_data_elements": [ "Infants Silapap Acetaminophen Acetaminophen Acetaminophen anhydrous citric acid FD&C yellow no. 6 methylparaben saccharin sodium sodium benzoate sodium citrate propylene glycol water wild cherry" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ■ this product does not contain directions or complete warnings for adult use ■ do not give more than directed (see overdose warning) ■ find right dose on chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■ dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■ If needed, repeat dose every 4 hours ■ do not give more than 5 times in 24 hours ■ Replace dropper tightly to maintain child resistance Weight (lb) Age (yr) Dose (mL) under 24 under 2 years ask a doctor 24-35 2-3 years 1.6 mL (0.8 + 0.8 mL) For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb. Other information Store between 20° - 25°C (68° - 77°F)" ], "stop_use": [ "Stop use and ask a doctor if ■ new symptoms occur ■ redness or swelling is present ■ pain gets worse or lasts for more than 5 days ■ fever gets worse or lasts for more than 3 days. These could be signs of serious condition." ], "do_not_use": [ "Do not use with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin." ], "package_label_principal_display_panel": [ "Acetaminophen 80mg/0.8ml" ], "indications_and_usage": [ "Uses temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■the common cold ■flu ■toothaches ■sore throat ■headaches" ], "set_id": "0924758b-9d8c-490a-a8b3-56b5aee12962", "id": "0924758b-9d8c-490a-a8b3-56b5aee12962", "active_ingredient": [ "Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (mL)
under 24 under 2 years ask a doctor
24-35 2-3 years 1.6 mL (0.8 + 0.8 mL)
" ] }, { "effective_time": "20151111", "inactive_ingredient": [ "Inactive Ingredients Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring" ], "purpose": [ "Purpose Antihistamine Antitussive (cough suppressant) Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not use to sedate a child or make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug.", "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus)", "Ask a doctor or pharmacist before use if you are taking any other nasal decongestant or stimulant taking sedatives or tranquilizers", "When using this product Do not exceed recommended dosage. marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.", "If pregnant or breast-feeding, ask a health professional before use." ], "questions": [ "Questions or Comments Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com ." ], "spl_product_data_elements": [ "LoHist PEB DM Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride BENZOIC ACID EDETATE DISODIUM FD&C RED NO. 40 PROPYLENE GLYCOL WATER SACCHARIN SODIUM SORBITOL BROMPHENIRAMINE MALEATE BROMPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions do not exceed 6 doses in a 24-hour period Age Dose Adults and children over 12 years of age 1 teaspoonsful (5 mL) every 4 hours Children 6 to under 12 years of age 1/2 teaspoonsful (2.5 mL) every 4 hours Children under 6 years of age Ask your doctor" ], "spl_unclassified_section": [ "Drug Facts", "Other Information store at 20°-25°C (68°-77°F) very low sodium, contains 1 mg sodium per teaspoonful (5 mL)" ], "package_label_principal_display_panel": [ "Principal Display Panel Figure 1: 16 oz Bottle Label LoHist PEB-DM label" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis): cough due to minor throat and bronchial irritation runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily restores freer breathing through the nose" ], "set_id": "09cc3f76-e7fe-4245-bd2e-8de393ccb4dd", "id": "24468a68-7f52-32fc-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients In each 5 mL (1 teaspoonful) Brompheniramine Maleate, USP 4 mg Dextromethorphan HBr, USP 20 mg Phenylephrine HCl, USP 10 mg" ], "dosage_and_administration_table": [ "
Age Dose
Adults and children over 12 years of age 1 teaspoonsful (5 mL) every 4 hours
Children 6 to under 12 years of age 1/2 teaspoonsful (2.5 mL) every 4 hours
Children under 6 years of age Ask your doctor
" ] }, { "effective_time": "20100607", "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive Ingredient: Purified water.", "Inactive ingredients flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose" ], "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Use: For preparation of skin before injection.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporary relief of minor aches, pains and headaches to reduce fever associated with colds, sore throats, teething" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only.", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product." ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Wipe Injection site vigorously and discard." ], "spl_product_data_elements": [ "ARC FIRST AID Contains 404 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Chewable Aspirin ASPIRIN ASPIRIN ASPIRIN FD&C YELLOW NO. 6 SACCHARIN SODIUM CATION SILICON DIOXIDE STARCH, CORN STEARIC ACID SUCROSE ORANGE ASPIRIN Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B" ], "description": [ "LOT/EXP: Made in CHINA 20130301", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "LOT/EXP: Made in CHINA 20140301", "Made in CHINA LOT/EXP:", "MADE IN USA Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "ask_doctor": [ "Ask a doctor before use if you have; asthma stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems a child experiencing arthritis pain if you are; allergic to aspirin taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions Do not use more than directed Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours, Do not exceed 48 tablets in 24 hours unless directed by a doctor. Children Under 12 years: Consult a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and ask a doctor if; an allergic reaction occurs, Seek medical help right away pain or fever persists new or unexpected symptoms occur redness or swelling is present ringing in ears or loss of hearing occurs" ], "storage_and_handling": [ "Other Information: Store at room temperature", "Other information: Store at room temperature.", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Flammable - keep away from fire or flame.", "Store at room temperature tamper evident sealed packets do not use any opened or torn packets" ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: with electrocautery, in the eyes.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you are allergic to aspirin or any other pain relievers/fever reducers for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor for at least 7 days after a tonsillectomy or oral surgery" ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Antiseptic Towelette", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "GenuineTripleAntibiotic", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "GenuineEyeWash", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AlcoholCleansingPad", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "2 Tablets GENUINE FIRST AID. Chewable Aspirin 81mg", "Chewable Aspirin 81mg", "American Red Cross CONTAINS 404PIECES FIRST AID KIT CLEAN . TREAT . PROTECT HOME PLAY AUTO OFFICE WORK All Purpose Kit NEW ORGANIZED POCKETS FOR EMERGENCY ACCESS SMALL CUTS AND BURNS 1 MEDIUM CUTS AND SCRATCHES 2 SEVERE BLEEDING AND BURNS 3 CAP BREATHING BARRIER 4 PROTECTION 5 INSTRUMENTS 6 AND EASY REFILL SYSTEM REFILL PACKS AVAILABLE FOR EACH POCKET Carrying Case 1 Soft-side Bag 1 Easy Access Pocket System Small Cuts and Burns 25 Adhesive Plastic Bandages 3/4\"x3\" 235 Junior Plastic Bandages 3/8\"x1-1/2\" 8 Adhesive Plastic Bandages 1\"x3\" 2 Knuckle Fabric Bandage 50 Adhesive Spot Bandages 7/8\"x7/8\" 2 Fingertip Fabric Bandage 2 Elbow/Knee Adhesive Bandage 1 Burn Cream 5 Antiseptic Towelettes 1 Triple Antibiotic Ointment 0.9gr 2 Sterile Gauge Pads 2\"x2\" 10 Cotton Tipped Applicators Medium Cuts and Scratches 5 Antiseptic Towelettes 2 Sterile Gauge Pad 2\"x2\" 2 Sterile Gauge Pad 3\"x3\" 2 Sterile Gauge Pad 4\"x4\" 1 Roller Gauge Bandage 3\"x4.1yds. 2 Sterile Eye Pads 1 Sterile Eye Wash 10ml 4 Butterfly Wound Closures Severe Bleeding and Burns 1 First Aid Tape Roll 1/2\"x2.5 yds. 1 Combine Pad 5\"x9\" 1 Combine Pad 8\"x10\" 1 Roller Gauge Bandage 3\"x4.1yds. CPR 1 CPR Breathing Barrier Protection 2 Medical Grade Vinyl Gloves 1 Instant Cold Compress 4 Alcohol Cleansing Pads 1 Insect Sting Relief Pads 1 Emergency Blanket 38\"x60\" 4 Chewable Aspirin Tablets 1 Triangular Bandage 42\"x42\"x59\" Instruments 1 Emergency First Aid Guide 1 Plastic Tweezers 1 Scissors 6 Assorted Safety Pins 2 Wooden Finger Splints Copyright 2009 Genuine First Aid LLC. All rights reserved. Manufactured in China for: Genuine First Aid LLC. 600 Cleveland Street Suite 400 Clearwater FL 33755 www.GenuineFirstAid.com GENUINE FIRST AID", "ARC First Aid Kit 404" ], "set_id": "0af5dc2e-09ce-4bc9-911f-ec2fd8f1e426", "id": "6abbad39-121a-4516-86f7-44bff245d21b", "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID*). . . . . . . . . . . . . Analgesic/Antipyretic *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20130513", "inactive_ingredient": [ "INACTIVE INGREDIENTS: WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 10 (CI 47005), GREEN 3 (CI 42053)." ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)." ], "warnings": [ "WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE. KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)." ], "questions": [ "QUESTIONS OR COMMENTS? 1-800-842-7886" ], "spl_product_data_elements": [ "SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE D&C YELLOW NO. 10 FD&C GREEN NO. 3" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW." ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS." ], "set_id": "0c3ee0f2-6637-42fd-9f72-01ec4de3c7ba", "id": "949dd636-d8ba-4a5b-ae1e-3ccec300cd7b", "active_ingredient": [ "ACTIVE INGREDIENT EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20100607", "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive Ingredient: Purified water.", "Inactive ingredients flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose" ], "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Use: For preparation of skin before injection.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporary relief of minor aches, pains and headaches to reduce fever associated with colds, sore throats, teething" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only.", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product." ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Wipe Injection site vigorously and discard." ], "spl_product_data_elements": [ "FIRST AID Contains 404 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOTROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Chewable Aspirin ASPIRIN ASPIRIN ASPIRIN FD&C YELLOW NO. 6 SACCHARIN SODIUM CATION SILICON DIOXIDE STARCH, CORN STEARIC ACID SUCROSE ORANGE ASPIRIN Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B" ], "description": [ "LOT/EXP: Made in CHINA 20130301", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "LOT/EXP: Made in CHINA 20140301", "Made in CHINA LOT/EXP:", "MADE IN USA Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "ask_doctor": [ "Ask a doctor before use if you have; asthma stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems a child experiencing arthritis pain if you are; allergic to aspirin taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions Do not use more than directed Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours, Do not exceed 48 tablets in 24 hours unless directed by a doctor. Children Under 12 years: Consult a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and ask a doctor if; an allergic reaction occurs, Seek medical help right away pain or fever persists new or unexpected symptoms occur redness or swelling is present ringing in ears or loss of hearing occurs" ], "storage_and_handling": [ "Other Information: Store at room temperature", "Other information: Store at room temperature.", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Flammable - keep away from fire or flame.", "Store at room temperature tamper evident sealed packets do not use any opened or torn packets" ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: with electrocautery, in the eyes.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you are allergic to aspirin or any other pain relievers/fever reducers for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor for at least 7 days after a tonsillectomy or oral surgery" ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Antiseptic Towelette", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "GenuineTripleAntibiotic", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "GenuineEyeWash", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AlcoholCleansingPad", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "2 Tablets GENUINE FIRST AID. Chewable Aspirin 81mg", "Chewable Aspirin 81mg", "GENUINE FIRST AID. CONTAINS 404 PIECES FIRST AID KIT CLEAN . TREAT . PROTECT with 6 First Aid Pockets 1 Small Cuts and Burns 2 Medium Cuts and Scratches 3 Severe Bleeding and Burns 4 CPR 5 Protection 6 Instruments New REFILL PACKS AVAILABLE FOR EACH POCKET HOME PLAY AUTO OFFICE WORK All Purpose Kit Soft-Sided Storage Case With Pockets that are Organized for Quick and Easy Emergency Access Carrying Case 1 Soft-side Bag 1 Easy Access Pocket System POCKET 1: SMALL CUTS AND BURNS 25 Adhesive Plastic Bandages 3/4\"x3\" 235 Junior Plastic Bandages 3/8\"x1-1/2\" 8 Adhesive Plastic Bandages 1\"x3\" 2 Knuckle Fabric Bandages 50 Adhesive Spot Bandages 7/8\"x7/8\" 2 Fingertip Fabric Bandages 2 Elbow/Knee Adhesive Bandage 1 Burn Cream 5 Antiseptic Towelettes 1 Triple Antibiotic Ointment 0.5gr 1 Sterile Gauge Pad 2\"x2\" 20 Cotton Tipped Applicators POCKET 2: MEDIUM CUTS AND SCRATCHES 5 Antiseptic Towelettes 1 Sterile Gauze Pad 2\"X2\" 2 Pressure Bandages 2\"X2\" 2 Pressure Bandage 3\"X3\" 1 Sterile Eye Pad 1 Sterile Eye Wash 10ml 1 Butterfly Wound Closures POCKET 3: SEVERE BLEEDING AND BURNS 1 First Aid Tape Roll 1/2\"x 2.5yds 1 Bloodstopper Dressing POCKET 4: CPR 1 CPR Breathing Barrier POCKET 5: PROTECTION 2 Medical Grade Gloves 1 Instant Cold Compress 14 Alcohol Cleansing Pads 1 Insect Sting Relief Pad 1 Emergency Blanket 38\"X 60\" 2 Chewable Aspirin Tablets 1 Triangular Bandage 42\"x42\"x59\" POCKET 6: INSTRUMENTS 1 Emergency First Aid Guide 1 Plastic Tweezers 1 Scissors 6 Assorted Safety Pins 2 Wooden Finger Splints Copyright c 2010 Genuine First Aid LLC. All rights reserved. Manufactured in China for: Genuine First Aid LLC. 600 Cleveland Street Suite 400 Clearwater, FL 33755 www.GenuineFirstAid.com GENUINE FIRST AID", "GFA Kit 404" ], "set_id": "0d6181a4-55b4-464f-bdbe-cc82c6e26e8f", "id": "7e2f8c52-dae3-4e68-84b9-0e7701c46118", "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID*). . . . . . . . . . . . . Analgesic/Antipyretic *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20151111", "inactive_ingredient": [ "Inactive Ingredients Benzoic acid, bubblegum flavoring, citric acid, edetate disodium, glycerin, propylene glycol, purified water, saccharin sodium, sodium citrate dihydrate and sorbitol solution" ], "purpose": [ "Purpose Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not use to sedate a child or make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug.", "Ask a doctor before use if you have. heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis", "Ask a doctor or pharmacist before use if you are taking any other nasal decongestant or stimulant taking sedatives or tranquilizers", "When using this product Do not exceed recommended dosage. marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur if symptoms do not improve within 7 days or are accompanied by fever", "If pregnant or breast-feeding, ask a health professional before use." ], "questions": [ "Questions or Comments Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com ." ], "spl_product_data_elements": [ "LoHist PEB Brompheniramine Maleate and Phenylephrine Hydrochloride BENZOIC ACID ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE SORBITOL BROMPHENIRAMINE MALEATE BROMPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Do not exceed 6 doses in a 24-hour period. Age Dose Adults and children over 12 years of age 1 teaspoonsful (5 mL) every 4 hours Children 6 to under 12 years of age 1/2 teaspoonsful (2.5 mL) every 4 hours Children under 6 years of age Ask your doctor" ], "spl_unclassified_section": [ "Drug Facts", "Other Information store at 20°-25°C (68°-77°F) very low sodium, contains 4 mg sodium per 5 mL teaspoonful" ], "package_label_principal_display_panel": [ "Principal Display Panel Figure 1: 16 oz Bottle Label LoHist PEB label" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itching of the nose or throat itchy, watery eyes temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily restores freer breathing through the nose" ], "set_id": "0f4bc679-f4cf-44c3-b712-39995d8d951b", "id": "2445ac55-4b68-017f-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients In each 5 mL teaspoonful Brompheniramine Maleate, USP 4 mg Phenylephrine HCl, USP 10 mg" ], "dosage_and_administration_table": [ "
Age Dose
Adults and children over 12 years of age 1 teaspoonsful (5 mL) every 4 hours
Children 6 to under 12 years of age 1/2 teaspoonsful (2.5 mL) every 4 hours
Children under 6 years of age Ask your doctor
" ] }, { "effective_time": "20100607", "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive Ingredient: Purified water.", "Inactive ingredients flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose" ], "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Use: For preparation of skin before injection.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporary relief of minor aches, pains and headaches to reduce fever associated with colds, sore throats, teething" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only.", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product." ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Wipe Injection site vigorously and discard." ], "spl_product_data_elements": [ "ARC FIRST AID Contains 303 PIECES HARDCASE BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL,BENZOCAINE,ALCOHOL, ASPIRIN Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Chewable Aspirin ASPIRIN ASPIRIN ASPIRIN FD&C YELLOW NO. 6 SACCHARIN SODIUM CATION SILICON DIOXIDE STARCH, CORN STEARIC ACID SUCROSE ORANGE ASPIRIN Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B" ], "description": [ "LOT/EXP: Made in CHINA 20130301", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "LOT/EXP: Made in CHINA 20140301", "Made in CHINA LOT/EXP:", "MADE IN USA Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "ask_doctor": [ "Ask a doctor before use if you have; asthma stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems a child experiencing arthritis pain if you are; allergic to aspirin taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis" ], "openfda": {}, "version": "13", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions Do not use more than directed Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours, Do not exceed 48 tablets in 24 hours unless directed by a doctor. Children Under 12 years: Consult a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and ask a doctor if; an allergic reaction occurs, Seek medical help right away pain or fever persists new or unexpected symptoms occur redness or swelling is present ringing in ears or loss of hearing occurs" ], "storage_and_handling": [ "Other Information: Store at room temperature", "Other information: Store at room temperature.", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Flammable - keep away from fire or flame.", "Store at room temperature tamper evident sealed packets do not use any opened or torn packets" ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: with electrocautery, in the eyes.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you are allergic to aspirin or any other pain relievers/fever reducers for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor for at least 7 days after a tonsillectomy or oral surgery" ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Antiseptic Towelette", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "GenuineTripleAntibiotic", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "GenuineEyeWash", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AlcoholCleansingPad", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "2 Tablets GENUINE FIRST AID. Chewable Aspirin 81mg", "Chewable Aspirin 81mg", "American Red Cross Carrying Case 1 Soft-side Bag 1 Easy Access Pocket System Small Cuts and Burns 25 Adhesive Plastic Bandages 3/4\"x3\" 155 Junior Plastic Bandages 3/8\"x1-1/2\" 3 Adhesive Plastic Bandages 1\"x3\" 1 Knuckle Fabric Bandage 50 Adhesive Spot Bandages 7/8\"x7/8\" 1 Fingertip Fabric Bandage 1 Elbow/Knee Adhesive Bandage 1 Burn Cream 4 Antiseptic Towelettes 1 Triple Antibiotic Ointment 0.9gr 1 Sterile Gauze Pads 2\"x2\" 20 Cotton Tipped Applicators Medium Cuts and Scratches 4 Antiseptic Towelettes 1 Sterile Gauze Pad 2\"x2\" 1 Sterile Gauze Pad 3\"x3\" 1 Sterile Gauze Pad 4\"x4\" 1 Roller Gauze Bandage 2\"x4.1yds. 1 Sterile Eye Pad 1 Sterile Eye Wash 10ml 2 Butterfly Wound Closures Severe Bleeding and Burns 1 First Aid Tape Roll 1/2\"x2.5 yds. 1 Combine Pad 5\"x9\" 1 Combine Pad 8\"x10\" 1 Roller Gauze Bandage 3\"x4.1yds. CPR 1 CPR Breathing Barrier Protection 2 Medical Grade Vinyl Gloves 1 Instant Cold Compress 2 Alcohol Cleansing Pads 1 Insect Sting Relief Pads 1 Emergency Blanket 38\"x60\" 2 Chewable Aspirin Tablets 1 Triangular Bandage 42\"x42\"x59\" Instruments 1 Emergency First Aid Guide 1 Plastic Tweezers 1 Scissors 6 Assorted Safety Pins 2 Wooden Finger Splints Visit RedCross.org for information on training in First Aid, CPR, AED and more Manufactured in China for: Genuine First Aid LLC. 600 Cleveland Street Suite 400 Clearwater FL 33755 www.GenuineFirstAid.com GENUINE FIRST AID Copyright 2009 Genuine First Aid LLC. All rights reserved.", "ARCKit303HARDCASE" ], "set_id": "10239007-ca88-45fd-a567-70a75adcfeb5", "id": "badbeb85-1c35-4220-ae61-bf5052b41feb", "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID*). . . . . . . . . . . . . Analgesic/Antipyretic *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100607", "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive Ingredient: Purified water.", "Inactive ingredients flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose" ], "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Use: For preparation of skin before injection.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporary relief of minor aches, pains and headaches to reduce fever associated with colds, sore throats, teething" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only.", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product." ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Wipe Injection site vigorously and discard." ], "spl_product_data_elements": [ "ACME FIRST AID Contains 404 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN, BENZOCAINE, ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Chewable Aspirin ASPIRIN ASPIRIN ASPIRIN FD&C YELLOW NO. 6 SACCHARIN SODIUM CATION SILICON DIOXIDE STARCH, CORN STEARIC ACID SUCROSE ORANGE ASPIRIN Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B" ], "description": [ "LOT/EXP: Made in CHINA 20130301", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "LOT/EXP: Made in CHINA 20140301", "Made in CHINA LOT/EXP:", "MADE IN USA Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "ask_doctor": [ "Ask a doctor before use if you have; asthma stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems a child experiencing arthritis pain if you are; allergic to aspirin taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions Do not use more than directed Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours, Do not exceed 48 tablets in 24 hours unless directed by a doctor. Children Under 12 years: Consult a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and ask a doctor if; an allergic reaction occurs, Seek medical help right away pain or fever persists new or unexpected symptoms occur redness or swelling is present ringing in ears or loss of hearing occurs" ], "storage_and_handling": [ "Other Information: Store at room temperature", "Other information: Store at room temperature.", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Flammable - keep away from fire or flame.", "Store at room temperature tamper evident sealed packets do not use any opened or torn packets" ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: with electrocautery, in the eyes.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you are allergic to aspirin or any other pain relievers/fever reducers for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor for at least 7 days after a tonsillectomy or oral surgery" ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Antiseptic Towelette", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "GenuineTripleAntibiotic", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "GenuineEyeWash", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AlcoholCleansingPad", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "2 Tablets GENUINE FIRST AID. Chewable Aspirin 81mg", "Chewable Aspirin 81mg", "PhysiciansCARE FIRST AID all purpose kit with 6 First Aid Pockets 1 Small Cuts and Burns 2 Medium Cuts and Scratches 3 Severe Bleeding and Burns 4 CPR 5 Protection 6 Instruments New REFILL PACKS AVAILABLE FOR EACH POCKET HOME PLAY AUTO OFFICE WORK CONTAINS 1000 PIECES Soft-Sided Storage Case With Pockets that are Organized for Quick and Easy Emergency Access CARRYING CASE 1 Soft-sided Bag 1 Inside Plastic Pockets SMALL CUTS AND BURNS Pocket One 95 Adhesive Plastic Bandages 3/4\"x3\" 95 Junior Plastic Bandages 3/8\"x1-1/2\" 45 Adhesive Plastic Bandages 1\"x3\" 4 Knuckle Fabric Bandages 56 Adhesive Spot Bandages 7/8\"x7/8\" 4 Fingertip Fabric Bandages 3 Elbow/Knee Adhesive Bandage 1 Burn Cream 9 Antiseptic Towelettes 2 Triple Antibiotic Ointment 5 Sterile Gauze Pads 2''x2'' 20 Cotton Tipped Applicatiors MEDIUM CUTS AND SCRATCHES Pocket Two 12 Antiseptic Towelettes 5 Sterile Gauze Pad 2\"X2\" 2 Sterile Gauze Pad 3\"x3\" 2 Sterile Gauze Pad 4\"x4\" 1 Roll Gauze Bandages 2\" 1 Sterile Eye Pads 1 Sterile Eye Wash 5 Butterfly Wound Closures SEVERE BLEEDING AND BURNS Pocket Three 1 First Aid Tape Roll 1/2\" 1 Combine Pad 5\"x9\" 1 Combine Pad 8\"x10\" 1 Roll Gauze Bandage 3\" CPR Pocket Four 1 CPR Breathing Barrier PROTECTION Pocket Five 2 Medical Grade Gloves 1 Instant Cold Compress 6 Alcohol Cleansing Pads 2 Insect Sting Relief Pads 1 Emergency Blanket 38\"X 60\" 4 Chewable Aspirin Tablets 1 Triangular Bandage 42\"x42\"x59\" INSTRUMENTS Pocket Six 1 Emergency First Aid Guide 1 Plastic Tweezers 1 Scissors 6 Assorted Safety Pins 2 Wooden Finger Splints CAUTION: This kit contains products that have expiration dates. Please check before using. Acme United Corporation 60 Round Hill Road Fairfield, CT 06824 www.acmeunited.com Designed in USA / Made in India 2009 Acme United Corporation PhysiciansCare and are Registered Trademrks of Acme United Corporation", "ACMEKIT404" ], "set_id": "106eb41d-f74b-4975-945f-671f15e9343a", "id": "9f71f835-9965-4409-9cbe-44b04a0b0022", "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID*). . . . . . . . . . . . . Analgesic/Antipyretic *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20130321", "inactive_ingredient": [ "Inactive ingredients butylparaben, flavors, hydroxyethyl cellulose, propylparaben, purified water, saccharin sodium, simethicone, sorbitol" ], "purpose": [ "Active ingredients (in each 5 mL teaspoon) Purposes Aluminum hydroxide 500 mg Antacid Magnesium hydroxide 500 mg Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor before use if you have kidney disease a magnesium-restricted diet Ask a doctor or pharmacist if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks. Keep out of reach of children." ], "questions": [ "Questions or comments? 1-800-469-5268 (English) or 1-888-466-8746 (Spanish)" ], "spl_product_data_elements": [ "Mylanta Ultimate Strength aluminum hydroxide and magnesium hydroxide Aluminum Hydroxide Aluminum Hydroxide Magnesium Hydroxide Hydroxide Ion BUTYLPARABEN PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease a magnesium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions shake well adults/children 12 years and older: take 2-4 teaspoonfuls between meals, at bedtime, or as directed by a doctor do not take more than 9 teaspoonfuls in a 24-hour period, or use the maximum dosage for more than 2 weeks children under 12 years: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if symptoms last more than 2 weeks." ], "storage_and_handling": [ "Other Information each teaspoon contains: magnesium 215 mg do not use if breakaway band on plastic cap is broken or missing does not meet USP requirements for preservative effectiveness do not freeze" ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL teaspoon) Purposes
Aluminum hydroxide 500 mg Antacid
Magnesium hydroxide 500 mg Antacid
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Image not available PRINCIPAL DISPLAY PANEL" ], "indications_and_usage": [ "Use relieves: heartburn acid indigestion sour stomach upset stomach due to these symptoms overindulgence in food and drink" ], "set_id": "118b3162-b3e3-416d-9019-faf882af45d6", "id": "5f1d1915-e577-441e-b04b-d7cbdfcadb97", "purpose_table": [ "
Active ingredients (in each 5 mL teaspoon) Purposes
Aluminum hydroxide 500 mg Antacid
Magnesium hydroxide 500 mg Antacid
" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each 5 mL teaspoon) Purposes Aluminum hydroxide 500 mg Antacid Magnesium hydroxide 500 mg Antacid" ] }, { "effective_time": "20150416", "purpose": [ "Active ingredients (in each 15 mL) Purpose Acetaminophen 500 mg Pain reliever/Fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine Succinate 6.25 mg Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? 1-888-963-3382. You may also report side effects to this phone number." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each 15 mL contains: sodium 23 mg tamper evident: do not use if seal under bottle cap printed \"SEALED for YOUR PROTECTION\" is torn or missing dosing cup provided store between 15-30°C (59-86°F) Keep carton for full directions for use" ], "indications_and_usage": [ "Uses temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritation runny nose and sneezing minor aches and pains sore throat headache fever the impulse to cough to help you get to sleep" ], "set_id": "11f9df40-5009-4185-a139-9c34f52611ed", "id": "00ca7981-9fde-4dbc-9822-19c7f83a057f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredients (in each 15 mL) Purpose Acetaminophen 500 mg Pain reliever/Fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine Succinate 6.25 mg Antihistamine" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, anhydrous trisodium citrate, FD&C Blue #1, FD&C Red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sugar" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) a sodium restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. you are taking sedatives or tranquilizers. When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or persistent headache. These could be signs of a serious condition. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Delsym Night Time Cough and Cold Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Doxylamine Succinate Doxylamine anhydrous citric acid anhydrous trisodium citrate FD&C Blue No. 1 FD&C Red No. 40 glycerin polyethylene glycols propylene glycol water saccharin sodium sodium benzoate sucrose" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) a sodium restricted diet" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed (see Overdose warning ) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter Adults and Children 12 years and older: 30 mL in dosing cup provided every 6 hours. Children under 12 years of age: Do not use." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: Reckitt Benckiser Inc. Parsippany, NJ 07054-0224" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each 15 mL) Purpose
Acetaminophen 500 mg Pain reliever/Fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 120 mL Carton SEE NEW WARNINGS & INGREDIENTS Delsym ® NIGHT TIME COUGH & COLD Acetaminophen (Pain Reliever / Fever Reducer) Dextromethorphan HBr (Cough Suppressant) Doxylamine succinate (Antihistamine) Cough Runny Nose & Sneezing Sore Throat Body Aches Liquid 120 mL (4 fl oz) for Ages 12+ Principal Display Panel - 120 mL Carton" ], "purpose_table": [ "
Active ingredients (in each 15 mL) Purpose
Acetaminophen 500 mg Pain reliever/Fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine
" ] }, { "effective_time": "20150107", "purpose": [ "Active ingredients (in each 5mL) Purpose Pyrilamine Maleate 16 mg Antihistamine Phenylephrine HCl 5 mg Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 800-222-1222" ], "when_using": [ "may cause excitability, especially in children", "When using this product Do not exceed recommended dosage. drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? Call 1-800-793-2145" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use" ], "storage_and_handling": [ "Other Information store at controlled room temperature 20°-25°C (68°-77°F) Tamper Evident: Do not use if seal is broken or missing." ], "indications_and_usage": [ "Uses temporarily relieves runny nose relieves sneezing itching of the nose or throat itchy, watery eyes due to hay fever or other upper respiratory allergies nasal congestion due to the common cold" ], "set_id": "1241f208-3d9b-4f56-9bb1-d8a8d3c2fb65", "id": "a78fee05-7115-4b34-b966-02992cbf2aac", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use If you or your child are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each 5mL) Purpose Pyrilamine Maleate 16 mg Antihistamine Phenylephrine HCl 5 mg Nasal Decongestant" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and older 1 to 2 teaspoonsful
Children 6 to under 12 years of age 1 teaspoonful
Children under 6 years of age Ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients Citric acid, FD&C Blue No. 1, FD&C Red No. 40, glycerin, grape flavor, magnesium aluminum silicate, methylparaben, purified water, sodium saccharin, sodium benzoate, sodium citrate dihydrate, sucrose, xanthan gum and galloquinate." ], "warnings": [ "Warnings may cause excitability, especially in children do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure glaucoma a breathing problem such as emphysema, chronic bronchitis, or asthma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use If you or your child are taking sedatives or tranquilizers When using this product Do not exceed recommended dosage. drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs if symptoms do not improve within 7 days or are accompanied by fever. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 800-222-1222" ], "spl_product_data_elements": [ "Aldex D PHENYLEPHRINE HYDROCHLORIDE and PYRILAMINE MALEATE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PYRILAMINE MALEATE PYRILAMINE CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN GRAPE MAGNESIUM ALUMINUM SILICATE METHYLPARABEN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE XANTHAN GUM TANNIC ACID" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure glaucoma a breathing problem such as emphysema, chronic bronchitis, or asthma trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take every 6 hours do not take more than 4 doses in 24 hours or as directed by a doctor Adults and children 12 years of age and older 1 to 2 teaspoonsful Children 6 to under 12 years of age 1 teaspoonful Children under 6 years of age Ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs if symptoms do not improve within 7 days or are accompanied by fever." ], "do_not_use": [ "do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each 5mL) Purpose
Pyrilamine Maleate 16 mg Antihistamine
Phenylephrine HCl 5 mg Nasal Decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 65224-550-16 PERNIX THERAPEUTICS ALDEX ® D Antihistamine/Decongestant (Pyrilamine/Phenylephrine) Grape flavored suspension Shake well 16 fl. oz. (473 mL) Principal Display Panel - 473 mL Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 5mL) Purpose
Pyrilamine Maleate 16 mg Antihistamine
Phenylephrine HCl 5 mg Nasal Decongestant
" ] }, { "spl_product_data_elements": [ "Childrens Silapap Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 METHYLPARABEN PROPYLENE GLYCOL SACCHARIN SODIUM SODIUM BENZOATE WATER cherry flavor" ], "active_ingredient": [ "Active Ingredient: Acetaminophen 160 mg (in each 5 mL (TSP))" ], "purpose": [ "Purpose: Pain reliever/fever reducer" ], "indications_and_usage": [ "Uses To reduce fever and for the temporary relief of minor aches and pains due to: Headache Muscular aches Backache Minor pain of arthritis The common cold Toothache Premenstrual and menstrual cramps" ], "warnings": [ "Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Alcohol warning: If the user consumes 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Do not use with any other product drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if the user is allergic to acetaminophen or any of the inactive ingredients in this product When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 5 days fever gets worse or lasts for more than 3 days These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose Warning : In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs of symptoms." ], "do_not_use": [ "Do not use with any other product drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if the user is allergic to acetaminophen or any of the inactive ingredients in this product" ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning)" ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 5 days fever gets worse or lasts for more than 3 days These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "overdosage": [ "Overdose Warning : In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs of symptoms." ], "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning). if needed, repeat dose every 4 hours or as directed by a doctor do not give more than 5 doses in 24 hours children under 2 yrs (under 24 lbs) ask a doctor children 2-3 years (24-35 lbs) 1 teaspoonful (TSP)(5 mL) children 4-5 years (36-47 lbs) 1 1/2 teaspoonfuls (TSP)(7.5 mL) children 6-8 years (48-59 lbs) 2 teaspoonfuls (TSP)(10 mL) children 9-10 years (60-71 lbs) 2 1/2 teaspoonfuls (TSP)(12.5 mL) children 11 years (72-95 lbs) 3 teaspoonfuls (TSP)(15 mL) adults & children 12 years & older 4 teaspoonfuls (TSP)(20 mL) Other information Store at room temperature 20°-25°C (68°-77°F)" ], "dosage_and_administration_table": [ "
children under 2 yrs (under 24 lbs) ask a doctor
children 2-3 years (24-35 lbs) 1 teaspoonful (TSP)(5 mL)
children 4-5 years (36-47 lbs) 1 1/2 teaspoonfuls (TSP)(7.5 mL)
children 6-8 years (48-59 lbs) 2 teaspoonfuls (TSP)(10 mL)
children 9-10 years (60-71 lbs) 2 1/2 teaspoonfuls (TSP)(12.5 mL)
children 11 years (72-95 lbs) 3 teaspoonfuls (TSP)(15 mL)
adults & children 12 years & older 4 teaspoonfuls (TSP)(20 mL)
" ], "inactive_ingredient": [ "Inactive ingredients citric acid, D&C red no. 33, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, and purified water." ], "questions": [ "Questions 888-974-5279 This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol ® . Manufactured by: Silarx Pharmaceuticals, Inc 1033 Stoneleigh Ave. Carmel, NY 10512 USA" ], "package_label_principal_display_panel": [ "Container Label 237 mL" ], "set_id": "12f92dd0-5c7c-46f1-a44a-64af0f26686d", "id": "00a8f2c9-f087-456e-b9e6-c07eb71b8f86", "effective_time": "20140627", "version": "14", "openfda": {} }, { "effective_time": "20100726", "inactive_ingredient": [ "Inactive ingredients Sorbitol, Water, Hydrated Silica, Polyethylene Glycol 1450, Sodium Carboxymethylcellulose, Flavor, Sodium Lauryl Sulfate, Sodium Saccharin, Sodium Methylparaben, Mica, Propyparaben, Titanium Dioxide, D C Red 33, FD C Blue 1." ], "purpose": [ "PURPOSE Anticavity" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS Keep out of reach of children under 6 years of age . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Walgreens Scooby Doo Fluoride Gel Toothpaste Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER SILICON DIOXIDE POLYETHYLENE GLYCOL 1450 CARBOXYMETHYLCELLULOSE SODIUM SODIUM LAURYL SULFATE SACCHARIN SODIUM METHYLPARABEN SODIUM PROPYLPARABEN TITANIUM DIOXIDE D&C RED NO. 33 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not swallow instruct children under 6 years in good rinsing habits (to reduce swallowing) supervise children as necessary until capable of using with our supervision adults and children 2 years and over: brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist or doctor children under 2 years: consult a dentist or doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel image of container" ], "indications_and_usage": [ "USE Aids in the prevention of dental decay." ], "set_id": "14039307-3fe6-4623-9709-1eccf3500f3e", "id": "33e7c7b7-299b-42c2-86e4-fcc30dbeb8b1", "active_ingredient": [ "Active Ingredients Sodium Fluoride 0.24% Anticavity" ] }, { "effective_time": "20121011", "purpose": [ "Purpose Expectorant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product, do not take more than directed." ], "questions": [ "Questions? 1-800-873-8276" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains: potassium 5 mg, sodium 49 mg store at room temperature" ], "indications_and_usage": [ "Uses helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus temporarily relieves nasal congestion due to a cold or hay fever or other upper respiratory allergies" ], "set_id": "14685a2b-ef61-443e-8d92-06c7857a1e75", "id": "babf077e-5d8b-4cb7-a2fd-4b5ac2dded10", "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Guaifenesin 100 mg Phenylephrine HCl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 30 ml (2 TBSP) every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, carboxymethylcellulose sodium, citric acid, disodium EDTA, FD&C Blue No. 1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol" ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a sodium-restricted diet When using this product, do not take more than directed. Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Vicks VapoSyrup Guaifenesin and Phenylephrine Hydrochloride Guaifenesin Guaifenesin Phenylephrine Hydrochloride Phenylephrine acesulfame potassium carboxymethylcellulose sodium citric acid monohydrate edetate disodium FD&C Blue No. 1 glycerin propylene glycol water saccharin sodium dihydrate sodium benzoate sodium chloride trisodium citrate dihydrate sorbitol" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a sodium-restricted diet" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions shake well before use use dose cup or tablespoon (TBSP) do not exceed 6 doses per 24 hours adults and children 12 years and over 30 ml (2 TBSP) every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202. www.vicks.com" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 295 ml Bottle Label NEW VICKS ® VapoSyrup™ Mint Splash™ Flavor With Soothing Vicks Vapors SEVERE CONGESTION Head & Chest Congestion Relief Guaifenesin…Expectorant Phenylephrine…Nasal Decongestant 10 FL OZ (295 ml) See Drug Facts Principle Display Panel - 295 ml Bottle Label" ] }, { "effective_time": "20141106", "inactive_ingredient": [ "Inactive Ingredients Sorbitol, Water, Hydrated Silica, Calcium Carbonate, Sodium Lauryl Sulfate,Carboxymethyl Cellulose, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Methyl Paraben, FD&C Blue 1." ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of Reach of children Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "questions": [ "Questions? +1-512-653-8814" ], "spl_product_data_elements": [ "FreshDent Cavity Protection Anticavity SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL GLYCERIN WATER SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM LAURYL SULFATE TITANIUM DIOXIDE SACCHARIN SODIUM METHYLPARABEN SODIUM FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor." ], "package_label_principal_display_panel": [ "Package Label Anticavity Toothpaste FreshDent we care Cavity Protection Strengthens teeth with Active Fluoride Net Wt. 0.85 oz (24 g) Distributed by: FreshDent LLC Crockett, TX 75835 www.freshdent.net Made in Egypt CavityBox CavityTube" ], "indications_and_usage": [ "Use Aids in the prevention of dental cavities" ], "set_id": "16ac653c-0bad-4d3b-a060-1be1444f28af", "id": "a5acc4f6-b53f-4a17-a889-ef681cfdf27b", "active_ingredient": [ "Active Ingredients Sodium Monofluorophosphate 0.76% (0.085% w/v fluoride ion)" ] }, { "effective_time": "20130213", "inactive_ingredient": [ "Inactive ingredients alcohol, butylparaben, FD&C red #40, flavors, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, propylparaben, purified water, saccharin sodium, sorbitol solution" ], "purpose": [ "Active ingredients (in each 5 mL teaspoon) Purposes Aluminum hydroxide (equivalent to dried gel, USP) 400 mg Antacid Magnesium hydroxide 400 mg Antacid Simethicone 40 mg Antigas" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor before use if you have kidney disease a magnesium-restricted diet Ask a doctor or pharmacist if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks. Keep out of reach of children." ], "questions": [ "Questions or comments? 1-800-469-5268 (English) or 1-888-466-8746 (Spanish)" ], "spl_product_data_elements": [ "MYLANTA Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone Aluminum Hydroxide Aluminum Hydroxide Magnesium Hydroxide Hydroxide Ion Dimethicone Dimethicone alcohol butylparaben carboxymethylcellulose sodium FD&C Red No. 40 Hypromelloses Cellulose, Microcrystalline Propylparaben Water Saccharin Sodium Sorbitol" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions shake well adults/children 12 years and older: take 2-4 teaspoonfuls between meals, at bedtime, or as directed by a doctor do not take more than 12 teaspoonfuls in a 24-hour period, or use the maximum dosage for more than 2 weeks children under 12 years: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if symptoms last more than 2 weeks." ], "storage_and_handling": [ "Other information each teaspoon contains: magnesium 171 mg do not use if breakaway band on plastic cap is broken or missing does not meet USP requirements for preservative effectiveness store between 20-25°C (68-77°F) do not freeze" ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL teaspoon) Purposes
Aluminum hydroxide (equivalent to dried gel, USP) 400 mg Antacid
Magnesium hydroxide 400 mg Antacid
Simethicone 40 mg Antigas
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Image not available Principal Display Panel" ], "indications_and_usage": [ "Use relieves: heartburn acid indigestion sour stomach upset stomach due to these symptoms pressure and bloating commonly referred to as gas" ], "set_id": "16db6713-dd6f-41c3-b2f0-2d769655b106", "id": "59dbe6e3-731d-40b7-9717-564d3e9eedb5", "purpose_table": [ "
Active ingredients (in each 5 mL teaspoon) Purposes
Aluminum hydroxide (equivalent to dried gel, USP) 400 mg Antacid
Magnesium hydroxide 400 mg Antacid
Simethicone 40 mg Antigas
" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each 5 mL teaspoon) Purposes Aluminum hydroxide (equivalent to dried gel, USP) 400 mg Antacid Magnesium hydroxide 400 mg Antacid Simethicone 40 mg Antigas" ] }, { "effective_time": "20140507", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, GREEN 3 (CI 42053)" ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)" ], "warnings": [ "WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)" ], "spl_product_data_elements": [ "DISCOUNT DRUG MART BLUE MINT MOUTHWASH EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE FD&C GREEN NO. 3" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW" ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT, ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS" ], "set_id": "1724227f-fadd-4b31-831e-d4e7ccba7292", "id": "7c264e6b-f8f1-4d84-81b4-b38571ee2bc0", "active_ingredient": [ "ACTIVE INGREDIENTS EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20100603", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "questions": [ "Questions? 1-800-362-1683" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains: potassium 5 mg, sodium 19 mg store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing" ], "set_id": "17387d2c-8895-4d57-b0ba-2113bed742db", "id": "5bf4433c-09e7-4e6b-a440-88729c4a389a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "dosage_and_administration_table": [ "
adults & children 12 yrs and over 30 ml (2 TBSP) every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, alcohol, citric acid, FD&C Blue 1, FD&C Red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate" ], "warnings": [ "Warnings Liver warning Product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hrs with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than directed dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Vicks NyQuil Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine succinate Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Doxylamine succinate Doxylamine" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hrs adults & children 12 yrs and over 30 ml (2 TBSP) every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other DayQuil® or NyQuil products, carefully read each label to insure correct dosing" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202. www.vicks.com" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 295 ml Bottle Label Special Edition Cherry Vanilla Swirl VICKS ® NyQuil ® COLD & FLU Multi-Symptom Relief Acetaminophen…Aches, Fever Dextromethorphan…Cough Doxylamine…Sneezing, Runny Nose 10 FL OZ (295 ml) Alcohol 10% See Drug Facts Principle Display Panel - 295 ml Bottle Label" ], "overdosage": [ "Overdose warning Taking more than directed dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20080825", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Sorbitol, Silica, Treated Water (Aqua), Glycerin, Polyethylene Glycol 1500, Sodium Lauryl Sulphate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, Methylparaben, Propylparaben, Color: FD & C Blue # 1." ], "purpose": [ "PURPOSE: Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately." ], "warnings": [ "WARNINGS: Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Freshmint Premium Anticavity SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL SILICON DIOXIDE WATER GLYCERIN POLYETHYLENE GLYCOL 1500 SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE SACCHARIN SODIUM DIHYDRATE SODIUM BENZOATE SODIUM PYROPHOSPHATE METHYLPARABEN PROPYLPARABEN FD&C BLUE NO. 1 MINT" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS: Adults and children 2 years & older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. To minimize swallowing use a pea-sized amount in children under 6 years of age. Supervise children's brushing until good habits are established. Children under 2 years: Ask a dentist." ], "spl_unclassified_section": [ "Drug Facts" ], "package_label_principal_display_panel": [ "Principal Display Panel – Tube Label ADA Accepted American Dental Association ® freshmint ® Premium Anticavity Toothpaste NET WT. 0.85 oz Principal Display Panel – Tube Label" ], "indications_and_usage": [ "USES: Helps protect teeth and roots against cavities." ], "set_id": "19605e5a-f1cd-4b7b-856c-7d4305baba7e", "id": "b9087431-c1ac-481c-90e1-e93e97e58bcf", "active_ingredient": [ "ACTIVE INGREDIENT: Sodium Fluoride - 0.243% (0.15% w/v fluoride ion)" ] }, { "effective_time": "20121109", "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number." ], "spl_product_data_elements": [ "Childrens Mucinex Chest Congestion Guaifenesin Guaifenesin Guaifenesin acesulfame potassium anhydrous citric acid FD&C blue no. 1 FD&C red no. 40 glycerin maltitol propylene glycol water saccharin sodium sodium benzoate sorbitol sucralose xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products mL = milliliter Age Dose children 6 years to under 12 years 5 mL – 10 mL every 4 hours children 4 years to under 6 years 2.5 mL – 5 mL every 4 hours children under 4 years do not use" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness." ], "storage_and_handling": [ "Other information tamper evident: do not use if printed neckband on bottle cap is broken or missing store between 20-25°C (68-77°F) do not refrigerate dosing cup provided" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton NDC 63824-280-64 Children's Mucinex ® Chest Congestion Guaifenesin Oral Solution, USP Expectorant ✓ Chest Congestion ✓ Breaks up Mucus ✓ Alcohol-free Grape Flavor Liquid 4 FL OZ (118 mL) Principal Display Panel - 118 mL Bottle Carton" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive" ], "set_id": "1daa3c05-eaeb-4219-a959-4959750a30a0", "id": "65cb02de-aa36-4bce-9045-79448592daae", "active_ingredient": [ "Active ingredient (in each 5 mL) Guaifenesin, USP 100 mg" ], "dosage_and_administration_table": [ "
Age Dose
children 6 years to under 12 years 5 mL – 10 mL every 4 hours
children 4 years to under 6 years 2.5 mL – 5 mL every 4 hours
children under 4 years do not use
" ] }, { "effective_time": "20110512", "inactive_ingredient": [ "Inactive Ingredients Calcium Carbonate, Sodium Carboxy Methyl Cellulose, Sodium Saccharin, Sodium Lauryl Sulfate, Flavour, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium and Cl 16255 Q.S." ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a poison control center immediately." ], "warnings": [ "Warning Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a poison control center immediately." ], "spl_product_data_elements": [ "Amerfresh Sodium Monofluorophosphate Sodium Monofluorophosphate fluoride ion Calcium Carbonate Carboxymethylcellulose Sodium Saccharin Sodium Sodium Lauryl Sulfate Methylparaben Sodium Propylparaben Sodium Silicon Dioxide Ponceau 4R" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician. Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing. Children under 2 years Ask a Dentist or physician." ], "spl_unclassified_section": [ "DRUG FACTS", "Exclusive Distributor: AMERCARE Products Inc. Seattle. WA 98165-2226." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 446 g Carton AMERFRESH ® FLUORIDE TOOTHPOWDER NET WEIGHT 1 lb (446 g) Principal Display Panel - 446 g Carton" ], "indications_and_usage": [ "Use helps protect against cavities" ], "set_id": "1e09d9ed-b8e2-4998-845b-93ed861542be", "id": "843e8d6b-8bb6-4c81-8089-8a500ebe6bd4", "active_ingredient": [ "Active Ingredient Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)" ], "dosage_and_administration_table": [ "
Adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician.
Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
Children under 2 years Ask a Dentist or physician.
" ] }, { "effective_time": "20121011", "inactive_ingredient": [ "Inactive ingredients carboxymethylcellulose sodium, citric acid, D&C Yellow No. 10, FD&C Yellow No. 6, flavor, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if you have a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-800-251-3374" ], "spl_product_data_elements": [ "Vicks DayQuil Mucus Control Guaifenesin Guaifenesin Guaifenesin carboxymethylcellulose sodium citric acid monohydrate D&C Yellow No. 10 FD&C Yellow No. 6 high fructose corn syrup propylene glycol water saccharin sodium dihydrate sodium benzoate sodium citrate" ], "ask_doctor": [ "Ask a doctor before use if you have a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions use dose cup or tablespoon (TBSP) do not exceed 6 doses per 24 hours adults and children 12 years and over 30 ml (2 TBSP) every 4 hours children 6 to under 12 years 15 ml (1 TBSP) every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use when using other DayQuil or NyQuil® products, carefully read each label to insure correct dosing" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202. www.vicks.com" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each tablespoon contains sodium 25 mg store at room temperature" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 295 ml Bottle Label NEW VICKS ® NON-DROWSY DayQuil ® Mucus Control™ EXPECTORANT Maximum Strength 4 hour Formula Guaifenesin...Expectorant 10 FL OZ (295 ml) Citrus Blend Flavor See Drug Facts Principle Display Panel - 295 ml Bottle Label" ], "indications_and_usage": [ "Use helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus" ], "set_id": "21064f47-f23d-4da1-8faf-3c6842893864", "id": "fec90bc7-4524-4b74-9d3b-32fdee3bd608", "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Guaifenesin 200 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 30 ml (2 TBSP) every 4 hours
children 6 to under 12 years 15 ml (1 TBSP) every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years do not use
" ] }, { "effective_time": "20150330", "inactive_ingredient": [ "Inactive ingredients citric acid, D&C yellow #10, FD&C red #40, glycerin, propylene glycol, purified water, red raspberry flavor, saccharin sodium, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Cough suppressant Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "spl_product_data_elements": [ "Iophen DM NR dextromethorphan and guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE D&C YELLOW NO. 10 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL clear red raspberry" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with excessive phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions take every 4 hours do not take more than 6 doses in any 24-hour period adults and children 12 years and over take 10 mL (2 tsp) children 6 years to under 12 years take 5 mL (1 tsp) children 2 years to under 6 years take 2.5 mL (1/2 tsp) children under 2 years do not use Attention: Only use the measuring spoons or cups that are made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "spl_unclassified_section": [ "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev. 2/15 R5 8066060 1330" ], "storage_and_handling": [ "Other information store at 15° to 30°C (59° to 86°F) You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811." ], "do_not_use": [ "Do not use in a child under 2 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is an image of the Iophen DM-NR Liquid label." ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive" ], "set_id": "21312fd4-92e9-41da-b392-78031d4f7e34", "id": "9d402429-5743-4457-9d53-1a0c1a0a1a5e", "active_ingredient": [ "Active ingredient (in each 5 mL = 1 tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 10 mL (2 tsp)
children 6 years to under 12 years take 5 mL (1 tsp)
children 2 years to under 6 years take 2.5 mL (1/2 tsp)
children under 2 years do not use
" ] }, { "effective_time": "20121210", "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous citric acid, artificial & natural flavors, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum" ], "purpose": [ "PURPOSES Cough suppressant Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "QUESTIONS OR COMMENTS? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675" ], "spl_product_data_elements": [ "ROBITUSSIN COUGH AND CHEST CONGESTION DM MAX dextromethorphan HBr, guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN HIGH FRUCTOSE CORN SYRUP MENTHOL CELLULOSE, MICROCRYSTALLINE POVIDONES PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL XANTHAN GUM thick red opaque liquid" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS shake well before using do not take more than 6 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 teaspoons every 4 hours children under 12 years do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION each teaspoon contains: sodium 5 mg store at 20-25°C (68-77°F) alcohol-free dosage cup provided" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. See New Dosing Information Adult Robitussin Cough & Chest Congestion DM Max DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) NON-DROWSY RELIEVES: Cough Chest Congestion/Mucus Maximum Strength for MUCUS RELIEF For Ages 12 & Over Alcohol-Free 4 FL OZ (118 mL) Robitussin Knows Choosing the right product is important. Robitussin has different products for adults and for children. GREEN Boxes Ages 12 & Over RED Boxes Ages Under 12 Use as directed DOSAGE CUP INCLUDED Wyeth Consumer Healthcare Madison, NJ 07940 U.S.A. © 2009 Wyeth For most recent product information, visit www.robitussin.com PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. Robitussin Cough & Chest Congestion DM Max Packaging" ], "indications_and_usage": [ "USES temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes" ], "set_id": "221cf9ad-0856-41e6-f783-9b17b4ec1dab", "id": "f84dc460-80d1-4d3e-9ba8-b185ed0fb380", "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH 5 ML TSP) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 200 mg" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over 2 teaspoons every 4 hours
children under 12 years do not use
" ] }, { "effective_time": "20140521", "inactive_ingredient": [ "Inactive Ingredients Liquid Sorbitol, Dental-Type Silica, Sodium Chloride, Sodium Lauryl sulphate, Sodium carboxymethylcellulose, Panthenol, Polyethylene Glycol 1500, Saccharin Sodium Hydrate, Phosphoric acid, Water" ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Dental Clinic 2080 K Citrus Cool Mint SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION POLYGLUCOSE SORBITOL CARBOXYMETHYL ETHER SILICA DIMETHYL SILYLATE SODIUM CHLORIDE SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM PANTHENOL POLYETHYLENE GLYCOL 1500 SACCHARIN SODIUM PHOSPHORIC ACID WATER Citrus Cool Mint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow. supervise children as necessary until capable of using without supervision. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor. Children under 2 years of age: Consult a dentist or doctor." ], "spl_unclassified_section": [ "Dental Clinic 2080 K Toothpaste Citrus Cool Mint", "Dental Clinic 2080 Gingivalis Project K Gingivitis-causing Bacteria 99% Inhibits in-vitro test Results Tested by Dental School Clinic Dental Clinic 2080 K Toothpaste Citrus Cool Mint OTC Drug Customer Center:060-024-1357 (Nationwide Toll-Free) We accept returns in compliance with the Consumer Protection Act of Fair Trade Commission. AEKYUNG MADE IN KOREA www.aekyung.co.kr Net Weight: 100g" ], "package_label_principal_display_panel": [ "Dental Clinic 2080 K Toothpaste Citrus Cool Mint, 100g (67225-0003-1) CitrusCoolMint" ], "indications_and_usage": [ "Use Aids in the prevention of dental cavities." ], "set_id": "22330f78-f719-4109-b0f9-c953fb5665ff", "id": "46dbc0b3-59e7-4459-8061-f4c275da7f76", "active_ingredient": [ "Active Ingredient Sodium Fluoride 0.22% (0.1% w/v fluoride ion)" ] }, { "effective_time": "20150318", "inactive_ingredient": [ "Inactive Ingredients flavor, glycerin, purified water, saccharin sodium, sodium benzoate" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "purpose": [ "1 tablespoon contains: sodium 1668 mg this product is sugar-free this product usually causes a person to have a bowel movement in 30 minutes to 6 hours chill this product in refrigerator to improve the taste. Do not freeze" ], "warnings": [ "Warnings Taking more than the recommended dose in 24 hours can be harmful. Do not use if you have congestive heart failure if you have serious kidney problems in children under 5 years of age" ], "questions": [ "Questions? 1-888-999-9711 or www.phosphosoda.com" ], "spl_product_data_elements": [ "Fleet sodium phosphate, dibasic and sodium phosphate, monobasic SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE PHOSPHATE ION SODIUM CATION WATER GLYCERIN SACCHARIN SODIUM SODIUM BENZOATE SODIUM PHOSPHATE, MONOBASIC PHOSPHATE ION SODIUM CATION Ginger Lemon Flavor" ], "ask_doctor": [ "Ask a doctor before use if you are under a doctor's care for any medical condition on a low salt diet Ask a doctor or pharmacist before use if you are taking any other prescription or non-prescription drugs. Ask a doctor before using any laxative if you have abdominal (belly) pain, nausea, or vomitting a change in your daily bowel movements that lasts more than 2 weeks already used another laxative daily for constipation for more than 1 week" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Laxative Dose and Directions Ages (years) Step 1 Step 2 24 Hour Max Dose* 12 years & older Mix 1 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 3 tablespoons 10 to 11 years Mix 1 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 1 tablespoon 5 to 9 years Mix 1/2 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 1/2 tablespoon Under 5 years Do Not Use Do Not Use Do Not Use * Take no more than this amount in a 24 hour period. Use as a laxative for relieft of occasional constipation. follow the dose and directions. do not take more unless directed by a doctor. See Warnings. drink as much extra liquids as you can to help replace the fluids you are losing during bowel movements." ], "stop_use": [ "Stop use and ask a doctor if you have any rectal bleeding do not have a bowel movement within 6 hours of taking this product have any symptoms that your body is losing more fluids than you are drinking. This is called dehydration. Early symptoms of dehydration include - feeling thristy - dizziness - urinating less often than normal - vomiting These symptoms may be signs of serious problems." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "Uses relief of occasional constipation to help clean out the bowel before medical procedures" ], "set_id": "22f3fe8f-e12a-4a5f-9fb3-2b6cc94c8573", "id": "6e227692-75c8-4564-8e63-7bb68bd81edf", "active_ingredient": [ "Active Ingredient (in each Tablespoon) Monobasic Sodium Phosphate 7.2 g.................Saline Laxative / Bowel Cleanser Dibasic Sodium Phosphate 2.7 g......................Saline Laxative / Bowel Cleanser" ], "dosage_and_administration_table": [ "
Laxative Dose and Directions
Ages (years) Step 1 Step 2 24 Hour Max Dose*
12 years & older Mix 1 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 3 tablespoons
10 to 11 years Mix 1 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 1 tablespoon
5 to 9 years Mix 1/2 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 1/2 tablespoon
Under 5 years Do Not Use Do Not Use Do Not Use
" ] }, { "effective_time": "20140624", "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol and sucralose." ], "purpose": [ "Purpose Purpose: Pain reliever/Fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately . Prompt medical attention is critical even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: ■ more than 5 doses in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen Sore throat warning : if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. Stop use and ask a doctor if ■ new symptoms occur ■ redness or swelling is present ■ pain gets worse or lasts for more than 5 days ■ fever gets worse or lasts for more than 3 days. These could be signs of serious condition. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately . Prompt medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Manufactured by: Ballay Pharmaceuticals, Inc. 200 Stillwater Wimberley, TX 78676" ], "spl_product_data_elements": [ "Childrens Nortemp Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM DIHYDRATE SORBITOL SUCRALOSE WATER" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Shake well Age (year) Weight (lb) Under 2 Under 24 2 - 3 24 - 35 4 - 5 36 - 47 6 - 8 48 - 59 9 - 10 60 - 71 11 72 - 95 Dose (tsp.) Consult Doctor 1 1 1/2 2 2 1/2 3 All dosages may be repeated every 4 hours, but not more than 5 times daily. this product does not contain directions or complete warnings for adult use. Other information Store between 20°-25°C (68°-77°F) in a tight container. Each teaspoon contains: Sodium 7 mg" ], "stop_use": [ "Stop use and ask a doctor if ■ new symptoms occur ■ redness or swelling is present ■ pain gets worse or lasts for more than 5 days ■ fever gets worse or lasts for more than 3 days. These could be signs of serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "package_label_principal_display_panel": [ "Childrens Nortemp Label" ], "indications_and_usage": [ "Uses ■ Temporarily reduces fever ■ Temporarily relieves minor aches and pains associated with a cold, flu, sore throat, headache and toothache." ], "set_id": "2321b5fb-9b3a-4435-8deb-e8cfd2208b43", "id": "8742a375-a463-41bf-b9d7-1fc303dcd62f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin." ], "active_ingredient": [ "Drug Facts Active Ingredient: Acetaminophen 160mg (in each 5 mL (tsp.))" ], "dosage_and_administration_table": [ "
Age (year) Weight (lb) Under 2 Under 24 2 - 3 24 - 35 4 - 5 36 - 47 6 - 8 48 - 59 9 - 10 60 - 71 11 72 - 95
Dose (tsp.) Consult Doctor 1 1 1/2 2 2 1/2 3
" ] }, { "effective_time": "20121105", "inactive_ingredient": [ "Inactive ingredients Cherry flavor, glycerin, purified water, saccharin sodium, sodium benzoate" ], "purpose": [ "Purpose Saline laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Dosage warning Taking more than the recommended dose in 24 hours can be harmful. Do not use if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities in children under 5 years of age for bowel cleansing Ask a doctor before use if you have abdominal pain, nausea, or vomiting kidney disease heart problems a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than a week a dehydration condition Ask a doctor or pharmacist before use if you are on a sodium restricted diet under a doctor’s care for any medical condition taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. Stop use and ask a doctor if you have any rectal bleeding do not have a bowel movement within 6 hours have any symptoms that your body is losing more fluid than you are drinking have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting. These symptoms may indicate a serious condition. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "questions": [ "Questions 1-800-633-5463" ], "spl_product_data_elements": [ "Oral Saline Laxative Cherry dibasic sodium phosphate, monobasic sodium phosphate SODIUM PHOSPHATE, DIBASIC PHOSPHATE ION SODIUM PHOSPHATE, MONOBASIC PHOSPHATE ION GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain, nausea, or vomiting kidney disease heart problems a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than a week a dehydration condition" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use as a laxative for relief of occasional constipation dilute dose in the table below with one glass (8 fl. oz.) cool water. Drink, then follow with at least one additional glass (8 fl. oz.) cool water. There is significant loss of liquid when using this product. To prevent dehydration drink plenty of clear liquid after use. Do not use for bowel cleansing. Do not take more unless directed by a doctor. See Warning. There are three Teaspoons in one Tablespoon. Ages (Years) Dosage Maximum Dose 12 & Older 3 Teaspoons 6 or 9 Teaspoons* 10 & 11 3 Teaspoons* 3 Teaspoons* 5 to 9 1 1/2 Teaspoons* 1 1/2 Teaspoons* under 5 Do Not Use Do Not Use *SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have any rectal bleeding do not have a bowel movement within 6 hours have any symptoms that your body is losing more fluid than you are drinking have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting. These symptoms may indicate a serious condition." ], "storage_and_handling": [ "Other information Each Teaspoon contains: sodium 556 mg Saline laxatives increase retention of water in the intestine, promoting bowel movements. this product generally produces a bowel movement in 30 minutes to 6 hours this product is sugar free do not freeze store at room temperature TAMPER EVIDENT: Mouth of bottle sealed for your safety. If foil seal is missing or broken, do not use." ], "do_not_use": [ "Do not use if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities in children under 5 years of age for bowel cleansing" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel sunmark NDC 49348-110-12 ORAL SALINE LAXATIVE Sugar Free For relief of occasional constipation Single dose container CHERRY FLAVOR 1.5 FL OZ (45 mL) Sunmark Oral Saline Laxative Cherry Flavor Principal Display Panel", "Package Drug Facts 1 Sunmark Oral Saline Laxative Cherry Flavor Drug Facts", "Package Drug Facts 2 Sunmark Oral Saline Laxative Cherry Flavor Drug Facts Continued" ], "indications_and_usage": [ "Use for relief of occasional constipation" ], "set_id": "256cf9d9-67d1-4f6c-abed-42b9cd7604fc", "id": "256cf9d9-67d1-4f6c-abed-42b9cd7604fc", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are on a sodium restricted diet under a doctor’s care for any medical condition taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient (in each tablespoon) Dibasic sodium phosphate 2.7 g Monobasic sodium phosphate 7.2 g" ], "dosage_and_administration_table": [ "
Ages (Years) Dosage Maximum Dose
12 & Older 3 Teaspoons 6 or 9 Teaspoons*
10 & 11 3 Teaspoons* 3 Teaspoons*
5 to 9 1 1/2 Teaspoons* 1 1/2 Teaspoons*
under 5 Do Not Use Do Not Use
" ] }, { "effective_time": "20150327", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, artificial flavor, caramel, FD&C red no. 40, glycerin, high fructose corn syrup, liquid glucose, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675" ], "spl_product_data_elements": [ "Robitussin Mucus Plus Chest Congestion Guaifenesin GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID CARAMEL DEXTROSE FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL, (R)- SACCHARIN SODIUM SODIUM BENZOATE WATER GLYCERIN deep wine" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product ml=milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10-20 ml every 4 hours children under 12 years do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Pfizer, Madison, NJ 07940 USA For most recent product information, visit www.robitussin.com" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each 10 ml contains: sodium 4 mg store at 20-25°C (68-77°F). Do not refrigerate alcohol-free" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label ADULT Robitussin ® Mucus + Chest Congestion GUAIFENESIN (Expectorant) Alcohol-Free 4 FL OZ (118 ml) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton ADULT Robitussin ® Mucus + Chest Congestion GUAIFENESIN (Expectorant) Relieves: ✓ Mucus ✓ Chest Congestion Alcohol-Free ORIGINAL For Ages 12 & Over 4 FL OZ (118 ml) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton" ], "indications_and_usage": [ "Use helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive" ], "set_id": "259c8b69-c625-4146-b888-34ef43b8385f", "id": "79db3cc6-0367-4120-9b42-68ff68b0e807", "active_ingredient": [ "Active ingredient (in each 10 mL) Guaifenesin, USP 200 mg" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over 10-20 ml every 4 hours
children under 12 years do not use
" ] }, { "effective_time": "20110215", "inactive_ingredient": [ "Inactive ingredients Benzoyl alcohol, butylparaben, carboxy methylcellulose sodium, flavor, hypromelloses, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution." ], "purpose": [ "" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children" ], "warnings": [ "Warnings Ask a doctor before use if you have • kidney disease • a magnesium restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if syptoms last more than 2 weeks. KEEP OUT OF REACH OF CHILDREN. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING" ], "spl_product_data_elements": [ "Almacone Almacone ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM HYDROXIDE BENZYL ALCOHOL BUTYLPARABEN CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE HYPROMELLOSES PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Shake well before use. Do not take more than 24 teaspoonful in 24 hours or use the maximum dosage for more than 2 weeks. Adults and children 12 years and older: take 2 to 4 teaspoonsfuls between meals, at bedtime, or as directed by a doctor. Children under 12 years: ask a doctor." ], "spl_unclassified_section": [ "Other Information Each 5 mL teaspoon contains: magnesium 25 mg, sodium 1 mg. Store at room temperature. Protect from freezing. Keep tighly closed.", "How Supplied Almacone (antacid) is supplied in 12 oz. bottles NDC 21695-840-12 Questions or comments? Call 1-800-645-2158, 9 am - 5 pm EST, Monday-Friday. Distributed by: Rugby Laboratories Duluth, GA 30097 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Almacone (Antacid) 200mg/ 200mg/ 20mg" ], "indications_and_usage": [ "Uses Use(s) Enter section text here Uses relieves • heartburn • acid indigestion • sour stomach • gas associated with these conditions" ], "set_id": "25df52b1-c0b3-49ea-b97f-0763b64db011", "id": "25df52b1-c0b3-49ea-b97f-0763b64db011", "active_ingredient": [ "Active ingredients Aluminum Hydroxide 200mg Magnesium Hydroxide 200mg" ] }, { "effective_time": "20100817", "inactive_ingredient": [ "Inactive Ingredients d-sorbitol solution, glycerin, peppermint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium" ], "purpose": [ "Purpose Oral pain reliever Uses temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In cases of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings for temporary use only until a dentist can be consulted Allergy alert: do not use this product if you have a history of allergy to local anesthetics such a procaine, butacaine, benzocaine or other \"caine\" anesthetics." ], "questions": [ "Questions? Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM." ], "spl_product_data_elements": [ "Oral Analgesic Maximum Strength Benzocaine Benzocaine Benzocaine Sorbitol Glycerin Peppermint Polyethylene Glycol 400 Polyethylene Glycol 4000 Saccharin Sodium" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions remove cap and cut tip of tube on score mark adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. use up to 4 times daily or as directed by a doctor or dentist. children under 12 year of age: should be supervised in the use of this product children under 2 years of age: ask a doctor/dentist" ], "stop_use": [ "Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops" ], "storage_and_handling": [ "Other information store at 15 o to 25 o (50 o to 77 o F) This preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted. Do not use continuously Lot No. and Exp. Date: see box or see crimp of tube" ], "package_label_principal_display_panel": [ "Image of Oral Analgesic Gel Carton Label Image of Oral Analgesic Gel Tube Label" ], "indications_and_usage": [ "When using this product do not use more than directed do not use for more than 7 days unless directed by a doctor/dentist do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist" ], "set_id": "2670754a-0fc5-4d08-a851-c8b725572826", "id": "551c24bc-8859-4a83-b32b-1237329a7ffb", "active_ingredient": [ "Oral Analgesic (Maximum Strength) Active Ingredient Benzocaine 20%" ] }, { "effective_time": "20140214", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, GREEN 3 (CI 42053)" ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)" ], "warnings": [ "WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)" ], "spl_product_data_elements": [ "MARCS BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE FD&C GREEN NO. 3" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW" ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS" ], "set_id": "2673fffe-ba4d-427f-be0f-2127f6dbcb8c", "id": "cab8004b-b0eb-4d57-adcc-b3edf5fae46c", "active_ingredient": [ "ACTIVE INGREDIENTS EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20150330", "inactive_ingredient": [ "Inactive ingredients caramel color, citric acid, glycerin, propylene glycol, purified water, red raspberry flavor, saccharin sodium, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warning" ], "spl_product_data_elements": [ "Iophen NR guaifenesin GUAIFENESIN GUAIFENESIN CARAMEL CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL clear/light brown red raspberry" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with excessive phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions take every 4 hours do not take more than 6 doses in any 24-hour period adults and children 12 years and over take 10 to 20 mL (2 to 4 tsp) children 6 years to under 12 years take 5 to 10 mL (1 to 2 tsp) children 2 years to under 6 years take 2.5 to 5 mL (1/2 to 1 tsp) children under 2 years do not use Attention: Only use the measuring spoons or cups that are made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "spl_unclassified_section": [ "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev. 2/15 R5 8066055 1328" ], "storage_and_handling": [ "Other information each tsp contains: sodium 2 mg store at 15° to 30°C (59° to 86°F) You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811." ], "do_not_use": [ "Do not use in a child under 2 years of age" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is an image of the Iophen NR Liquid label." ], "indications_and_usage": [ "Use helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive" ], "set_id": "2696fb0e-f254-4677-b72a-dd49b750b01e", "id": "94078a95-0888-4263-adc0-1a6c80097f20", "active_ingredient": [ "Active ingredient (in each 5 mL = 1 tsp) Guaifenesin, USP 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 10 to 20 mL (2 to 4 tsp)
children 6 years to under 12 years take 5 to 10 mL (1 to 2 tsp)
children 2 years to under 6 years take 2.5 to 5 mL (1/2 to 1 tsp)
children under 2 years do not use
" ] }, { "effective_time": "20100607", "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive Ingredient: Purified water.", "Inactive ingredients flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose" ], "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Use: For preparation of skin before injection.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporary relief of minor aches, pains and headaches to reduce fever associated with colds, sore throats, teething" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only.", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product." ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Wipe Injection site vigorously and discard." ], "spl_product_data_elements": [ "ARC FIRST AID Contains 303 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL,BENZOCAINE,ALCOHOL, ASPIRIN,BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Chewable Aspirin ASPIRIN ASPIRIN ASPIRIN FD&C YELLOW NO. 6 SACCHARIN SODIUM CATION SILICON DIOXIDE STARCH, CORN STEARIC ACID SUCROSE ORANGE ASPIRIN Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B" ], "description": [ "LOT/EXP: Made in CHINA 20130301", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "LOT/EXP: Made in CHINA 20140301", "Made in CHINA LOT/EXP:", "MADE IN USA Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "ask_doctor": [ "Ask a doctor before use if you have; asthma stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems a child experiencing arthritis pain if you are; allergic to aspirin taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions Do not use more than directed Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours, Do not exceed 48 tablets in 24 hours unless directed by a doctor. Children Under 12 years: Consult a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and ask a doctor if; an allergic reaction occurs, Seek medical help right away pain or fever persists new or unexpected symptoms occur redness or swelling is present ringing in ears or loss of hearing occurs" ], "storage_and_handling": [ "Other Information: Store at room temperature", "Other information: Store at room temperature.", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Flammable - keep away from fire or flame.", "Store at room temperature tamper evident sealed packets do not use any opened or torn packets" ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: with electrocautery, in the eyes.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you are allergic to aspirin or any other pain relievers/fever reducers for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor for at least 7 days after a tonsillectomy or oral surgery" ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Antiseptic Towelette", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "GenuineTripleAntibiotic", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "GenuineEyeWash", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AlcoholCleansingPad", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "2 Tablets GENUINE FIRST AID. Chewable Aspirin 81mg", "Chewable Aspirin 81mg", "American Red Cross CONTAINS 303 PIECES FIRST AID KIT CLEAN . TREAT . PROTECT HOME PLAY AUTO OFFICE WORK All Purpose Kit NEW ORGANIZED POCKETS FOR EMERGENCY ACCESS SMALL CUTS AND BURNS 1 MEDIUM CUTS AND SCRATCHES 2 SEVERE BLEEDING AND BURNS 3 CAP BREATHING BARRIER 4 PROTECTION 5 INSTRUMENTS 6 AND EASY REFILL SYSTEM REFILL PACKS AVAILABLE FOR EACH POCKET Carrying Case 1 Soft-side Bag 1 Easy Access Pocket System Small Cuts and Burns 25 Adhesive Plastic Bandages 3/4\"x3\" 155 Junior Plastic Bandages 3/8\"x1-1/2\" 3 Adhesive Plastic Bandages 1\"x3\" 1 Knuckle Fabric Bandage 50 Adhesive Spot Bandages 7/8\"x7/8\" 1 Fingertip Fabric Bandage 1 Elbow/Knee Adhesive Bandage 1 Burn Cream 4 Antiseptic Towelettes 1 Triple Antibiotic Ointment 0.9gr 1 Sterile Gauze Pads 2\"x2\" 20 Cotton Tipped Applicators Medium Cuts and Scratches 4 Antiseptic Towelettes 1 Sterile Gauze Pad 2\"x2\" 1 Sterile Gauze Pad 3\"x3\" 1 Sterile Gauze Pad 4\"x4\" 1 Roller Gauze Bandage 2\"x4.1yds. 1 Sterile Eye Pad 1 Sterile Eye Wash 10ml 2 Butterfly Wound Closures Severe Bleeding and Burns 1 First Aid Tape Roll 1/2\"x2.5 yds. 1 Combine Pad 5\"x9\" 1 Combine Pad 8\"x10\" 1 Roller Gauze Bandage 3\"x4.1yds. CPR 1 CPR Breathing Barrier Protection 2 Medical Grade Vinyl Gloves 1 Instant Cold Compress 2 Alcohol Cleansing Pads 1 Insect Sting Relief Pads 1 Emergency Blanket 38\"x60\" 2 Chewable Aspirin Tablets 1 Triangular Bandage 42\"x42\"x59\" Instruments 1 Emergency First Aid Guide 1 Plastic Tweezers 1 Scissors 6 Assorted Safety Pins 2 Wooden Finger Splints Copyright 2009 Genuine First Aid LLC. All rights reserved. Manufactured in China for: Genuine First Aid LLC. 600 Cleveland Street Suite 400 Clearwater FL 33755 www.GenuineFirstAid.com GENUINE FIRST AID", "ARC Kit 303" ], "set_id": "27b0ee1b-0850-46b1-8822-7220ad014ea5", "id": "11272c2b-c459-4cae-9248-4646a532e736", "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID*). . . . . . . . . . . . . Analgesic/Antipyretic *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120711", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Enter section text here" ], "when_using": [ "When using this product, do not use more than directed." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: nasal decongestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever" ], "set_id": "28880f80-5d05-40a7-aaf0-0563c6f68c3a", "id": "f32e3302-f170-4be8-a351-8b383d43052d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredients(in each 15 ml tablespoon) Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg" ], "dosage_and_administration_table": [ "
adults and children 12 yrs and over 30 ml (2 TBSP) every 6 hours
children 6 to under 12 yrs 15 ml (1 TBSP) every 4 hours
children 4 to under 6 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients citric acid, FDC red no.40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucralose, sucrose, xanthan gum" ], "warnings": [ "Warnings Enter section text here Liver warning This product contains acetaminophen. Severe liver damage may occur if adult/child takes more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen(prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phegm(mucus) Persistent or chronic cough as occurs with smoking, asthma, emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Enter section text here Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms.", "Liver warning This product contains acetaminophen. Severe liver damage may occur if adult/child takes more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product", "Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly." ], "spl_product_data_elements": [ "Day Time Cold/Flu Relief Acetaminophen, Dextromethorphan, Phenylephrine ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SODIUM CITRATE SUCROSE SUCRALOSE SACCHARIN SODIUM DIHYDRATE XANTHAN GUM" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phegm(mucus) Persistent or chronic cough as occurs with smoking, asthma, emphysema a sodium-restricted diet" ], "other_safety_information": [ "Other information each tablespoon contains: sodium 50mg store at room temperature" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions take only as directed-see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 yrs and over 30 ml (2 TBSP) every 6 hours children 6 to under 12 yrs 15 ml (1 TBSP) every 4 hours children 4 to under 6 yrs ask a doctor children under 4 yrs do not use" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen(prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Daytime Cold/Flu Relief image of carton label" ], "overdosage": [ "Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20110826", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers increase drowsiness" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing" ], "set_id": "28b74efa-fbf4-4cc4-85e8-56807c773ee6", "id": "e1147c11-b7c7-4426-8dae-835da9205faa", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "dosage_and_administration_table": [ "
adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD and C blue no.1, FD and C yellow no.5, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "spl_product_data_elements": [ "Night Time Cold/Flu Relief Original Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ALCOHOL CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE SUCROSE SUCRALOSE DOXYLAMINE SUCCINATE DOXYLAMINE" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland" ], "other_safety_information": [ "Other information each 30 mL dose cup contains: sodium 43 mg store at room temperature" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hours adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "Package label Night Time Cold/Flu Relief Original image of bottle label" ], "overdosage": [ "Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20150501", "inactive_ingredient": [ "Inactive Ingredients flavor, glycerin, purified water, saccharin sodium, sodium benzoate" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "purpose": [ "Other Information 1 tablespoon contains: sodium 1668 mg this product is sugar-free this product usually causes a person to have a bowel movement in 30 minutes to 6 hours chill this product in refrigerator to improve the taste. Do not freeze" ], "warnings": [ "Warnings Taking more than the recommended dose in 24 hours can be harmful. Do not use if you have congestive heart failure if you have serious kidney problems in children under 5 years of age" ], "questions": [ "Questions? 1-888-999-9711 or www.phosphosoda.com" ], "spl_product_data_elements": [ "Fleet sodium phosphate, dibasic and sodium phosphate, monobasic SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE PHOSPHATE ION SODIUM CATION WATER GLYCERIN SACCHARIN SODIUM SODIUM BENZOATE SODIUM PHOSPHATE, MONOBASIC PHOSPHATE ION SODIUM CATION Ginger Lemon Flavor" ], "ask_doctor": [ "Ask a doctor before use if you are under a doctor's care for any medical condition on a low salt diet Ask a doctor or pharmacist before use if you are taking any other prescription or non-prescription drugs. Ask a doctor before using any laxative if you have abdominal (belly) pain, nausea, or vomitting a change in your daily bowel movements that lasts more than 2 weeks already used another laxative daily for constipation for more than 1 week" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Laxative Dose and Directions Ages (years) Step 1 Step 2 24 Hour Max Dose* 12 years & older Mix 1 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 3 tablespoons 10 to 11 years Mix 1 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 1 tablespoon 5 to 9 years Mix 1/2 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 1/2 tablespoon Under 5 years Do Not Use Do Not Use Do Not Use * Take no more than this amount in a 24 hour period. Use as a laxative for relief of occasional constipation. follow the dose and directions. do not take more unless directed by a doctor. See Warnings. drink as much extra liquids as you can to help replace the fluids you are losing during bowel movements." ], "stop_use": [ "Stop use and ask a doctor if you have any rectal bleeding do not have a bowel movement within 6 hours of taking this product have any symptoms that your body is losing more fluids than you are drinking. This is called dehydration. Early symptoms of dehydration include - feeling thristy - dizziness - urinating less often than normal - vomiting These symptoms may be signs of serious problems." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "Uses relief of occasional constipation to help clean out the bowel before medical procedures" ], "set_id": "2cc296be-6edc-40fe-98d9-121baa75eb4c", "id": "3472983d-129d-4f8d-8e46-de6eeebc63d8", "active_ingredient": [ "Active Ingredient (in each Tablespoon) Monobasic Sodium Phosphate 7.2 g.................Saline Laxative / Bowel Cleanser Dibasic Sodium Phosphate 2.7 g......................Saline Laxative / Bowel Cleanser" ], "dosage_and_administration_table": [ "
Laxative Dose and Directions
Ages (years) Step 1 Step 2 24 Hour Max Dose*
12 years & older Mix 1 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 3 tablespoons
10 to 11 years Mix 1 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 1 tablespoon
5 to 9 years Mix 1/2 tablespoon in a full glass of cold liquid (8 fl oz). Drink Drink at least 1 extra full glass of liquid (8 fl oz). 1/2 tablespoon
Under 5 years Do Not Use Do Not Use Do Not Use
" ] }, { "effective_time": "20140129", "drug_interactions": [ "Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction.", "Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.", "Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose.", "Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution.", "Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly." ], "geriatric_use": [ "Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "abuse": [ "Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence." ], "precautions": [ "PRECAUTIONS Animal reproduction studies have not been conducted with the drug combination-promethazine and codeine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine hydrochloride and codeine phosphate should be given to a pregnant woman only if clearly needed. General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Advise patients that some people have a genetic variation that results in codeine changing into morphine more rapidly and completely than other people. Most people are unaware of whether they are an ultra-rapid codeine metabolizer or not. These higher-than-normal levels of morphine in the blood may lead to life-threatening or fatal respiratory depression or signs of overdose such as extreme sleepiness, confusion, or shallow breathing. Children with this genetic variation who were prescribed codeine after tonsillectomy and/or adenoidectomy for obstructive sleep apnea may be at greatest risk based on reports of several deaths in this population due to respiratory depression. As a result, codeine is contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Advise caregivers of children receiving codeine for other reasons to monitor for signs of respiratory depression. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services). Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine. Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Promethazine was nonmutagenic in the Salmonella test system of Ames. Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown. Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine ). Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman. Pediatric Use: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( see WARNINGS – Box Warning and Use In Pediatric Patients ). Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in these patients (see WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine and CONTRAINDICATIONS ). The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see WARNINGS-Use in Pediatric Patients ). Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "description": [ "DESCRIPTION Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C 18 H 21 NO 3 •H 3 PO 4 •½H 2 O, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and the following structural formula: This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine.", "Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C 18 H 21 NO 3 •H 3 PO 4 •½H 2 O, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and the following structural formula: This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine." ], "labor_and_delivery": [ "Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown." ], "general_precautions": [ "General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP." ], "indications_and_usage": [ "INDICATIONS AND USAGE Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold." ], "dependence": [ "Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "set_id": "3150fc52-6a33-42f6-b08a-266146661a5f", "id": "bbb202cc-8929-4ad4-bb03-3737038a6e4e", "teratogenic_effects": [ "Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.", "Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known.", "Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." ], "pediatric_use": [ "Use In Pediatric Patients The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. The association does not directly relate to individualized weight-based dosing, which might otherwise permit safe administration. Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in these patients (see WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine and CONTRAINDICATIONS ). Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.", "Pediatric Use: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( see WARNINGS – Box Warning and Use In Pediatric Patients ). Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in these patients (see WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine and CONTRAINDICATIONS ). The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see WARNINGS-Use in Pediatric Patients )." ], "inactive_ingredient": [ "Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose." ], "contraindications": [ "CONTRAINDICATIONS The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. Codeine sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. Codeine is contraindicated in patients with a known hypersensitivity to the drug. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance. Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence. Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "warnings": [ "WARNINGS Respiratory Depression in Children The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Codeine: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine (see PRECAUTIONS -Nursing Mothers ). Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) (see OVERDOSAGE ). Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy (see CONTRAINDICATIONS ). When prescribing codeine-containing drugs, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose. Codeine : Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients. Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ). Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Respiratory Depression in Children The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Codeine: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine (see PRECAUTIONS -Nursing Mothers ). Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) (see OVERDOSAGE ). Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy (see CONTRAINDICATIONS ). When prescribing codeine-containing drugs, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose. Codeine : Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.", "Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function.", "Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ). Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ).", "Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.", "Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.", "Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents.", "Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Other Considerations Administration of promethazine has been associated with reported cholestatic jaundice." ], "pregnancy": [ "Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "nursing_mothers": [ "Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine ). Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman." ], "spl_product_data_elements": [ "Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate PROMETHAZINE HYDROCHLORIDE PROMETHAZINE CODEINE PHOSPHATE CODEINE ANHYDROUS ALCOHOL ASCORBIC ACID ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 3 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE grape blend flavor" ], "boxed_warning": [ "WARNING: Respiratory Depression in Children and Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory Depression in Children The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism." ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine.", "Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.", "Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine." ], "openfda": {}, "controlled_substance": [ "Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance." ], "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. It is important that promethazine with codeine syrup is measured with an accurate measuring device (see PRECAUTIONS-Information For Patients ). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. The average effective dose for adults and children 12 years of age and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours. The average effective dose for children 6 years to under 12 years of age is 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours." ], "adverse_reactions": [ "ADVERSE REACTIONS Codeine: Nervous System – CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions. Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics). Gastrointestinal – Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported. Genitourinary – Oliguria, urinary retention; antidiuretic effect has been reported (common to narcotic analgesics). Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema. Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness. Promethazine: Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported. Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic – Dermatitis, photosensitivity, urticaria. Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Gastrointestinal – Dry mouth, nausea, vomiting, jaundice. Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS - Promethazine; Respiratory Depression .) Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS - Promethazine; Neuroleptic Malignant Syndrome .) Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCI. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients." ], "spl_unclassified_section": [ "CV Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880 8181652 R2/13-R5" ], "how_supplied": [ "HOW SUPPLIED Promethazine with Codeine Syrup, a clear purple syrup with odor of grape menthol, contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL)." ], "information_for_patients": [ "Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Advise patients that some people have a genetic variation that results in codeine changing into morphine more rapidly and completely than other people. Most people are unaware of whether they are an ultra-rapid codeine metabolizer or not. These higher-than-normal levels of morphine in the blood may lead to life-threatening or fatal respiratory depression or signs of overdose such as extreme sleepiness, confusion, or shallow breathing. Children with this genetic variation who were prescribed codeine after tonsillectomy and/or adenoidectomy for obstructive sleep apnea may be at greatest risk based on reports of several deaths in this population due to respiratory depression. As a result, codeine is contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Advise caregivers of children receiving codeine for other reasons to monitor for signs of respiratory depression. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL IMAGE LABEL" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours. Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.", "Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours.", "Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Promethazine was nonmutagenic in the Salmonella test system of Ames." ], "nonteratogenic_effects": [ "Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "overdosage": [ "OVERDOSAGE Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates. Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur. Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful.", "Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates.", "Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur.", "Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful." ] }, { "effective_time": "20150409", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, GREEN 3 (CI 42053)" ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT DO NOT SWALLOW" ], "questions": [ "QUESTIONS OR COMMENTS? 1-800-289-8343" ], "spl_product_data_elements": [ "HYVEE ANTISEPTIC BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE FD&C GREEN NO. 3" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT DO NOT SWALLOW", "DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS, WITH 20 ML (2/3 FLUID OUNCES OR 4 TEASPOONFULS) MORNING AND NIGHT DO NOT SWALLOW" ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE AND PREVENT PLAQUE GINGIVITIS" ], "set_id": "31568a08-bfc8-4ffd-9a86-75c006db327f", "id": "bf9105a3-4bed-4b02-92d3-9b0354528cbc", "active_ingredient": [ "ACTIVE INGREDIENTS EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20090505", "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C blue no. 1, FD&C red no. 40, grape flavor, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use in a child under 6 years of age Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions 888-974-5279 †This product is not manufactured or distributed by Wyeth Consumer Healthcare owner of the registered trademark Dimetapp®. Manufactured by: Silarx Pharmaceuticals, Inc 19 West Street Spring Valley, NY 10977 USA Rev. 3/09" ], "spl_product_data_elements": [ "Brotapp PE Liquid Brotapp PE Liquid Brompheniramine maleate Brompheniramine Phenylephrine hydrochloride Phenylephrine anhydrous citric acid FD&C blue no. 1 FD&C red no. 40 propylene glycol saccharin sodium sodium benzoate sodium citrate sorbitol water grape flavor" ], "description": [ "Drug Facts Active ingredients (in each 5 mL) Purpose Brompheniramine maleate 1 mg . . . . . . . . . . . . . . . . . . . . . . . Antihistamine Phenylephrine hydrochloride 2.5 mg . . . . . . . . . . . . . . . . . . . . Nasal Decongestant" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland breathing problem such as emphysema or chronic bronchitis" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than 6 doses in any 24-hour period Adults and children 12 years and over 4 teaspoonfuls every 4 hours Children 6 to under 12 years 2 teaspoonfuls every 4 hours Children under 6 years DO NOT USE Other information Store at 20°-25°C (68°-77°F)." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Container Label 118 mL Container Label 237 mL Container Label 473mL" ], "indications_and_usage": [ "Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose" ], "set_id": "31b37d40-0856-42c1-bb6b-20c8c8a12cd9", "id": "1e7a7b57-56b8-4858-80b9-a0afef5d987c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "dosage_and_administration_table": [ "
Adults and children 12 years and over 4 teaspoonfuls every 4 hours
Children 6 to under 12 years 2 teaspoonfuls every 4 hours
Children under 6 years DO NOT USE
" ] }, { "effective_time": "20120410", "inactive_ingredient": [ "Inactive ingredients water,sodium saccharin, sodium hydroxide,hydrogenated castor oil, triclosan." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "purpose": [ "Purpose Mouthwash that aids in the prevention of dental cavities" ], "warnings": [ "Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "NATURES SMILE SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SACCHARIN SODIUM SODIUM HYDROXIDE WATER TRICLOSAN HYDROGENATED CASTOR OIL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "." ], "package_label_principal_display_panel": [ "image front and back of bottle" ], "indications_and_usage": [ "Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or doctor instruct children under 6 years in good brushing and rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 2 years ask a dentist or physician" ], "set_id": "32d0071a-b16e-4450-9528-88a78847dc08", "id": "8fa43213-34bb-4291-9560-ed59d4daf16b", "active_ingredient": [ "Active ingredients Sodium monofluorophosphate (0.84%) Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Purpose Mouthwash that aids in the prevention of dental cavities Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Inactive ingredients water,sodium saccharin, sodium hydroxide,hydrogenated castor oil, triclosan. Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or doctor instruct children under 6 years in good brushing and rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 2 years ask a dentist or physician ." ] }, { "effective_time": "20080825", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Sorbitol, Silica, Treated Water (Aqua), Glycerin, Polyethylene Glycol 1500, Sodium Lauryl Sulphate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, Methylparaben, Propylparaben, Color: FD & C Blue # 1." ], "purpose": [ "PURPOSE: Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately." ], "warnings": [ "WARNINGS: Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Freshmint Premium Anticavity SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL SILICON DIOXIDE WATER GLYCERIN POLYETHYLENE GLYCOL 1500 SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE SACCHARIN SODIUM DIHYDRATE SODIUM BENZOATE SODIUM PYROPHOSPHATE METHYLPARABEN PROPYLPARABEN FD&C BLUE NO. 1 MINT" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS: Adults and children 2 years & older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. To minimize swallowing use a pea-sized amount in children under 6 years of age. Supervise children's brushing until good habits are established. Children under 2 years: Ask a dentist." ], "spl_unclassified_section": [ "Drug Facts" ], "package_label_principal_display_panel": [ "Principal Display Panel – Tube Label ADA Accepted American Dental Association ® freshmint ® Premium Anticavity Toothpaste NET WT. 3.0 oz Principal Display Panel – Tube Label" ], "indications_and_usage": [ "USES: Helps protect teeth and roots against cavities." ], "set_id": "3374e95d-47f0-48c9-b2d6-563d37766cf6", "id": "20358bd8-39b8-41a7-a0cd-dbf27e4e0a61", "active_ingredient": [ "ACTIVE INGREDIENT: Sodium Fluoride - 0.243% (0.15% w/v fluoride ion)" ] }, { "effective_time": "20120711", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: runny nose and sneezing cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever" ], "set_id": "36263ccb-c5b2-42e0-bc16-b4b4000671bc", "id": "649e7b4c-23a5-4b95-8947-6a0afaa3701c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each 30 ml dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD and C blue no.1, FD and C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose, xanthan gum" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "spl_product_data_elements": [ "Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ALCOHOL CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SACCHARIN SODIUM DIHYDRATE SODIUM CITRATE SUCROSE SUCRALOSE DOXYLAMINE SUCCINATE DOXYLAMINE XANTHAN GUM" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet" ], "other_safety_information": [ "Other information each 30 mL dose cup contains : sodium 43 mg store at room temperature" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "Package label Night Time Cold/Flu Relief Cherry image of bottle label" ], "overdosage": [ "Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20100108", "drug_interactions": [ "Drug Interactions Beta adrenergic blockers and MAOIs may potentiate the pressor effect of phenylephrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias. Do not prescribe this product for use in patients that are now taking a prescription MAOI (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 14 days after stopping MAOI drug therapy." ], "geriatric_use": [ "Geriatric Use Patients aged 60 and older are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and death. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or drug therapy." ], "precautions": [ "PRECAUTIONS Information for Patients Patient consultation should include the following information regarding proper use of this medication: • Do not take more medication than the amount recommended. • Do not take MAOIs while taking this medication. • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; not doubling doses. • This medication should be stored in a tight, light-resistant container at temperatures between 20°- 25°C (68°- 77°F), see USP Controlled Room Temperature. • Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Drug Interactions Beta adrenergic blockers and MAOIs may potentiate the pressor effect of phenylephrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias. Do not prescribe this product for use in patients that are now taking a prescription MAOI (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 14 days after stopping MAOI drug therapy. Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals and humans. Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This product should be used during pregnancy only if the potential benefits to the mother justify the potential risks to the infant. Nursing Mothers Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers. Pediatric Use Safety and effectiveness of this product in pediatric patients below the age of 6 years have not been established. Very young children may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines like phenylephrine. Geriatric Use Patients aged 60 and older are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and death. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or drug therapy." ], "description": [ "DESCRIPTION Each teaspoonful (5mL) contains: Carbetapentane Citrate . . . . . . . . . . . . . 30 mg Phenylephrine HCl . . . . . 10 mg Brompheniramine Maleate . . . . . . . . . . . . . 6 mg" ], "storage_and_handling": [ "Storage and Handling Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. Store at controlled room temperature, 20°- 25°C (68°- 77°F), See USP Controlled Room Temperature. Call Your Doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088. Rx Only Manufactured for: Capellon Pharmaceuticals, LLC Fort Worth, TX 76118 500391 Rev. 09/09" ], "indications_and_usage": [ "INDICATIONS AND USAGE For the temporary relief of symptoms associated with the common cold, allergies, hay fever, sinusitis, influenza, bronchitis and other respiratory illnesses. Relieves cough due to throat and bronchial irritation as may occur with the common cold, inhaled irritants, or related conditions." ], "set_id": "3734ea65-1c6d-4a85-9472-0f8a712683b4", "id": "1be84d03-4892-435a-8247-fa862138881a", "pediatric_use": [ "Pediatric Use Safety and effectiveness of this product in pediatric patients below the age of 6 years have not been established. Very young children may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines like phenylephrine." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS benzoic acid, bubblegum flavor, citric acid, edetate disodium USP, glycerin, propylene glycol, purified water, saccharin sodium, sodium citrate dihydrate and sorbitol. Carbetapentane Citrate is an antitussive which occurs as a white crystalline powder. It is freely soluble in water, chloroform; soluble in alcohol, acetone, ethyl acetate. It is practically insoluble in ether, petr ether, benzene. The chemical name is 1-Phenylcyclopentanecarboxylic Acid 2-(2-Diethylaminoethoxy)ethyl Ester Citrate Salt. The chemical structure of Carbetapentane Citrate is as follows: C 20 H 31 NO 3 • C 6 H 8 O 7 M.W. 525.59 Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically it is (R)-3-hydroxy-α-[(methylamino)methyl]benzenemethanol hydrochloride and has the following structural formula: C 9 H 13 NO 2 • HCI M.W. 203.67 Brompheniramine maleate is an antihistamine having the chemical name, 2-Pyridinepropanamine, γ-(4-bromophenyl)- N,N -dimethyl-, (±)-,(Z)-2-butenedioate (1:1) The chemical structure of Brompheniramine Maleate is as follows: C 16 H 19 BrN 2 • C 4 H 4 O 4 M.W. 435.31" ], "contraindications": [ "CONTRAINDICATIONS Trexbrom( Liquid is contraindicated in patients hypersensitive to any of its ingredients. It is also contraindicated in patients with severe hypertension or severe coronary artery disease, or in those receiving monoamine oxidase inhibitor (MAOI) therapy. Antihistamines should not be used to treat lower respiratory tract conditions including asthma." ], "warnings": [ "WARNINGS Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. DO NOT EXCEED RECOMMENDED DOSAGE ." ], "pregnancy": [ "Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This product should be used during pregnancy only if the potential benefits to the mother justify the potential risks to the infant." ], "nursing_mothers": [ "Nursing Mothers Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers." ], "spl_product_data_elements": [ "Trexbrom Carbetapentane Citrate / Phenylephrine HCl / Brompheniramine Maleate PENTOXYVERINE CITRATE PENTOXYVERINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BROMPHENIRAMINE MALEATE BROMPHENIRAMINE BENZOIC ACID CITRIC ACID MONOHYDRATE EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE SORBITOL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults and children 12 years and older: 1 teaspoon (5 mL). Children 6 to 12 years of age: 1/2 teaspoon (2.5 mL). May be repeated every 6 hours as required for relief. Not to exceed 4 doses in 24 hours. In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate." ], "adverse_reactions": [ "ADVERSE REACTIONS Mild central nervous system stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs, may occur. Nervousness, excitability, restlessness, dizziness, weakness, and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause lightheadedness, nausea, and/or vomiting. Sympathomimetic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, pallor, respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias, and cardiovascular collapse with hypotension." ], "how_supplied": [ "HOW SUPPLIED Trexbrom( Liquid is a clear, sugar free, alcohol free, bubble gum flavored liquid. Available in 10 mL sample bottles (NDC 64543-500-10), 4 oz. Bottles (NDC 64543-500-04), and 16 oz. Bottles (NDC 64543-500-16). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Storage and Handling Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. Store at controlled room temperature, 20°- 25°C (68°- 77°F), See USP Controlled Room Temperature. Call Your Doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088. Rx Only Manufactured for: Capellon Pharmaceuticals, LLC Fort Worth, TX 76118 500391 Rev. 09/09" ], "information_for_patients": [ "Information for Patients Patient consultation should include the following information regarding proper use of this medication: • Do not take more medication than the amount recommended. • Do not take MAOIs while taking this medication. • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; not doubling doses. • This medication should be stored in a tight, light-resistant container at temperatures between 20°- 25°C (68°- 77°F), see USP Controlled Room Temperature. • Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 1: Trexbrom 10 mL sample label Figure 2: Trexbrom 4 oz product label Figure 3: Trexbrom 16 oz. product label 1be84d03-figure-01 1be84d03-figure-02 1be84d03-figure-03 1be84d03-figure-04 1be84d03-figure-05 1be84d03-figure-06" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Carbetapentane Citrate is a centrally acting non-narcotic antitussive agent with mild atropine-like antisecretory activity; used in the treatment of cough associated with upper respiratory infections. Phenylephrine Hydrochloride is a nasal decongestant, and a potent postsynaptic alpha (α)-receptor agonist with little effect on the beta (β)-receptors of the heart. Phenylephrine HCl has no effect on the (β)-adrenergic receptors of the bronchi or peripheral blood vessels. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Therapeutic doses of phenylephrine HCl may cause vasoconstriction. It increases resistance and, to a lesser extent, decreases the capacitance of blood vessels. Total peripheral resistance is increased, resulting in increased systolic and diastolic blood pressure. Pulmonary arterial pressure is usually increased, and renal blood flow is usually decreased. Local vasoconstriction and hemostasis occur following infiltration of phenylephrine HCl into tissues. The main effect of phenylephrine HCl on the heart is bradycardia; it produces a positive inotropic effect on the myocardium in doses greater than those usually used therapeutically. Rarely, the drug may increase the irritability of the heart which can cause arrhythmias. Cardiac output is decreased slightly. Phenylephrine HCl increases the work of the heart by increasing peripheral arterial resistance. Phenylephrine HCl has a mild central stimulant effect. Following oral administration of phenylephrine HCl, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. Brompheniramine Maleate is classified as an alkylamine antihistamine. This class is among the most active histamine antagonists and is generally effective in relatively low milligram doses. Alkylamines cause a lesser degree of drowsiness and sedation than the phenothiazine antihistamines and hence may be more suitable for daytime use. It should be noted, however, that patients taking alkylamine antihistamines may experience some degree of drowsiness." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals and humans." ], "overdosage": [ "OVERDOSAGE Signs and Symptoms: Central effects include restlessness, dizziness, tremor, hyper-reactive reflexes, talkativeness, irritability, and insomnia. Cardiovascular and renal effects include difficulty in urination, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, anorexia, nausea, vomiting, diarrhea, and abdominal cramps. Recommended Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method; however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administrated as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive." ] }, { "effective_time": "20121105", "inactive_ingredient": [ "Inactive ingredients Ginger lemon flavor, glycerin, purified water, saccharin sodium, sodium benzoate" ], "purpose": [ "Purpose Saline laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Dosage warning Taking more than the recommended dose in 24 hours can be harmful. Do not use if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities in children under 5 years of age for bowel cleansing Ask a doctor before use if you have abdominal pain, nausea, or vomiting kidney disease heart problems a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than a week a dehydration condition Ask a doctor or pharmacist before use if you are on a sodium restricted diet under a doctor’s care for any medical condition taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. Stop use and ask a doctor if you have any rectal bleeding do not have a bowel movement within 6 hours have any symptoms that your body is losing more fluid than you are drinking have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting. These symptoms may indicate a serious condition. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "questions": [ "Questions 1-800-633-5463" ], "spl_product_data_elements": [ "Oral Saline Laxative Ginger Lemon dibasic sodium phosphate, monobasic sodium phosphate SODIUM PHOSPHATE, DIBASIC PHOSPHATE ION SODIUM PHOSPHATE, MONOBASIC PHOSPHATE ION GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain, nausea, or vomiting kidney disease heart problems a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than a week a dehydration condition" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use as a laxative for relief of occasional constipation dilute dose in the table below with one glass (8 fl. oz.) cool water. Drink, then follow with at least one additional glass (8 fl. oz.) cool water. There is significant loss of liquid when using this product. To prevent dehydration drink plenty of clear liquid after use. Do not use for bowel cleansing. Do not take more unless directed by a doctor. See Warning. There are three Teaspoons in one Tablespoon. Ages (Years) Dosage Maximum Dose 12 & Older 3 Teaspoons 6 or 9 Teaspoons* 10 & 11 3 Teaspoons* 3 Teaspoons* 5 to 9 1 1/2 Teaspoons* 1 1/2 Teaspoons* under 5 Do Not Use Do Not Use *SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have any rectal bleeding do not have a bowel movement within 6 hours have any symptoms that your body is losing more fluid than you are drinking have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting. These symptoms may indicate a serious condition." ], "storage_and_handling": [ "Other information Each Teaspoon contains: sodium 556 mg Saline laxatives increase retention of water in the intestine, promoting bowel movements. this product generally produces a bowel movement in 30 minutes to 6 hours this product is sugar free do not freeze store at room temperature TAMPER EVIDENT: Mouth of bottle sealed for your safety. If foil seal is missing or broken, do not use." ], "do_not_use": [ "Do not use if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities in children under 5 years of age for bowel cleansing" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel sunmark NDC 49348-111-12 Oral Saline Laxative Sugar Free For relief of occasional constipation Single dose container GINGER LEMON FLAVOR 1.5 FL OZ (45 mL) Sunmark Oral Saline Laxative Ginger Lemon Principal Display Panel", "Package Drug Facts 1 Sunmark Oral Saline Laxative Ginger Lemon Drug Facts", "Package Drug Facts 2 Sunmark Oral Saline Laxative Ginger Lemon Drug Facts continued" ], "indications_and_usage": [ "Use for relief of occasional constipation" ], "set_id": "37d2d0d2-ed3d-485e-be10-6c29c509e678", "id": "37d2d0d2-ed3d-485e-be10-6c29c509e678", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are on a sodium restricted diet under a doctor’s care for any medical condition taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient (in each tablespoon) Dibasic sodium phosphate 2.7 g Monobasic sodium phosphate 7.2 g" ], "dosage_and_administration_table": [ "
Ages (Years) Dosage Maximum Dose
12 & Older 3 Teaspoons 6 or 9 Teaspoons*
10 & 11 3 Teaspoons* 3 Teaspoons*
5 to 9 1 1/2 Teaspoons* 1 1/2 Teaspoons*
under 5 Do Not Use Do Not Use
" ] }, { "effective_time": "20130917", "inactive_ingredient": [ "INACTIVE INGREDIENTS: WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 5, BLUE 1" ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "warnings": [ "WARNINGS DO NOT USE IF YOU HAVE PAINFUL OR SWOLLEN GUM LINE, LOOSE TEETH OR INCREASED SPACING BETWEEN THE TEETH. SEE YOUR DENTIST IMMEDIATELY. THESE MAY BE SIGNS OF PERIODONTITIS, A SERIOUS FORM OF GUM DISEASE. DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE. STOP USE AND ASK A DENTIST IF GINGIVITIS, BLEEDING OR REDNESS PERSISTS FOR MORE THAN 72 HOURS. KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "spl_product_data_elements": [ "Royal Mouthwash Fresh and Clean Original Mint EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE FD&C YELLOW NO. 5 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER. VIGOROUSLY SWISH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) BETWEEN TEETH FOR 30 SECONDS THEN SPI9T OUT;DO NOT SWALLOW. CHILDREN UNDER 12 YEARS OF AGE, CONSULT A DENTIST OR DOCTOR. THIS RINSE IS NOT INTENDED TO REPLACE BRUSHING OR FLOSSING." ], "storage_and_handling": [ "OTHER INFORMATION COLD WATER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED. STORE AT ROOM TEMPERATURE (59°-77°F)." ], "package_label_principal_display_panel": [ "image of label" ], "indications_and_usage": [ "USES TO HELP CONTROL PLAQUE THAT LEADS TO GINGIVITIS." ], "set_id": "3830dc3a-98f7-4b56-b3ae-281bb24e2e1f", "id": "1dd6b65e-11df-4ec2-93af-70888a53b1b1", "active_ingredient": [ "ACTIVE INGREDIENT EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20100618", "purpose": [ "Active ingredients (in each 15 ml tablespoon) Purpose Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCl 10 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product, do not take more than directed." ], "questions": [ "Questions? 1-800-342-6844" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains sodium 35 mg store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves these cold symptoms cough nasal congestion" ], "set_id": "39827a87-1622-457e-88fe-7d0fe5d778f3", "id": "67e180a3-61f2-4d61-8e77-1df714276d22", "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Purpose Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCl 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 TBSP (15 ml) every 4 hours
children 6 to under 12 years 1½ tsp (7½ ml) every 4 hours
children under 6 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, carboxymethylcellulose sodium, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, sucrose" ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease diabetes high blood pressure cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet When using this product, do not take more than directed. Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Vicks 44 D Dextromethorphan Hydrobromide and Phenylephrine Dextromethorphan Hydrobromide Dextromethorphan Phenylephrine Phenylephrine" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease diabetes high blood pressure cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use dose cup, teaspoon (tsp), or tablespoon (TBSP) do not exceed 6 doses per 24 hours adults and children 12 years and over 1 TBSP (15 ml) every 4 hours children 6 to under 12 years 1½ tsp (7½ ml) every 4 hours children under 6 years ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "www.vicks.com Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each 15 ml tablespoon) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Phenylephrine HCl 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 ml bottle label NON- DROWSY VICKS ® FORMULA 44 D DECONGESTANT Cough & Head Congestion Relief Cough Suppressant...Nasal Decongestant 4 FL OZ (118 ml) Alcohol 5% Principal Display Panel - 118 ml bottle label" ], "purpose_table": [ "
Active ingredients (in each 15 ml tablespoon) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Phenylephrine HCl 10 mg Nasal decongestant
" ] }, { "effective_time": "20121105", "inactive_ingredient": [ "Inactive ingredients cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum" ], "purpose": [ "Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact aids in the prevention of dental cavities" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "HyVee Maximum Strength Fluoride SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION WATER SACCHARIN SODIUM SODIUM TRIPOLYPHOSPHATE POLYETHYLENE GLYCOL 400 SORBITOL TITANIUM DIOXIDE SODIUM HYDROXIDE GLYCERIN XANTHAN GUM HYDRATED SILICA COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE mint" ], "other_safety_information": [ "Other Information Store in a cool dry place. Keep tube capped when not in use." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor." ], "package_label_principal_display_panel": [ "mm1.jpg mm2.jpg Carton label Tube Label" ], "indications_and_usage": [ "Directions Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth." ], "set_id": "3a50a833-2a3d-4d08-98f2-d442cf62715b", "id": "de6ff268-a67c-4c47-977d-363312ce64af", "active_ingredient": [ "Active ingredients / Purpose Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity" ] }, { "effective_time": "20150306", "inactive_ingredient": [ "Inactive ingredients citric acid, flavor, menthol racemic, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol" ], "purpose": [ "Purpose Cough suppressant Nasal decongestant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Drug interaction precaution. Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product." ], "when_using": [ "When using this product do not exceed recommended dosage you may get drowsy alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "spl_product_data_elements": [ "Codituss DM dextromethorphan hydrobromide and phenylephrine hydrochloride and pyrilamine maleate DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PYRILAMINE MALEATE PYRILAMINE ANHYDROUS CITRIC ACID MENTHOL PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SORBITOL cherry menthol" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty urinating due to enlargement of the prostate gland a persistent or chronic cough such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus) heart disease, high blood pressure, thyroid disease, or diabetes" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not exceed 6 doses in 24 hours adults and children 12 years and over 2 teaspoonfuls every 4 hours, or as directed by a physician children 6 years to under 12 years 1 teaspoonful every 4 hours, or as directed by a physician children under 6 years consult a physician" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if symptoms do not improve within 7 days, or are accompanied by fever nervousness, dizziness, or sleeplessness occur cough persists for more than one week, tends to recur or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition." ], "spl_unclassified_section": [ "Other information Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature].", "Made in the USA for Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811 Rev. 2/15 R5 8062012 0728" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is the front and back of the Codituss DM 4oz label" ], "indications_and_usage": [ "Uses temporarily suppresses cough associated with the common cold or inhaled irritant(s) temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies" ], "set_id": "3b5ca328-d462-490d-a28d-8a1a47299668", "id": "3cf56b16-2207-415e-8b80-1664dbd42b55", "ask_doctor_or_pharmacist": [ "Ask a doctor or a pharmacist before use if you are taking sedatives or tranquilizers. Ask a doctor before giving to children who are taking other drugs." ], "active_ingredient": [ "Active ingredients (in each 5 mL = 1 tsp) Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Pyrilamine maleate 8.33 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 teaspoonfuls every 4 hours, or as directed by a physician
children 6 years to under 12 years 1 teaspoonful every 4 hours, or as directed by a physician
children under 6 years consult a physician
" ] }, { "effective_time": "20121015", "inactive_ingredient": [ "Inactive ingredients citric acid, flavors, purified water, red 40, saccharin sodium, sodium bicarbonate" ], "purpose": [ "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately" ], "warnings": [ "Warnings Ask a doctor before use if you have kidney disease a magnesium restricted diet a sodium restricted diet stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 1 week. Ask a doctor or pharmacist before use if you are presently taking a prescription drug When using this product do not exceed the maximum recommended daily dosage in a 24 hour period" ], "questions": [ "Questions or comments? (305) 382-3288 Gadal Laboratories Inc Miami Fl 33186" ], "spl_product_data_elements": [ "Gadavyt Magnesium Citrate MAGNESIUM CITRATE MAGNESIUM CATION CITRIC ACID MONOHYDRATE FD&C RED NO. 40 SACCHARIN SODIUM DIHYDRATE WATER SODIUM BICARBONATE Cherry" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years of age and older 1/2 to 1 bottle (10 fl. oz.) Drink a full 8 oz glass of liquid with each dose. These dose may be taken as a single daily dose or in divided doses children 6 to under 12 years of age 1/3 to 1/2 bottle with a fill 8 oz glass of liquid children under 6 years of age consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use." ], "do_not_use": [ "Stop use and ask a doctor if you have rectal bleeding or no bowel movement after use. These could be signs of a serious condition you need to use a laxative for more than 1 week" ], "package_label_principal_display_panel": [ "magcitcherry" ], "indications_and_usage": [ "Other information each fluid once contains: sodium 36 mg, magnesium 199 mg store at room temperature protect from excessive heat and freezing discard unused product within 24 hours of opening" ], "set_id": "3b94301b-8f2c-41c7-b5b3-e0b53d69c2d3", "id": "64688b81-89cb-42bc-a7fe-8491b179911e", "active_ingredient": [ "Active Ingredient Purpose Magnesium citrate 1.745g per fl. Oz...... Saline Laxative Uses relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and older 1/2 to 1 bottle (10 fl. oz.) Drink a full 8 oz glass of liquid with each dose. These dose may be taken as a single daily dose or in divided doses
children 6 to under 12 years of age 1/3 to 1/2 bottle with a fill 8 oz glass of liquid
children under 6 years of age consult a doctor
" ] }, { "effective_time": "20120215", "inactive_ingredient": [ "Inactive ingredients alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Cough suppressant Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product constipation may occur or be aggravated" ], "spl_product_data_elements": [ "Cheratussin AC codeine phosphate and guaifenesin CODEINE PHOSPHATE CODEINE GUAIFENESIN GUAIFENESIN ALCOHOL CARAMEL CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN MENTHOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with excessive phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take every 4 hours do not take more than 6 doses in any 24-hour period adults and children 12 years and over take 10 mL (2 tsp) children 6 years to under 12 years take 5 mL (1 tsp) children 2 years to under 6 years consult a doctor children under 2 years do not use Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "spl_unclassified_section": [ "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev. 11/09 R6 8081202 1075" ], "storage_and_handling": [ "Other information store at 15° to 30°C (59° to 86°F) You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811 ." ], "do_not_use": [ "Do not use in a child under 2 years of age if you or your child has a chronic pulmonary disease or shortness of breath if your child is taking other drugs, unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 55045-1495-09 NDC 55045-1495-09" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive calms the cough control center and relieves coughing" ], "set_id": "3c1b7544-cc9e-43a4-ab3a-dd410af6cd56", "id": "34c0ab0b-2de8-4be7-a600-a7fb67e08b9b", "active_ingredient": [ "Active ingredients (in each 5 mL = 1 tsp) Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 10 mL (2 tsp)
children 6 years to under 12 years take 5 mL (1 tsp)
children 2 years to under 6 years consult a doctor
children under 2 years do not use
" ] }, { "effective_time": "20151111", "drug_interactions": [ "Drug Interactions The use of codeine may result in additive CNS depressant effects when co administered with alcohol, antihistamines, psychotropics, or other drugs which produce CNS depression." ], "precautions": [ "PRECAUTIONS General Ultra-rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regiments, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose. (See PRECAUTIONS-Nursing Mothers .) Information for Patients Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby’s doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services). Drug Interactions The use of codeine may result in additive CNS depressant effects when co administered with alcohol, antihistamines, psychotropics, or other drugs which produce CNS depression. Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies of ExeClear-C Syrup to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed. Pregnancy Teratogenic Effects Pregnancy-Category C: Teratogenic Effects: Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, this product should not be used in pregnant patients unless, in the judgment of the physician, the potential benefits outweigh possible hazards. Nonteratogenic Effects Nonteratogenic Effects: Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyper-reflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Labor and Delivery Labor and Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required. Nursing Mothers Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine’s active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. (See PRECAUTIONS - General - Ultra-rapid Metabolizers of Codeine . ) DRUG & OR LABORATORY TEST INTERACTIONS Laboratory Test Interactions: Guaifenesin or its metabolites may cause color interference with the vanillylmandelic acid (VMA) test for catechols. It may also falsely elevate the level of urinary 5-hydroxyindoleacetic acid (5-HIAA) in certain serotonin metabolite chemical tests because of color interference." ], "description": [ "DESCRIPTION ExeClear-C Syrup is a clear, colorless liquid with a fruit gum flavor for oral administration. Each teaspoon (5 ml) of ExeClear-C Syrup contains: Codeine* Phosphate USP …………………. 10 mg (*Warning: May be habit Forming) Guaifenesin USP ………………………………. 200 mg Codeine phosphate has the chemical name 7, 8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Its molecular formula is C 18 H 21 NO 3 H 3 PO 4 • ½H 2 O with a molecular weight of 406.37. It occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is freely soluble in water at 25°C; slightly soluble in ethanol. Following absorption codeine is metabolized by the liver and metabolic products are excreted in the urine. Its structure is as follows: Guaifenesin has the chemical name 3-(2-methoxyphenoxy)-1,2-propanediol. Its molecular formula is C 10 H 14 O 4 , with a molecular weight of 198.21. It is a white or slightly gray crystalline substance with a slightly bitter aromatic taste. One gram dissolves in 20 mL water at 25°C; freely soluble in ethanol. Guaifenesin is readily absorbed from the GI tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is beta-(2-methoxyphenoxy) lactic acid. Its structure is as follows: 5e470c5c-figure-01 5e470c5c-figure-02" ], "labor_and_delivery": [ "Labor and Delivery Labor and Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required." ], "general_precautions": [ "General Ultra-rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regiments, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose. (See PRECAUTIONS-Nursing Mothers .)" ], "storage_and_handling": [ "Storage and Handling Storage - Store at controlled room temperature - 15°-30°C (59°-86°F). Protect from light. Keep bottle tightly closed. Distributed by: Larken Laboratories, Inc. Madison, MS 39110 Questions or Comments: 888-527-5522 Manufactured by: Deltex Pharmaceuticals, Inc. Rosenburg, TX 77471 Rev. 09/08" ], "indications_and_usage": [ "INDICATIONS AND USAGE Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Calms the cough control center and relieves coughing. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive." ], "set_id": "3c1bb39e-4b4f-4c51-8908-12d5880bde57", "id": "244633df-2bcc-34ed-e054-00144ff8d46c", "teratogenic_effects": [ "Teratogenic Effects Pregnancy-Category C: Teratogenic Effects: Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, this product should not be used in pregnant patients unless, in the judgment of the physician, the potential benefits outweigh possible hazards." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Propylene glycol, Glycerin, Sodium benzoate, Citric acid, Saccharin sodium, Magnasweet, Flavor, Sorbitol, and Purified water." ], "contraindications": [ "CONTRAINDICATIONS Hypersensitivity to any of the ingredients." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Controlled Substance - Schedule V Dependence - Codeine may be habit forming." ], "pregnancy": [ "Pregnancy Teratogenic Effects Pregnancy-Category C: Teratogenic Effects: Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, this product should not be used in pregnant patients unless, in the judgment of the physician, the potential benefits outweigh possible hazards. Nonteratogenic Effects Nonteratogenic Effects: Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyper-reflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life." ], "nursing_mothers": [ "Nursing Mothers Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine’s active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. (See PRECAUTIONS - General - Ultra-rapid Metabolizers of Codeine . )" ], "spl_product_data_elements": [ "ExeClear C Codeine Phosphate / Guaifenesin CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL SACCHARIN SODIUM SODIUM BENZOATE SORBITOL WATER GLYCYRRHIZIN, AMMONIATED CODEINE PHOSPHATE CODEINE ANHYDROUS GUAIFENESIN GUAIFENESIN" ], "drug_and_or_laboratory_test_interactions": [ "DRUG & OR LABORATORY TEST INTERACTIONS Laboratory Test Interactions: Guaifenesin or its metabolites may cause color interference with the vanillylmandelic acid (VMA) test for catechols. It may also falsely elevate the level of urinary 5-hydroxyindoleacetic acid (5-HIAA) in certain serotonin metabolite chemical tests because of color interference." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults and children 12 years of age and older: 2 teaspoonfuls every 4 to 6 hours, not to exceed 12 teaspoonfuls. in 24 hours. Children 6 years to under 12 years of age: 1 teaspoonful every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours. Children 5 years to under 6 years of age (avg. 18kg (40 lbs)): 1⁄2 teaspoonful every 4 to 6 hours, not to exceed 2 teaspoonfuls in 24 hours. Children 3 years to under 5 years of age (avg. 14kg (30 lbs) to 16kg (35 lbs)): 1⁄4 teaspoonful every 4 to 6 hours, not to exceed 1 teaspoonful in 24 hours. Not recommended for children under the age of 3 unless as directed by a physician. Parents should be instructed to obtain and use a dispensing device (such as a dropper calibrated for age or weight) to administer the drug to a child, to use extreme care in measuring dosage, and not to exceed recommended daily dosage. CODEINE IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER 2 YEARS OF AGE. Children under 2 years of age may be more susceptible to the respiratory depressant effects of codeine, including respiratory arrest, coma, and death. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN AND TO SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE." ], "adverse_reactions": [ "ADVERSE REACTIONS Guaifenesin is well tolerated and has a wide margin of safety. Nausea and vomiting are the side effects that occur most commonly. Other reported adverse reactions have included dizziness, headache, and rash (including urticaria). Codeine: Nausea, vomiting, constipation, drowsiness, and miosis have been reported. Higher doses may induce euphoria, light headedness, dizziness, drowsiness, and depression of respiration. Pruritus and skin rashes have been rare." ], "how_supplied": [ "HOW SUPPLIED Guaifenesin 200 mg and codeine phosphate 10 mg per 5 ml of clear, colorless liquid in bottles of 16 oz (473 ml) (NDC 68047-222-16). Storage and Handling Storage - Store at controlled room temperature - 15°-30°C (59°-86°F). Protect from light. Keep bottle tightly closed. Distributed by: Larken Laboratories, Inc. Madison, MS 39110 Questions or Comments: 888-527-5522 Manufactured by: Deltex Pharmaceuticals, Inc. Rosenburg, TX 77471 Rev. 09/08" ], "information_for_patients": [ "Information for Patients Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby’s doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services)." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 1 : Container Label 5e470c5c-figure-03" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY ExeClear-C Syrup combines the expectorant, guaifenesin and the cough suppressant, codeine. Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. By increasing sputum volume and making sputum less viscous, guaifenesin facilitates expectoration of retained secretions. Codeine is a centrally acting antitussive agent." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies of ExeClear-C Syrup to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed." ], "nonteratogenic_effects": [ "Nonteratogenic Effects Nonteratogenic Effects: Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyper-reflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life." ], "overdosage": [ "OVERDOSAGE If overdosage occurs, treat symptomatically. Gastric emptying (emesis and/or gastric lavage) is recommended. Severe intoxication with codeine may result in dyspnea, vertigo, double vision, delusions, hallucinations, speech disturbances, excitement, restlessness, delirium, constricted pupils, respiratory depression (slow and shallow breathing), Cheyne-Stokes respiration, circulatory collapse, stupor, and coma. Treatment of overdosage consists primarily of support of vital functions, especially management of codeine-induced respiratory depression. The narcotic antagonist naloxone is a specific antidote for respiratory depression which may result from overdose or unusual sensitivity from narcotics." ] }, { "effective_time": "20151005", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, caramel, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, maltol, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "Warnings" ], "spl_product_data_elements": [ "tussin adult chest congestion Guaifenesin GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID CARAMEL FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP MALTOL MENTHOL PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE dark" ], "ask_doctor": [ "Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 – 20 mL every 4 hours children under 12 years do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition." ], "storage_and_handling": [ "Other information • store at 20-25°C (68-77°F). Do not refrigerate." ], "package_label_principal_display_panel": [ "Principal Display Panel ADULT TUSSIN CHEST CONGESTION EXPECTORANT (GUAIFENESIN) NON-DROWSY Relieves: MUCUS CHEST CONGESTION Alcohol Free For Ages 12 & Over Gluten Free COMPARE TO ROBITUSSIN® MUCUS + CHEST CONGESTION active ingredient 4 FL OZ (118 mL) Western Family Adult Tussin Image 1 Western Family Adult Tussin Image 2" ], "indications_and_usage": [ "Use helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive" ], "set_id": "3cfc8b00-adaf-4e41-9b2a-d13e6d1c9000", "id": "7a261ba0-9578-49c0-abda-4c8b483b93bf", "active_ingredient": [ "Active ingredient (in each 10 mL) Guaifenesin, USP 200 mg" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over 10 – 20 mL every 4 hours
children under 12 years do not use
" ] }, { "effective_time": "20150116", "inactive_ingredient": [ "Purified Water,Sorbitol, Polyethylene Glycol 1500, Carboxymethylcellulose Sodium, Sodium Lauryl Sulfate, Flavour, Carbomer Homopolymer Type C, Hydrated Silica, Saccharin Sodium,Methylparaben, Propylparaben" ], "purpose": [ "Purpose: Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under six years of age" ], "warnings": [ "For external use only. Keep out of reach of children" ], "spl_product_data_elements": [ "MegaFresh SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL POLYETHYLENE GLYCOL 1500 CARBOXYMETHYLCELLULOSE SODIUM SODIUM LAURYL SULFATE CARBOMER HOMOPOLYMER TYPE C HYDRATED SILICA SACCHARIN SODIUM METHYLPARABEN PROPYLPARABEN" ], "ask_doctor": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor." ], "package_label_principal_display_panel": [ "label" ], "indications_and_usage": [ "Uses: Aids in the prevention of dental cavities" ], "set_id": "3ef5fc36-d922-4574-a280-a8ad4a1c763a", "id": "1e9bad2c-9dd6-43ba-af20-9e7865d450ad", "active_ingredient": [ "Active Ingredient: Sodium Fluoride (0.22%)" ] }, { "effective_time": "20100617", "inactive_ingredient": [ "Inactive ingredients alcohol, carboxymethylcellulose sodium, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, polyethylene oxide, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate" ], "purpose": [ "Purpose Cough suppressant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-800-342-6844 www.vicks.com" ], "spl_product_data_elements": [ "Vicks 44 Cough Relief Dextromethorphan Hydrobromide Dextromethorphan Hydrobromide Dextromethorphan" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use dose cup, teaspoon (tsp), or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 years and over 1 TBSP (15 ml) every 6 – 8 hours children 6 to under 12 years 1½ tsp (7½ ml) every 6 – 8 hours children under 6 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each tablespoon contains sodium 28 mg store at room temperature" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label NON- DROWSY VICKS ® FORMULA 44 COUGH RELIEF Maximum Strength Cough Relief Dextromethorphan HBr...Cough Suppressant 6 FL OZ (177 ml) Alcohol 5% PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label" ], "indications_and_usage": [ "Use temporarily relieves cough due to minor throat and bronchial irritation associated with a cold" ], "set_id": "4127e5d9-a2bd-4a0c-9737-0174bad93c4f", "id": "e7e7b424-d9ba-4d6f-b5e6-8906ca4c4866", "active_ingredient": [ "Active ingredient (in each 15 ml tablespoon) Dextromethorphan HBr 30 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 TBSP (15 ml) every 6 – 8 hours
children 6 to under 12 years 1½ tsp (7½ ml) every 6 – 8 hours
children under 6 years ask a doctor
" ] }, { "effective_time": "20150731", "inactive_ingredient": [ "Inactive ingredients FD&C Red No. 3, FD&C Red No. 40, hypromelloses, L-menthol, magnesium aluminum silicate, mint essence, polysorbate 80, propylene glycol, propylparaben, purified water, salicylic acid, sodium saccharin, sodium salicylate, sorbic acid, sucrose, xanthan gum" ], "purpose": [ "Uses relieves diarrhea heartburn indigestion nausea gas belching fullness" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome: children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicytate products" ], "when_using": [ "When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur Stop use and ask a doctor if diarrhea lasts more than 2 days symptoms get worse ringing in the ears or loss of hearing occurs" ], "spl_product_data_elements": [ "Family Care Stomach Relief Bismuth subsalicylate BISMUTH SUBSALICYLATE SALICYLIC ACID FD&C RED NO. 3 FD&C RED NO. 40 HYPROMELLOSES MENTHOL MAGNESIUM ALUMINUM SILICATE POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER SALICYLIC ACID SODIUM SALICYLATE SORBIC ACID SUCROSE XANTHAN GUM" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool Ask a doctor before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Distributed by: United Exchange Corp. Cerritos, CA 90703 USA Made in Korea" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each 30 mL dose cup contains: sodium 10 mg salicylate 202 mg magnesium 25 mg protect from freezing avoid excessive heat (over 104° or 40°C) low sodium" ], "do_not_use": [ "Do not use if you have an ulcer a bleeding problem bloody or black stool" ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "Directions shake well before use for accurate dosing, use dose cup adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea" ], "set_id": "41361b56-1d2d-4368-9bef-42686e14e477", "id": "f4acd1f2-ba98-46c3-80e9-69eaffb79218", "active_ingredient": [ "Active ingredient (in each 30 mL dose cup) Purpose Bismuth subsalicylate 525 mg..........................Upset stomach reliever and antidiarrheal" ] }, { "effective_time": "20150504", "inactive_ingredient": [ "Inactive ingredients citric acid anhydrous, dextrose, FD&C blue #1, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-866-MUCINEX (1-866-682-4639) or www.mucinex.com" ], "spl_product_data_elements": [ "Mucinex for Kids Guaifenesin Guaifenesin Guaifenesin anhydrous citric acid dextrose FD&C blue no. 1 FD&C red no. 40 glycerin methylparaben potassium sorbate propylene glycol propylparaben water saccharin sodium sodium hydroxide sucralose xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than 6 doses in any 24-hour period Age Dose children 6 years to under 12 years 1- 2 teaspoonfuls every 4 hours children 4 years to under 6 years ½ -1 teaspoonful every 4 hours children under 4 years do not use" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Reckitt Benckiser Inc. Parsippany, NJ 07054-0224" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness." ], "storage_and_handling": [ "Other information each 5 mL teaspoonful contains: sodium 3 mg tamper evident: do not use if seal under bottle cap printed \"SEALED for YOUR PROTECTION\" is torn or missing. store between 20-25°C (68-77°F) do not refrigerate dosage cup provided" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton NDC 63824-273-64 Mucinex ® Guaifenesin Oral Solution EXPECTORANT For Kids! Grape Flavor Liquid Relieves Chest Congestion Thins And Loosens Mucus Alcohol-Free 4 FL OZ (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive" ], "set_id": "41acc6ab-8acb-4888-88a4-341b863d3943", "id": "7c91a1eb-cfc3-4133-84a0-04690f86186d", "active_ingredient": [ "Active ingredient (in each 5 mL tsp) Guaifenesin 100 mg" ], "dosage_and_administration_table": [ "
Age Dose
children 6 years to under 12 years 1- 2 teaspoonfuls every 4 hours
children 4 years to under 6 years ½ -1 teaspoonful every 4 hours
children under 4 years do not use
" ] }, { "effective_time": "20100611", "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive Ingredient: Purified water.", "Inactive ingredients flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose" ], "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Use: For preparation of skin before injection.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporary relief of minor aches, pains and headaches to reduce fever associated with colds, sore throats, teething", "Uses: For hand washing to decrease bacteria on the skin" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only.", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product.", "Warnings: For external use only Flammable, keep away from fire or flame" ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Wipe Injection site vigorously and discard." ], "spl_product_data_elements": [ "Good Neighbor Pharmacy Emergency Preparedness and First Aid Contains 167 Pieces BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ASPIRIN, ETHYL ALCOHOL Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Chewable Aspirin ASPIRIN ASPIRIN ASPIRIN FD&C YELLOW NO. 6 SACCHARIN SODIUM CATION SILICON DIOXIDE STARCH, CORN STEARIC ACID SUCROSE ORANGE ASPIRIN Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B Genuine Hand Sanitizer ALCOHOL ALCOHOL ALCOHOL" ], "description": [ "LOT/EXP: Made in CHINA 20130301", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "LOT/EXP: Made in CHINA 20140301", "Made in CHINA LOT/EXP:", "MADE IN USA Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "ask_doctor": [ "Ask a doctor before use if you have; asthma stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems a child experiencing arthritis pain if you are; allergic to aspirin taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions Do not use more than directed Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours, Do not exceed 48 tablets in 24 hours unless directed by a doctor. Children Under 12 years: Consult a doctor.", "Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and ask a doctor if; an allergic reaction occurs, Seek medical help right away pain or fever persists new or unexpected symptoms occur redness or swelling is present ringing in ears or loss of hearing occurs", "Stop use and consult a doctor if irritation and redness develop and persist for more than 72 hours." ], "storage_and_handling": [ "Other Information: Store at room temperature", "Other information: Store at room temperature.", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Flammable - keep away from fire or flame.", "Store at room temperature tamper evident sealed packets do not use any opened or torn packets", "Other Information: Store at 15 to 25 degree Celsius (59 to 77 degree Fahrenheit)" ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: with electrocautery, in the eyes.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you are allergic to aspirin or any other pain relievers/fever reducers for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor for at least 7 days after a tonsillectomy or oral surgery", "Do not use in the eyes. In case of contact, rinse eyes thoroughly with water." ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Antiseptic Towelette", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "GenuineTripleAntibiotic", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "GenuineEyeWash", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AlcoholCleansingPad", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "2 Tablets GENUINE FIRST AID. Chewable Aspirin 81mg", "Chewable Aspirin 81mg", "Genuine Hand Sanitizer Instant Gel Antiseptic Handwash with Vitamin E and Aloe Kills 99.9 percent of germs Without Water Active Ingredient: Ethyl Alcohol 62 percent Net Wt 0.9g (1/32 oz) Manufactured in China For Genuine First Aid.", "Genuine Hand Sanitizer", "GENUINE FIRST AID. CONTAINS 167 PIECES Genuine Emergency Preparedness and First Aid Kit HOME WORK OUTDOORS OFFICE AUTO New ! 1 Emergency Preparedness 1 2 Emergency Preparedness 2 3 Small Cuts and Burns 4 Medium Cuts/Burns and Severe Bleeding 5 Protection and CPR 6 Instruments REFILL PACKS AVAILABLE FOR EACH POCKET Carrying Case 1 Soft-side Bag 1 Easy Access Pocket System Emergency Preparedness (1) 1 Emergency Poncho 50\"X80\" 1 Emergency Blanket 38\"X60\" Emergency Preparedness (2) 1 Procedural Mask, 3 Ply 1 Whistle 1 Light Stick 1 Radio w/ Headphones and Flashlight 2 Batteries Medium Cuts, Burns and Severe Bleeding 1 First Aid Tape Roll 1/2\"x 2.5yds 1 Combine Pad 5\"X9\" 1 Roller Gauze Bandage 3\"X4.1yds 1 Antiseptic Towelette 1 Triple Antibiotic Ointment 0.9gr 1Sterile Gauze Pad 2\"X2\" 1 Sterile Eye Pad 1 Sterile Eye Wash 10ml 1 Burn Cream Protection and CPR 2 Medical Grade Vinyl Gloves 1 Instant Cold Compress 2 Alcohol Cleansing Pads 1 Insect Sting Relief Pad 2 Chewable Aspirin Tablets 1 Triangular Bandage 42\"x42\"x59\" 1 CRP Breathing Barrier 1 Hand Sanitizer Instruments 1 Emergency First Aid Guide 1 Emergency Preparedness Refill Guide 1 Plastic Tweezers 1 Thermometer Strip 1 Scissors 6 Assorted Safety Pins 2 Wooden Finger Splints Copyright c 2009 Genuine First Aid LLC. All rights reserved. Manufactured in China for: Genuine First Aid LLC. 600 Cleveland Street Suite 400 Clearwater, FL 33755 www.GenuineFirstAid.com GENUINE FIRST AID", "Amerisource Emergency Preparedness Kit 167" ], "set_id": "42593c25-244f-44bb-a783-65608f9ab891", "id": "31fe4b5d-bdbe-4366-b4b6-85fb0b4dba30", "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID*). . . . . . . . . . . . . Analgesic/Antipyretic *nonsteroidal anti-inflammatory drug", "Active Ingredient: Ethyl Alcohol 62 percent" ] }, { "effective_time": "20120829", "drug_interactions": [ "Drug Interactions Patients receiving other narcotic analgesics, anti-psychotics, anti-anxiety agents, or other CNS depressants (including alcohol) concomitantly with this drug may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. The concurrent use of anticholinergics with codeine may produce paralytic ileums. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, anti-anxiety agents." ], "geriatric_use": [ "Geriatric Use The elderly (60 years of age or older) are more likely to exhibit adverse reactions. Caution should be taken when prescribing this drug to the elderly." ], "precautions": [ "PRECAUTIONS General Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided. Because of its sympathomimetic component EndaCof-C Liquid should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease. Information for Patients Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Patients should be cautioned to get up slowly from a lying or sitting position and to lie down if nausea occurs. Drug Interactions Patients receiving other narcotic analgesics, anti-psychotics, anti-anxiety agents, or other CNS depressants (including alcohol) concomitantly with this drug may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. The concurrent use of anticholinergics with codeine may produce paralytic ileums. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, anti-anxiety agents. Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies of EndaCof-C Liquid to assess the carcinogenic and mutagenic potential to the effect on fertility have not been performed. Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with EndaCof-C Liquid. It is also not known whether EndaCof-C Liquid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. EndaCof-C Liquid should be given to a pregnant woman only if clearly needed. Nursing Mothers EndaCof-C Liquid is contraindicated in nursing mothers. Pediatric Use Not recommended for use in patients under 6 years of age. Geriatric Use The elderly (60 years of age or older) are more likely to exhibit adverse reactions. Caution should be taken when prescribing this drug to the elderly." ], "description": [ "DESCRIPTION EndaCof-C Liquid is a sugar free, alcohol free, dye free, gluten free, cotton candy flavored antitussive/antihistamine available for oral administration. Each teaspoonful (5 mL) contains: Codeine Phosphate ………..……. 10 mg (WARNING: May be habit forming) Chlorpheniramine Maleate ….... 2 mg Codeine Phosphate is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is affected by light. Its chemical name is: 7,8-Didehydro-4,5-(-epoxy-3-methoxy-17-methylmorphinan<-6-(-ol phosphate (1:1) (salt) hemihydrate. Its structure is as follows: Figure 1 C 18 H 21 NO 3 • H 3 PO 4 • ½ H 2 O M.W. 406.37 Chlorpheniramine Maleate is an antihistamine having the chemical name: 2-Pyridinepropanamine, γ-(4-chlorphenyl) -N,N-dimethyl-, (Z)-2-butenedioate (1:1). , and has the following chemical formula: Figure 2 C 16 H 19 ClN 2 • C 4 H 4 O 4 M.W. 390.86" ], "general_precautions": [ "General Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided. Because of its sympathomimetic component EndaCof-C Liquid should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease." ], "storage_and_handling": [ "Storage and Handling Store at 15°-30°C (59°-86°F) [see USP Controlled Room Temperature.] Distributed by: Larken Laboratories, Inc. Canton, MS 39046 Manufactured by: Deltex Pharmaceutical, Inc. Rosenberg, TX 77471 Rev. 03/09" ], "indications_and_usage": [ "INDICATIONS AND USAGE Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Temporarily reduces the intensity of coughing. Suppresses the impulse to cough to help you rest. Temporarily relieves runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies (allergic rhinitis)." ], "set_id": "4374b297-1784-439e-9060-270de4561e3d", "id": "5514569a-e047-454d-96d4-bf46b0454323", "pediatric_use": [ "Pediatric Use Not recommended for use in patients under 6 years of age." ], "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredients: Propylene glycol, Sorbitol, Citric acid, Sodium benzoate, Saccharin sodium, Cotton candy flavor, Purified Water." ], "contraindications": [ "CONTRAINDICATIONS Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Do not use in newborn infants, premature infants, in nursing mothers, in patients with severe hypertension, severe coronary artery disease, ischemic heart disease, or in those receiving monoamine oxidase (MAO) inhibitors. EndaCof-C Liquid should not be used during pregnancy or in nursing mothers. Antihistamines are contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer, and during an asthma attack. Antihistamines should not be used to treat lower respiratory tract conditions including asthma." ], "warnings": [ "WARNINGS May cause excitability especially in children. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor. May cause or aggravate constipation. Use caution when giving to children or patients with chronic pulmonary disease, shortness of breath, difficulty in breathing, asthma, emphysema, high blood pressure, heart disease, diabetes, thyroid disease, or difficulty in urination due to enlargement of the prostate gland unless directed by a physician. Antihistamines may cause hyper excitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling." ], "pregnancy": [ "Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with EndaCof-C Liquid. It is also not known whether EndaCof-C Liquid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. EndaCof-C Liquid should be given to a pregnant woman only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers EndaCof-C Liquid is contraindicated in nursing mothers." ], "spl_product_data_elements": [ "EndaCof-C Codeine Phosphate and Chlorpheniramine Maleate CODEINE PHOSPHATE CODEINE ANHYDROUS CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PROPYLENE GLYCOL SORBITOL CITRIC ACID MONOHYDRATE SODIUM BENZOATE SACCHARIN SODIUM DIHYDRATE WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION* Adults and children 12 years of age and over: 1 to 2 teaspoonfuls (5-10 mL) every 4 to 6 hours. Not to exceed 8 teaspoonfuls in a 24 hour period. Children 6 to under 12 years of age: 1/2 to 1 teaspoonful (2.5 - 5 mL) every 4 to 6hours. Not to exceed 4 teaspoonfuls in a 24 hour period. *In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate." ], "adverse_reactions": [ "ADVERSE REACTIONS The most frequent adverse reactions to EndaCof-C Liquid include sedation; dryness of mouth, nose, and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extra systoles. Dermatologic: Urticaria, drug rash, photosensitivity, and pruritus. Central Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. Gastrointestinal: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. Genitourinary: Urinary frequency, difficult urination, urinary retention, early menses. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis." ], "how_supplied": [ "HOW SUPPLIED EndaCof-C Liquid is a sugar free, alcohol free, dye free, clear, cotton candy flavored, liquid in 16 fl oz. (473mL) bottles, NDC 68047-145-16. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Storage and Handling Store at 15°-30°C (59°-86°F) [see USP Controlled Room Temperature.] Distributed by: Larken Laboratories, Inc. Canton, MS 39046 Manufactured by: Deltex Pharmaceutical, Inc. Rosenberg, TX 77471 Rev. 03/09" ], "information_for_patients": [ "Information for Patients Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Patients should be cautioned to get up slowly from a lying or sitting position and to lie down if nausea occurs." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Figure 3: Container label 5514569a-figure-01 5514569a-figure-02 5514569a-figure-03" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Codeine Phosphate Codeine is a centrally acting analgesic and antitussive which is w ell absorbed orally. Following absorption, codeine is metabolized by the liver and metabolic products are excreted in the urine. Chlorpheniramine Maleate Chlorpheniramine is an alkylamine type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses. The drugs are not so prone to produce drowsiness and are therefore among the most suitable agents for daytime use, but a significant proportion of patients do experience this effect." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies of EndaCof-C Liquid to assess the carcinogenic and mutagenic potential to the effect on fertility have not been performed." ], "overdosage": [ "OVERDOSAGE Codeine Signs and Symptoms: Overdosage with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), pinpoint pupils, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest and death may occur. Treatment: Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheotomy may be necessary prior to lavage. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated. Chlorpheniramine Maleate Signs and Symptoms: Antihistamine overdosage may vary from central nervous system depression (sedation, apnea, and cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors or convulsions). Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision, and hypotension. Stimulation and atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; hyperthermia, and gastrointestinal symptoms) are particularly likely in children. Treatment: Emergency treatment should be started immediately. Vomiting should be induced, even if it has occurred spontaneously. Vomiting by the administration of ipecac syrup is preferred. Vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of eight to twelve fluid ounces of water. If emesis does not occur within fifteen minutes, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Isotonic and one-half isotonic saline are the lavage solutions of choice. Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and, therefore, may be valuable for their action in rapid dilution of bowel content. After emergency treatment the patient should continue to be medically monitored. Treatment of the signs and symptoms of overdosage is symptomatic and supportive. Stimulants (analeptic agents) should not be used. Vasopressors may be used to treat hypotension. Short-acting barbiturates, diazepam, or paraldehyde may be administered to control seizures. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or a hypothermic blanket. Apnea is treated with ventilatory support." ] }, { "effective_time": "20111202", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate" ], "purpose": [ "Purpose Cough suppressant Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Wal Tussin Dextromethorphan Hydrobromide, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE Orange-Red" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than 6 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 tsp every 4 hours children under 12 years do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition." ], "storage_and_handling": [ "Other information store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to Robitussin® DM active ingredients SEE NEW DOSING DIRECTIONS Adult WAL-TUSSIN® COUGH AND CHEST CONGESTION DM Cough Suppressant (Dextromethorphan HBr) Expectorant (Guaifenesin) Relieves: Coughs Chest Congestion Non-Drowsy For Ages 12 & Over Alcohol-Free CHERRY FLAVOR Wal-Tussin® Carton Image 1 Wal-Tussin® Carton Image 2 Wal-Tussin (R) Carton Image 1 Wal-Tussin (R) Carton Image 2" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes" ], "set_id": "4412b49d-440f-46c6-8791-cc8f0819753c", "id": "3fafeaf8-e818-46b8-85b9-bff6d1b88b38", "active_ingredient": [ "Active ingredient (in each 5 mL tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg" ], "dosage_and_administration_table": [ "
age dose
adults and children12 years and over 2 tsp every 4 hours
children under 12 years do not use
" ] }, { "effective_time": "20151209", "purpose": [ "Active ingredients (in each teaspoonful) Purpose Brompheniramine Maleate 4 mg Antihistamine Dextromethorphan Hydrobromide 20 mg Antitussive (cough suppressant) Phenylephrine Hydrochloride 10 mg Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions? Comments? To report a serious adverse event or obtain product information, Call 1-630-530-7000." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information Store at 59°-86°F (15°-30°C) [see USP for Controlled Room Temperature]" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion temporarily restores freer breathing through the nose congestion reduces swelling of nasal passages" ], "set_id": "441bf71a-042b-48a9-952e-d4dc754d0ae6", "id": "a072f9ee-7b72-4c8f-81db-9f0b2e022a67", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other nasal decongestant or stimulant taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each teaspoonful) Purpose Brompheniramine Maleate 4 mg Antihistamine Dextromethorphan Hydrobromide 20 mg Antitussive (cough suppressant) Phenylephrine Hydrochloride 10 mg Nasal Decongestant" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and over: 1 teaspoonful every 4 hours
Children under 12 years of age: Consult a physician
" ], "inactive_ingredient": [ "Inactive ingredients Fruit gum flavor, citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol." ], "warnings": [ "Warnings Do not exceed recommended dosage. Do not use this product to sedate a child or make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occur with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking any other nasal decongestant or stimulant taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Glenmax PEB DM FORTE DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BROMPHENIRAMINE MALEATE BROMPHENIRAMINE CITRIC ACID MONOHYDRATE PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL GLYCERIN" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occur with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Do not exceed 4 dosage in a 24-hour period. Adults and children 12 years of age and over: 1 teaspoonful every 4 hours Children under 12 years of age: Consult a physician" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Glendale Inc Villa Park, IL 60181" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use this product to sedate a child or make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each teaspoonful) Purpose
Brompheniramine Maleate 4 mg Antihistamine
Dextromethorphan Hydrobromide 20 mg Antitussive (cough suppressant)
Phenylephrine Hydrochloride 10 mg Nasal Decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 70147-0223-16 Glenmax PEB DM FORTE Antihistamine/Antitussive Nasal Decongestant Each teaspoonful for oral administration contains: Brompheniramine Maleate 4 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg SUGAR FREE / DYE FREE ALCOHOL FREE Fruit Gum Flavored Liquid Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Distributed by: Glendale Inc Villa Park, IL 60181 16 fl oz. (473 mL) Principal Display Panel - 473 mL Bottle Label" ], "purpose_table": [ "
Active ingredients (in each teaspoonful) Purpose
Brompheniramine Maleate 4 mg Antihistamine
Dextromethorphan Hydrobromide 20 mg Antitussive (cough suppressant)
Phenylephrine Hydrochloride 10 mg Nasal Decongestant
" ] }, { "effective_time": "20100604", "purpose": [ "Active ingredients (in each 15 ml tablespoon) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "questions": [ "Questions? 1-800-362-1683" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains sodium 19 mg store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing" ], "set_id": "446417bd-4a52-440a-923a-52ce09b9f2d2", "id": "fe195559-1472-458f-8d0a-ee085b4b64ef", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine" ], "dosage_and_administration_table": [ "
adults & children 12 yrs and over 30 ml (2 TBSP) every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD&C Blue 1, FD&C Red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate" ], "warnings": [ "Warnings Liver warning Product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hrs with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than directed dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Doxylamine succinate Doxylamine" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hrs adults & children 12 yrs and over 30 ml (2 TBSP) every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other DayQuil® or NyQuil products, carefully read each label to insure correct dosing" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202. www.vicks.com" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "active_ingredient_table": [ "
Active ingredients (in each 15 ml tablespoon) Purpose
Acetaminophen 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 295 ml Bottle Label VICKS ® NyQuil ® Cherry Flavor COLD & FLU Multi-Symptom Relief Acetaminophen…Aches, Fever Dextromethorphan…Cough Doxylamine…Sneezing, Runny Nose 10 FL OZ (295 ml) Alcohol 10% See Drug Facts Principal Display Panel - 295 ml Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 15 ml tablespoon) Purpose
Acetaminophen 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
" ], "overdosage": [ "Overdose warning Taking more than directed dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20110829", "inactive_ingredient": [ "Inactive ingredients cherry flavor, citric acid, FD and C red no. 40, glycerin, high fructose corn syrup, sucrose, sucralose, menthol, propylene glycol, purified water, xanthan gum, polysorbate, saccharin sodium, sodium benzoate" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if, cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Tussin Chest Guaifenesin GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP SUCROSE SUCRALOSE MENTHOL PROPYLENE GLYCOL WATER XANTHAN GUM POLYSORBATE 80 SACCHARIN SODIUM SODIUM BENZOATE" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "other_safety_information": [ "Other information each teaspoon contains :sodium 1mg store at 20-25°C (68-77°F) alcohol-free dosage cup provided" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than 6 doses in any 24-hour period Age Dose adults and children 12 years and over 2-4 tsp every 4 hours children 6 years to under 12 years 1-2 tsp every 4 hours children 2 years to under 6 years 1/2-1 tsp every 4 hours under 2 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if, cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "package_label_principal_display_panel": [ "Package label Tussin Chest image of carton label" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive." ], "set_id": "44deb716-d5ee-473f-bac3-9510d326224a", "id": "0d5c9dfc-7adc-499d-8da9-0ccd034826bb", "active_ingredient": [ "Active ingredients (in each 5mL tsp) Guaifenesin, USP 100mg" ], "dosage_and_administration_table": [ "
Age Dose
adults and children 12 years and over 2-4 tsp every 4 hours
children 6 years to under 12 years 1-2 tsp every 4 hours
children 2 years to under 6 years 1/2-1 tsp every 4 hours
under 2 years ask a doctor
" ] }, { "effective_time": "20130730", "inactive_ingredient": [ "INACTIVE INGREDIENTS: WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 5, BLUE 1" ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "warnings": [ "WARNINGS DO NOT USE IF YOU HAVE PAINFUL OR SWOLLEN GUM LINE, LOOSE TEETH OR INCREASED SPACING BETWEEN THE TEETH. SEE YOUR DENTIST IMMEDIATELY. THESE MAY BE SIGNS OF PERIODONTITIS, A SERIOUS FORM OF GUM DISEASE. DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE. STOP USE AND ASK A DENTIST IF GINGIVITIS, BLEEDING OR REDNESS PERSISTS FOR MORE THAN 72 HOURS. KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "spl_product_data_elements": [ "Amber Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE FD&C YELLOW NO. 5 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER. VIGOROUSLY SWISH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) BETWEEN TEETH FOR 30 SECONDS THEN SPI9T OUT;DO NOT SWALLOW. CHILDREN UNDER 12 YEARS OF AGE, CONSULT A DENTIST OR DOCTOR. THIS RINSE IS NOT INTENDED TO REPLACE BRUSHING OR FLOSSING." ], "storage_and_handling": [ "OTHER INFORMATION COLD WATER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED. STORE AT ROOM TEMPERATURE (59°-77°F)." ], "package_label_principal_display_panel": [ "image of label" ], "indications_and_usage": [ "USES TO HELP CONTROL PLAQUE THAT LEADS TO GINGIVITIS." ], "set_id": "45cd7964-2520-48f2-8155-35467b8f49f0", "id": "3e53869c-ea36-4599-849f-ff629a1be9b7", "active_ingredient": [ "ACTIVE INGREDIENT EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20141027", "inactive_ingredient": [ "Inactive ingredients carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask adoctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur especially in children be careful when driving a motor vehicle or operating machinery If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "pregnancy": [ "If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "when_using": [ "When using this product avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur especially in children be careful when driving a motor vehicle or operating machinery If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "spl_product_data_elements": [ "Childrens allergy relief antihistamine DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARBOXYMETHYLCELLULOSE SODIUM ANHYDROUS CITRIC ACID GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL clear" ], "ask_doctor": [ "Ask adoctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur especially in children be careful when driving a motor vehicle or operating machinery If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take every 4 to 6 hours do not take more than 6 doses in 24 hours Age (yr) Dose (mL or tsp) children under 2 years do not use children under 6 years ask a doctor children 6 to under 12 years 1 to 2 tsp (5 mL to 10 mL) adults and children 12 years and above 2 to 4 tsp (10 mL to 20 mL)" ], "storage_and_handling": [ "Other information each tsp contains: sodium 5 mg dosing cup provided store at 68 o - 77 o F" ], "do_not_use": [ "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask adoctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur especially in children be careful when driving a motor vehicle or operating machinery If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "package_label_principal_display_panel": [ "PDP Sunmark Compare to childrens benadyl active ingredient Children's allergy relief dye-free antihistamine Relieves sneezing, runny nose, itchy, watery eyes, itchy throat Diphenhydramine HCl antihistamine Bubblegum Flavor 4 fl oz (118mL) SN" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "4609efc1-71d3-401e-b5f6-0caf48e8670f", "id": "ea16aeba-89fc-4246-b244-4c3f1b267791", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur especially in children be careful when driving a motor vehicle or operating machinery If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "active_ingredient": [ "Active ingredient (in each 5 mL tsp) Diphenhydramine HCl 12.5 mg" ], "dosage_and_administration_table": [ "
Age (yr) Dose (mL or tsp)
children under 2 years do not use
children under 6 years ask a doctor
children 6 to under 12 years 1 to 2 tsp (5 mL to 10 mL)
adults and children 12 years and above 2 to 4 tsp (10 mL to 20 mL)
" ] }, { "effective_time": "20131213", "inactive_ingredient": [ "Inactive ingredients calcium carbonate, D and C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium." ], "purpose": [ "Purpose Upset stomach reliever and anti-diarrheal" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product , if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have bloody or black stools an ulcer a bleeding problem Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis When using this product a temporary, but harmless darkening of the stool and/or tongue may occur. Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately." ], "when_using": [ "When using this product a temporary, but harmless darkening of the stool and/or tongue may occur." ], "spl_product_data_elements": [ "Bismatrol Bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION CALCIUM CARBONATE D&C RED NO. 27 MAGNESIUM STEARATE MANNITOL STARCH, CORN SACCHARIN SODIUM GDC122" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions chew or dissolve in mouth adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed do not take more than 8 doses (16 tablets) in 24 hours children under 12 years: ask a doctor drink plenty of fluids to help prevent dehydration which may accompany diarrhea. Other information: each tablet contains: sodium less than 1 mg salicylate 102 mg calcium 140 mg very low sodium avoid excessive heat (over 104˚F or 40˚C) TAMPER EVIDENT: Do not use if individual compartments are torn or missing." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately." ], "stop_use": [ "Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days" ], "do_not_use": [ "Do not use if you have bloody or black stools an ulcer a bleeding problem" ], "package_label_principal_display_panel": [ "Principal Display Panel Bismatrol Chewable Tablets soothing, coating action provides fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea compare to the active ingredient in Pepto-Bismol ® 30 chewable tablets Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 IMAGE LABEL" ], "indications_and_usage": [ "Uses relieves: diarrhea heartburn indigestion nausea upset stomach associated with these symptoms" ], "set_id": "4706704a-d970-48b8-89d4-c73a8fb761ca", "id": "c5eb25f0-c650-4cc7-8f2c-60574e93c8fc", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)" ] }, { "effective_time": "20150113", "purpose": [ "Active ingredients (in each 5 mL) Purpose Pyrilamine Maleate 16 mg Antihistamine Phenylephrine HCl 5 mg Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 800-222-1222" ], "when_using": [ "May cause excitability, especially in children", "When using this product Do not exceed recommended dosage. drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? Call 1-877-622-6836" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use" ], "storage_and_handling": [ "Other Information store at controlled room temperature 20°-25°C (68°-77°F) Tamper Evident: Do not use if seal is broken or missing." ], "indications_and_usage": [ "Uses temporarily relieves runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever or other upper respiratory allergies nasal congestion due to the common cold" ], "set_id": "47becf2e-30a8-45e9-a599-d5d2edc32df8", "id": "51536874-f752-434a-9746-cf0d840ea106", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use If you or your child are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each 5 mL) Purpose Pyrilamine Maleate 16 mg Antihistamine Phenylephrine HCl 5 mg Nasal Decongestant" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and older 1 to 2 teaspoonsful
Children 6 to under 12 years of age 1 teaspoonful
Children under 6 years of age Ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients Citric acid, FD&C Blue No. 1, FD&C Red No. 40, glycerin, grape flavor, magnesium aluminum silicate, methylparaben, purified water, sodium saccharin, sodium benzoate, sodium citrate dihydrate, sucrose, xanthan gum and galloquinate." ], "warnings": [ "Warnings May cause excitability, especially in children Do Not Use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, chronic bronchitis, or asthma Ask a doctor or pharmacist before use If you or your child are taking sedatives or tranquilizers When using this product Do not exceed recommended dosage. drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs if symptoms do not improve within 7 days or are accompanied by a fever, rash, or headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 800-222-1222" ], "spl_product_data_elements": [ "Pyril D PHENYLEPHRINE HYDROCHLORIDE and PYRILAMINE MALEATE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PYRILAMINE MALEATE PYRILAMINE CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN GRAPE MAGNESIUM ALUMINUM SILICATE METHYLPARABEN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE XANTHAN GUM TANNIC ACID" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, chronic bronchitis, or asthma" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions take every 6 hours do not take more than 4 doses in 24 hours or as directed by a doctor Adults and children 12 years of age and older 1 to 2 teaspoonsful Children 6 to under 12 years of age 1 teaspoonful Children under 6 years of age Ask a doctor" ], "package_label_principal_display_panel_table": [ "
Each 5 mL (one teaspoonful) for oral administration contains:
Pyrilamine Maleate 16 mg
Phenylephrine HCl 5 mg
" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs if symptoms do not improve within 7 days or are accompanied by a fever, rash, or headache. These could be signs of a serious condition." ], "do_not_use": [ "Do Not Use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL) Purpose
Pyrilamine Maleate 16 mg Antihistamine
Phenylephrine HCl 5 mg Nasal Decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label MACOVEN PHARMACEUTICALS, LLC NDC 44183-208-16 PYRIL D SUSPENSION Shake Well Each 5 mL (one teaspoonful) for oral administration contains: Pyrilamine Maleate 16 mg Phenylephrine HCl 5 mg GRAPE FLAVOR 16 fl. oz. (473 mL) Principal Display Panel - 473 mL Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 5 mL) Purpose
Pyrilamine Maleate 16 mg Antihistamine
Phenylephrine HCl 5 mg Nasal Decongestant
" ] }, { "effective_time": "20120731", "drug_interactions": [ "Drug Interactions: Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen oral solution may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone." ], "geriatric_use": [ "Geriatric Use: Clinical Studies of hydrocodone bitartrate and acetaminophen oral solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen oral solution and observed closely." ], "abuse": [ "Misuse, Abuse, and Diversion of Opioids: Hydrocodone bitartrate and acetaminophen oral solution contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion. Hydrocodone bitartrate and acetaminophen oral solution can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and acetaminophen oral solution in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE )." ], "precautions": [ "PRECAUTIONS General: Special Risk Patients: As with any narcotic analgesic agent, hydrocodone bitartrate and acetaminophen oral solution should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Cough Reflex: Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when hydrocodone bitartrate and acetaminophen oral solution is used postoperatively and in patients with pulmonary disease. Information for Patients/Caregivers: Do not take Hydrocodone Bitartrate and Acetaminophen Oral Solution if you are allergic to any of its ingredients. If you develop signs of allergy such as a rash or difficulty breathing stop taking Hydrocodone Bitartrate and Acetaminophen Oral Solution and contact your healthcare provider immediately. Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose. Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product, and should be avoided. Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Physicians should instruct patients and caregivers to read the patient information leaflet, which appears as the last section of the labeling. Laboratory Tests: In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. Drug Interactions: Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen oral solution may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. Drug/Laboratory Test Interactions: Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. Carcinogenesis, Mutagenesis, Impairment of Fertility: No adequate studies have been conducted in animals to determine whether hydrocodone has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Hydrocodone has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Acetaminophen has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow. Pregnancy: Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Hydrocodone bitartrate and acetaminophen oral solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. These signs usually appear during the first few days of life. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Labor and Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (See ). The effect of hydrocodone, if any, on the later growth, development, and functional maturation of the child is unknown. OVERDOSAGE Nursing Mothers: Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness in the pediatric population below the age of two years have not been established. Use of hydrocodone bitartrate and acetaminophen oral solution in the pediatric population is supported by the evidence from adequate and well-controlled studies of hydrocodone and acetaminophen combination products in adults, with additional data which support the development of metabolic pathways in children two years of age and over (See for pediatric dosage information). DOSAGE AND ADMINISTRATION Geriatric Use: Clinical Studies of hydrocodone bitartrate and acetaminophen oral solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen oral solution and observed closely." ], "spl_patient_package_insert": [ "HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 mg/500 mg per 15 mL CIII Rx only PATIENT INFORMATION Summary Hydrocodone bitartrate and acetaminophen oral solution is used to relieve moderate to moderately severe pain. You should not take hydrocodone bitartrate and acetaminophen oral solution if you are allergic to hydrocodone or acetaminophen. The most common side effects of hydrocodone bitartrate and acetaminophen oral solution are abdominal pain, dizziness, drowsiness, light-headedness, nausea, shortness of breath, unusual tiredness, and vomiting. Take this medicine as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Hydrocodone bitartrate and acetaminophen oral solution is an analgesic used to relieve moderate to moderately severe pain. Hydrocodone bitartrate and acetaminophen oral solution is a combination product containing hydrocodone (hye-droe-KO-done) bitartrate and acetaminophen (a-seat-a-MIN-oh-fen). Hydrocodone is a narcotic pain reliever and a cough suppressant. Acetaminophen is a non-narcotic pain reliever and fever reducer. A narcotic analgesic and acetaminophen used together may provide better pain relief than either product used alone. If you have any questions, please call your doctor or pharmacist. Uses General Cautions Do not take this drug if you have allergies or unusual reactions to narcotic pain relievers or acetaminophen, because it is likely that you may also be allergic to hydrocodone bitartrate and acetaminophen oral solution. This product may inhibit your mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while you are taking this product. This medicine may not be right for you. Check with your doctor or pharmacist, if you: are pregnant are nursing are taking other medications: narcotic pain relievers; allergy medicines; antidepressant medicines; acetaminophen-containing medicines or other medicines that cause central nervous system depression, including alcohol. have other medical problems: a history of drug or alcohol abuse; recent head injury; emphysema, asthma, or other chronic lung disease; liver disease, kidney disease; underactive thyroid, Addison's disease, enlarged prostate or difficulty urinating. Take this medicine as directed by your doctor. Do not share it with anyone else. This medicine can cause drug dependence and has the potential for abuse. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you think that this medicine is not working properly after taking it for some time, do not increase the dose. Check with your doctor or pharmacist. Proper Use The dose of this medication will be different for different patients. Follow the directions provided by your doctor. The following information includes only the average doses of this medication. Dosing If your dose is different, do not change doses unless your doctor tells you to do so. BODY WEIGHT APPROXIMATE AGE DOSE Every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE (6 doses per day) 12 to 15 kg (27 to 34 lbs.) 2 to 3 years ¾ teaspoonful = 3.75 mL 4½ teaspoonfuls = 22.5 mL 16 to 22 kg (35 to 50 lbs.) 4 to 6 years 1 teaspoonful = 5 mL 6 teaspoonfuls = 30 mL 23 to 31 kg (51 to 69 lbs.) 7 to 9 years 1½ teaspoonfuls = 7.5 mL 9 teaspoonfuls = 45 mL 32 to 45 kg (70 to 100 lbs.) 10 to 13 years 2 teaspoonfuls = 10 mL 12 teaspoonfuls = 60 mL 46 kg and up (101 lbs. and up) 14 years to adult 1 Tablespoonful = 15 mL 6 Tablespoonfuls = 90 mL It is very important that hydrocodone bitartrate and acetaminophen oral solution be dosed accurately. A household teaspoon or tablespoon is not an accurate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Since a household teaspoon is not accurate and can be mixed up with a tablespoon (which can cause overdosage), it is strongly recommended that you obtain and use a proper measuring device. Ask your doctor or pharmacist for help to find a dropper that can measure the needed dose properly and ask for help if you do not understand how to use the dropper. Missed Dose To avoid a possible overdose, it is important that you do not take more than a single dosage at one time, or that you don't take doses at intervals less than 4 hours apart. If you miss taking a dose of hydrocodone bitartrate and acetaminophen oral solution, take it as soon as you remember. However, make sure to wait at least 4 hours before taking your next dose. If you missed taking a dose, and it is almost time for your next dose, skip the missed dose and take your medicine as scheduled. Do not double the prescribed dose. Possible Side Effects Side effects you may experience include abdominal pain, constipation, difficulty urinating, dizziness, drowsiness, fear, fuzzy thinking, general feeling of discomfort or illness, light-headedness, mood changes, nausea, nervousness, rash, shortness of breath, slower reactions, unusual tiredness, and vomiting. Call your doctor if these effects continue or are bothersome. Side effects not listed above may sometimes occur. If you notice any other effects, check with your doctor. Storage Keep out of reach of children. Store at room temperature (protect from heat, do not refrigerate). Keep in original labeled bottle. Discard medicines that are old or no longer needed. Even a single overdose of this medicine may be a life-threatening situation. If you suspect that you or someone else may have taken more than the prescribed dose of this medicine, contact your local Poison Control Center or emergency room immediately. This medicine was prescribed for your particular condition. Do not use it for another condition or give the drug to others. This leaflet provides a summary of information about hydrocodone bitartrate and acetaminophen oral solution. If you have any questions or concerns, or want more information about hydrocodone bitartrate and acetaminophen oral solution, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about hydrocodone bitartrate and acetaminophen oral solution that is written for health professionals that you can ask to read. Manufactured for: Huntsville, AL 35811 QUALITEST PHARMACEUTICALS 8082888 R5/11-R4" ], "description": [ "DESCRIPTION Hydrocodone bitartrate and acetaminophen is supplied in liquid form for oral administration. (See , and ). WARNING: May be habit-forming PRECAUTIONS, Information for Patients DRUG ABUSE AND DEPENDENCE Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Hydrocodone Bitartrate and Acetaminophen Oral Solution contains: Per 5 mL Per 15 mL Hydrocodone Bitartrate ................................. 2.5 mg 7.5 mg Acetaminophen ............................................. 167 mg 500 mg Alcohol ........................................................... 7% 7% This is an image of the structural formula for hydrocodone bitartrate. This is an image of the structural formula for acetaminophen. In addition, the liquid contains the following inactive ingredients: D&C Yellow #10, ethyl maltol, FD&C Yellow #6, flavors, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution 70%, and sucrose. May also contain citric acid and sodium hydroxide." ], "labor_and_delivery": [ "Labor and Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (See ). The effect of hydrocodone, if any, on the later growth, development, and functional maturation of the child is unknown. OVERDOSAGE" ], "general_precautions": [ "General: Special Risk Patients: As with any narcotic analgesic agent, hydrocodone bitartrate and acetaminophen oral solution should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Cough Reflex: Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when hydrocodone bitartrate and acetaminophen oral solution is used postoperatively and in patients with pulmonary disease.", "Special Risk Patients: As with any narcotic analgesic agent, hydrocodone bitartrate and acetaminophen oral solution should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.", "Cough Reflex: Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when hydrocodone bitartrate and acetaminophen oral solution is used postoperatively and in patients with pulmonary disease." ], "storage_and_handling": [ "Storage Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Dispense the enclosed Patient Information Leaflet. A Schedule CIII Narcotic. PHARMACIST:" ], "pharmacokinetics": [ "Pharmacokinetics: The behavior of the individual components is described below: Hydrocodone: Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β- hydroxymetabolites. See for toxicity information. OVERDOSAGE Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See for toxicity information. OVERDOSAGE", "Hydrocodone: Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β- hydroxymetabolites. See for toxicity information. OVERDOSAGE", "Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See for toxicity information. OVERDOSAGE" ], "indications_and_usage": [ "INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen oral solution is indicated for the relief of moderate to moderately severe pain." ], "set_id": "484a2b25-77aa-48d6-ac7f-2dcca0771505", "id": "21db67fa-0781-4ddf-9f3a-febca4349543", "description_table": [ "
Per 5 mL Per 15 mL
Hydrocodone Bitartrate ................................. 2.5 mg 7.5 mg
Acetaminophen ............................................. 167 mg 500 mg
Alcohol ........................................................... 7% 7%
" ], "teratogenic_effects": [ "Teratogenic Effects:", "Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Hydrocodone bitartrate and acetaminophen oral solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." ], "dosage_and_administration_table": [ "
BODY WEIGHT APPROXIMATE AGE DOSE Every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE (6 doses per day)
12 to 15 kg (27 to 34 lbs.) 2 to 3 years ¾ teaspoonful = 3.75 mL 4½ teaspoonfuls = 22.5 mL
16 to 22 kg (35 to 50 lbs.) 4 to 6 years 1 teaspoonful = 5 mL 6 teaspoonfuls = 30 mL
23 to 31 kg (51 to 69 lbs.) 7 to 9 years 1½ teaspoonfuls = 7.5 mL 9 teaspoonfuls = 45 mL
32 to 45 kg (70 to 100 lbs.) 10 to 13 years 2 teaspoonfuls = 10 mL 12 teaspoonfuls = 60 mL
46 kg and up (101 lbs. and up) 14 years to adult 1 Tablespoonful = 15 mL 6 Tablespoonfuls = 90 mL
" ], "pediatric_use": [ "Pediatric Use: Safety and effectiveness in the pediatric population below the age of two years have not been established. Use of hydrocodone bitartrate and acetaminophen oral solution in the pediatric population is supported by the evidence from adequate and well-controlled studies of hydrocodone and acetaminophen combination products in adults, with additional data which support the development of metabolic pathways in children two years of age and over (See for pediatric dosage information). DOSAGE AND ADMINISTRATION" ], "inactive_ingredient": [ "In addition, the liquid contains the following inactive ingredients: D&C Yellow #10, ethyl maltol, FD&C Yellow #6, flavors, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution 70%, and sucrose. May also contain citric acid and sodium hydroxide." ], "contraindications": [ "CONTRAINDICATIONS This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Misuse, Abuse, and Diversion of Opioids: Hydrocodone bitartrate and acetaminophen oral solution contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Hydrocodone bitartrate and acetaminophen oral solution, and other opioids, used in analgesia can be abused and are subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common. “Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Hydrocodone bitartrate and acetaminophen oral solution, like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.", "Misuse, Abuse, and Diversion of Opioids: Hydrocodone bitartrate and acetaminophen oral solution contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Hydrocodone bitartrate and acetaminophen oral solution, and other opioids, used in analgesia can be abused and are subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common. “Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Hydrocodone bitartrate and acetaminophen oral solution, like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs." ], "warnings": [ "WARNINGS Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well. Hypersensitivity/anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Hydrocodone Bitartrate and Acetaminophen Oral Solution immediately and seek medical care if they experience these symptoms. Do not prescribe for patients with acetaminophen allergy. Hydrocodone Bitartrate and Acetaminophen Oral Solution Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Infants may have increased sensitivity to the respiratory depressant effects of opioids (See ). If use of hydrocodone bitartrate and acetaminophen oral solution in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring. PRECAUTIONS, Pediatric Use Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries. Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Misuse, Abuse, and Diversion of Opioids: Hydrocodone bitartrate and acetaminophen oral solution contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion. Hydrocodone bitartrate and acetaminophen oral solution can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and acetaminophen oral solution in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE ).", "Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.", "Hypersensitivity/anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Hydrocodone Bitartrate and Acetaminophen Oral Solution immediately and seek medical care if they experience these symptoms. Do not prescribe for patients with acetaminophen allergy. Hydrocodone Bitartrate and Acetaminophen Oral Solution", "Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Infants may have increased sensitivity to the respiratory depressant effects of opioids (See ). If use of hydrocodone bitartrate and acetaminophen oral solution in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring. PRECAUTIONS, Pediatric Use", "Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries.", "Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions." ], "pregnancy": [ "Pregnancy: Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Hydrocodone bitartrate and acetaminophen oral solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. These signs usually appear during the first few days of life. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal." ], "nursing_mothers": [ "Nursing Mothers: Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE HYDROCODONE ACETAMINOPHEN ACETAMINOPHEN CITRIC ACID MONOHYDRATE D&C YELLOW NO. 10 ETHYL MALTOL FD&C YELLOW NO. 6 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM HYDROXIDE SORBITOL SUCROSE clear, yellow tropical blend and orange-pineapple" ], "boxed_warning": [ "BOXED WARNING Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.", "Hydrocodone bitartrate and acetaminophen oral solution is used to relieve moderate to moderately severe pain. You should not take hydrocodone bitartrate and acetaminophen oral solution if you are allergic to hydrocodone or acetaminophen. The most common side effects of hydrocodone bitartrate and acetaminophen oral solution are abdominal pain, dizziness, drowsiness, light-headedness, nausea, shortness of breath, unusual tiredness, and vomiting. Take this medicine as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered." ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions: Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose-related. The usual adult dosage is one tablespoonful every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 6 tablespoonfuls. The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.27 mL/kg of hydrocodone bitartrate and acetaminophen oral solution (providing 0.135 mg/kg of hydrocodone bitartrate and 9 mg/kg of acetaminophen). Dosing should be based on weight whenever possible. BODY WEIGHT APPROXIMATE AGE DOSE Every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE (6 doses per day) 12 to 15 kg (27 to 34 lbs.) 2 to 3 years ¾ teaspoonful = 3.75 mL 4½ teaspoonfuls = 22.5 mL 16 to 22 kg (35 to 50 lbs.) 4 to 6 years 1 teaspoonful = 5 mL 6 teaspoonfuls = 30 mL 23 to 31 kg (51 to 69 lbs.) 7 to 9 years 1½ teaspoonfuls = 7.5 mL 9 teaspoonfuls = 45 mL 32 to 45 kg (70 to 100 lbs.) 10 to 13 years 2 teaspoonfuls = 10 mL 12 teaspoonfuls = 60 mL 46 kg and up (101 lbs. and up) 14 years to adult 1 Tablespoonful = 15 mL 6 Tablespoonfuls = 90 mL The total daily dosage for children should not exceed 6 doses per day. It is of utmost importance that the dose of hydrocodone bitartrate and acetaminophen oral solution be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that caregivers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage." ], "adverse_reactions": [ "ADVERSE REACTIONS Potential effects of high dosage are also listed in the section. OVERDOSAGE Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension. Cardio-renal: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma. Central Nervous System/Psychiatric: Hypoglycemic coma. Endocrine: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting. Gastrointestinal System: Spasm of vesical sphincters, ureteral spasm, and urinary retention. Genitourinary System: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia. Hematologic: Allergic reactions. Hypersensitivity: Skeletal muscle flaccidity. Musculoskeletal: Acute airway obstruction, apnea, dose-related respiratory depression (See ), shortness of breath. Respiratory Depression: OVERDOSAGE Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Special Senses: Cold and clammy skin, diaphoresis, pruritus, rash. Skin:" ], "spl_unclassified_section": [ "CIII Rx only", "Manufactured for: Huntsville, AL 35811 QUALITEST PHARMACEUTICALS 8082888 R 5/11-R4" ], "laboratory_tests": [ "Laboratory Tests: In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests." ], "information_for_patients": [ "Information for Patients/Caregivers: Do not take Hydrocodone Bitartrate and Acetaminophen Oral Solution if you are allergic to any of its ingredients. If you develop signs of allergy such as a rash or difficulty breathing stop taking Hydrocodone Bitartrate and Acetaminophen Oral Solution and contact your healthcare provider immediately. Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose. Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product, and should be avoided. Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Physicians should instruct patients and caregivers to read the patient information leaflet, which appears as the last section of the labeling." ], "package_label_principal_display_panel": [ "HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION Label Image" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding. The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Pharmacokinetics: The behavior of the individual components is described below: Hydrocodone: Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β- hydroxymetabolites. See for toxicity information. OVERDOSAGE Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See for toxicity information. OVERDOSAGE" ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility: No adequate studies have been conducted in animals to determine whether hydrocodone has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Hydrocodone has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Acetaminophen has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow." ], "nonteratogenic_effects": [ "Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. These signs usually appear during the first few days of life. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal." ], "spl_patient_package_insert_table": [ "
BODY WEIGHT APPROXIMATE AGE DOSE Every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE (6 doses per day)
12 to 15 kg (27 to 34 lbs.) 2 to 3 years ¾ teaspoonful = 3.75 mL 4½ teaspoonfuls = 22.5 mL
16 to 22 kg (35 to 50 lbs.) 4 to 6 years 1 teaspoonful = 5 mL 6 teaspoonfuls = 30 mL
23 to 31 kg (51 to 69 lbs.) 7 to 9 years 1½ teaspoonfuls = 7.5 mL 9 teaspoonfuls = 45 mL
32 to 45 kg (70 to 100 lbs.) 10 to 13 years 2 teaspoonfuls = 10 mL 12 teaspoonfuls = 60 mL
46 kg and up (101 lbs. and up) 14 years to adult 1 Tablespoonful = 15 mL 6 Tablespoonfuls = 90 mL
" ], "overdosage": [ "OVERDOSAGE Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Signs and Symptoms: : Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. Hydrocodone : In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Acetaminophen Treatment: A single or multiple drug overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional Poison Control Center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For hydrocodone overdose, primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydrocodone. Since the duration of action of hydrocodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.", "Signs and Symptoms: : Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. Hydrocodone : In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Acetaminophen", "Treatment: A single or multiple drug overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional Poison Control Center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For hydrocodone overdose, primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydrocodone. Since the duration of action of hydrocodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication." ] }, { "effective_time": "20110209", "inactive_ingredient": [ "Non-Medicinal ingredients: sodium saccharin, sodium benzoate, plasdone C30, glycerin USP, propylene glycol, polysorbate 20, stepanol WA 100, phosphoric acid, purified water, raspberry flavor" ], "spl_product_data_elements": [ "Denti-Care Topical Fluoride Foam Raspberry Fluoride Ions sodium fluoride FLUORIDE ION HYDROFLUORIC ACID FLUORIDE ION" ], "description": [ "Denti-Care Denti-Foam Topical Fluoride Foam Raspberry 1.23 % Fluoride Ions 4.4 oz / 125 g NDC 64778-1378-1" ], "warnings_and_cautions": [ "Warnings: KEEP OUT OF REACH OF CHILDREN Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate. Do not use if seal is broken. Rx Only" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "A topical anti-caries preparation Directions (for professional use only): 1. Use after thorough prophylaxis 2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s) Note: fill tray(s) at one quarter full to allow foam to expand 3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes 4. Remove tray(s) and have patient expectorate excess 5. Advise patient not to eat, drink or rinse for 30 minutes after the application 130 applications Medicinal ingredients: Fluoride ions 1.23 % w/w (from 1.76 % sodium fluoride and 1.04% hydrofluoric acid)" ], "spl_unclassified_section": [ "Manufactured in Canada for AR Medicom Inc Montreal, Canada, H8T 3J8 Questions 1-800-361-2862 or www.medicom.com UPC 686864018704 Item code 10037-RB Rev 00" ], "package_label_principal_display_panel": [ "10037foamrb" ], "set_id": "4a7ea46a-9799-418d-b277-550e9f0a0612", "id": "0ef082fc-d68a-432b-adbf-dc67a578f3ad" }, { "spl_product_data_elements": [ "Infants Silapap Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 METHYLPARABEN SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE PROPYLENE GLYCOL WATER wild cherry" ], "active_ingredient": [ "Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)" ], "purpose": [ "Purpose: Fever reducer/pain reliever" ], "indications_and_usage": [ "Uses temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■the common cold ■flu ■toothaches ■sore throat ■headaches" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Sore throat warning : if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "do_not_use": [ "Do not use with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin." ], "when_using": [ "When using this product do not exceed recommended dosage. (see overdose warning)" ], "stop_use": [ "Stop use and ask a doctor if ■ new symptoms occur ■ redness or swelling is present ■ pain gets worse or lasts for more than 5 days ■ fever gets worse or lasts for more than 3 days. These could be signs of serious condition." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away, (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions ■ this product does not contain directions or complete warnings for adult use ■ do not give more than directed (see overdose warning) ■ find right dose on chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■ dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■ If needed, repeat dose every 4 hours ■ do not give more than 5 times in 24 hours ■ Replace dropper tightly to maintain child resistance Weight (lb) Age (yr) Dose (mL) under 24 under 2 years ask a doctor 24-35 2-3 years 1.6 mL (0.8 + 0.8 mL) For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb. Other information Store between 20° - 25°C (68° - 77°F)" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (mL)
under 24 under 2 years ask a doctor
24-35 2-3 years 1.6 mL (0.8 + 0.8 mL)
" ], "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water." ], "questions": [ "Comments 1-888-974-5279 Manufactured by: Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave. Carmel , NY 10512" ], "package_label_principal_display_panel": [ "Carton" ], "set_id": "4c4ae7af-eacd-4b15-860c-d08305fce8e4", "id": "a9d64daf-cd20-4ae6-8d6f-8dfcf3792361", "effective_time": "20140627", "version": "17", "openfda": {} }, { "effective_time": "20100614", "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive Ingredient: Purified water.", "Inactive ingredients flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose" ], "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Use: For preparation of skin before injection.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporary relief of minor aches, pains and headaches to reduce fever associated with colds, sore throats, teething" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only.", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product." ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Wipe Injection site vigorously and discard." ], "spl_product_data_elements": [ "K-Mart SmartSense First Aid Contains 303 Pieces BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOTROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Chewable Aspirin ASPIRIN ASPIRIN ASPIRIN FD&C YELLOW NO. 6 SACCHARIN SODIUM CATION SILICON DIOXIDE STARCH, CORN STEARIC ACID SUCROSE ORANGE ASPIRIN Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B" ], "description": [ "LOT/EXP: Made in CHINA 20130301", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "LOT/EXP: Made in CHINA 20140301", "Made in CHINA LOT/EXP:", "MADE IN USA Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "ask_doctor": [ "Ask a doctor before use if you have; asthma stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems a child experiencing arthritis pain if you are; allergic to aspirin taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions Do not use more than directed Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours, Do not exceed 48 tablets in 24 hours unless directed by a doctor. Children Under 12 years: Consult a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and ask a doctor if; an allergic reaction occurs, Seek medical help right away pain or fever persists new or unexpected symptoms occur redness or swelling is present ringing in ears or loss of hearing occurs" ], "storage_and_handling": [ "Other Information: Store at room temperature", "Other information: Store at room temperature.", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Flammable - keep away from fire or flame.", "Store at room temperature tamper evident sealed packets do not use any opened or torn packets" ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: with electrocautery, in the eyes.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you are allergic to aspirin or any other pain relievers/fever reducers for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor for at least 7 days after a tonsillectomy or oral surgery" ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Antiseptic Towelette", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "GenuineTripleAntibiotic", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "GenuineEyeWash", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AlcoholCleansingPad", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "2 Tablets GENUINE FIRST AID. Chewable Aspirin 81mg", "Chewable Aspirin 81mg", "SmartSense Clean Treat Protect FIRST AID KIT HOME PLAY AUTO OFFICE WORK All Purpose Kit with 6 First Aid Pockets for Cleaning and Treating: Small or Medium Cuts and Scratches Severe Bleeding and Burns Including a CPR Breather Barrier 303 PIECES CARRYING CASE 1 Soft-side Bag 1 Easy Access Pocket System POCKET 1: SMALL CUTS AND BURNS 25 Adhesive Plastic Bandages 3/4\"x3\" 155 Junior Plastic Bandages 3/8\"x1-1/2\" 3 Adhesive Plastic Bandages 1\"x3\" 1 Knuckle Fabric Bandage 50 Adhesive Spot Bandages 7/8\"x7/8\" 1 Fingertip Fabric Bandage 1 Elbow/Knee Adhesive Bandage 1 Burn Cream 4 Antiseptic Towelettes 1 Triple Antibiotic Ointment 0.5gr 1 Sterile Gauge Pads 2\"x2\" 20 Cotton Tipped Applicators POCKET 2: MEDIUM CUTS AND SCRATCHES 4 Antiseptic Towelettes 1 Sterile Gauze Pad 2\"x2\" 1 Pressure Bandage 2\"X2\" 1 Pressure Bandage 3\"X3\" 1 Sterile Eye Pads 1 Sterile Eye Wash 10ml 2 Butterfly Wound Closures POCKET 3: SEVERE BLEEDING AND SCRATCHES 1 First Aid Tape Roll 1/2\"x2.5 yds. 1 Bloodstopper Dressing POCKET 4: CPR 1 CPR Breathing Barrier POCKET 5 PROTECTION 2 Medical Grade Gloves 1 Instant Cold Compress 5 Alcohol Cleansing Pads 1 Insect Sting Relief Pads 1 Emergency Blanket 38\"x60\" 2 Chewable Aspirin Tablets 1 Triangular Bandage 42\"x42\"x59\" POCKET 6: INSTRUMENTS 1 Emergency First Aid Guide 1 Plastic Tweezers 1 Scissors 6 Assorted Safety Pins 2 Wooden Finger Splints KM-R303 Made in China Distributed by: Kmart Corporation Hoffman Estates, IL 60179 Shop kmart.com PLEASE RECYCLE SATISFACTION GUARANTEE Thank you for purchasing this quality product. If you are unsatisfied for any reason, return the unused portion to the store for a full refund or call 1-800-842-7886.", "K Mart SmartSense Kit 303" ], "set_id": "4cb810be-65e2-4f3c-a56f-e48e37cb9449", "id": "075459e9-2adb-44b5-a8c6-99c05ff35a08", "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID*). . . . . . . . . . . . . Analgesic/Antipyretic *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100617", "purpose": [ "Active ingredients (in each 15 ml tablespoon) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 200 mg Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-800-342-6844 www.vicks.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains sodium 28 mg store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves cough due to the common cold helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus" ], "set_id": "4e08255e-ae1f-41e0-8ad0-212613626b5e", "id": "577adb89-748a-4f4c-b779-8b041b6bc363", "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 200 mg Expectorant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 TBSP (15 ml) every 4 hours
children 6 to under 12 years 1½ tsp (7½ ml) every 4 hours
children under 6 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, carboxymethylcellulose sodium, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, polyethylene oxide, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate" ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Vicks 44 E Cough and Chest Congestion Relief Dextromethorphan Hydrobromide and Guaifenesin Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin" ], "ask_doctor": [ "Ask a doctor before use if you have a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use dose cup, teaspoon (tsp), or tablespoon (TBSP) do not exceed 6 doses per 24 hours adults and children 12 years and over 1 TBSP (15 ml) every 4 hours children 6 to under 12 years 1½ tsp (7½ ml) every 4 hours children under 6 years ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each 15 ml tablespoon) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 200 mg Expectorant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label NON- DROWSY VICKS ® FORMULA 44 E EXPECTORANT Cough & Chest Congestion Relief Cough Suppressant...Expectorant 6 FL OZ (177 ml) Alcohol 5% PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 15 ml tablespoon) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 200 mg Expectorant
" ] }, { "effective_time": "20130305", "drug_interactions": [ "Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction.", "Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.", "Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose.", "Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution.", "Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly." ], "geriatric_use": [ "Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "abuse": [ "Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence." ], "precautions": [ "PRECAUTIONS Animal reproduction studies have not been conducted with the drug combination-promethazine and codeine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine hydrochloride and codeine phosphate should be given to a pregnant woman only if clearly needed. General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see and ). WARNINGS -CNS Depression PRECAUTIONS-Drug Interactions Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Advise patients that some people have a genetic variation that results in codeine changing into morphine more rapidly and completely than other people. Most people are unaware of whether they are an ultra-rapid codeine metabolizer or not. These higher-than-normal levels of morphine in the blood may lead to life-threatening or fatal respiratory depression or signs of overdose such as extreme sleepiness, confusion, or shallow breathing. Children with this genetic variation who were prescribed codeine after tonsillectomy and/or adenoidectomy for obstructive sleep apnea may be at greatest risk based on reports of several deaths in this population due to respiratory depression. As a result, codeine is contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Advise caregivers of children receiving codeine for other reasons to monitor for signs of respiratory depression. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services). Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine. Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the assay. Promethazine was nonmutagenic in the test system of Ames. Salmonella Salmonella Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see ). OVERDOSAGE Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown. Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see ). WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman. Pediatric Use: see and The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( WARNINGS – Box Warning ). Use In Pediatric Patients Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in these patients (see and ). WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine CONTRAINDICATIONS The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see ). WARNINGS-Use in Pediatric Patients Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "description": [ "DESCRIPTION Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C H NO •H PO •½H O, and the following structural formula: 18 21 3 3 4 2 Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C H N S•HCI, and the following structural formula: 17 20 2 This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine.", "Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C H NO •H PO •½H O, and the following structural formula: 18 21 3 3 4 2 Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C H N S•HCI, and the following structural formula: 17 20 2 This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine." ], "labor_and_delivery": [ "Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see ). OVERDOSAGE Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown." ], "general_precautions": [ "General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP." ], "indications_and_usage": [ "INDICATIONS AND USAGE Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold." ], "dependence": [ "Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "set_id": "4e0d550e-6281-48ce-819f-ca37fcca53e0", "id": "482db043-19a2-486d-9dee-63a1fe4d49fc", "teratogenic_effects": [ "Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.", "Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known.", "Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." ], "pediatric_use": [ "Use In Pediatric Patients The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. The association does not directly relate to individualized weight-based dosing, which might otherwise permit safe administration. Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in these patients (see and ). WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine CONTRAINDICATIONS Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl. OVERDOSAGE", "Pediatric Use: see and The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( WARNINGS – Box Warning ). Use In Pediatric Patients Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme CYP2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in these patients (see and ). WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine CONTRAINDICATIONS The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see ). WARNINGS-Use in Pediatric Patients" ], "inactive_ingredient": [ "Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose." ], "contraindications": [ "CONTRAINDICATIONS The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. Codeine sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. Codeine is contraindicated in patients with a known hypersensitivity to the drug. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance. Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence. Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "warnings": [ "WARNINGS The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Respiratory Depression in Children Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Codeine: Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine (see ). Death Related to Ultra-Rapid Metabolism of Codeine to Morphine PRECAUTIONS -Nursing Mothers Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) (see ). OVERDOSAGE Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy (see ). CONTRAINDICATIONS When prescribing codeine-containing drugs, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose. : Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine Codeine may cause or aggravate constipation. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. CONTRAINDICATIONS Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients. Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see and ). PRECAUTIONS - Information For Patients Drug Interactions Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Respiratory Depression in Children Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Codeine: Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine (see ). Death Related to Ultra-Rapid Metabolism of Codeine to Morphine PRECAUTIONS -Nursing Mothers Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) (see ). OVERDOSAGE Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine is contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy (see ). CONTRAINDICATIONS When prescribing codeine-containing drugs, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose. : Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine Codeine may cause or aggravate constipation. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. CONTRAINDICATIONS Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.", "Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. CONTRAINDICATIONS", "Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see and ). PRECAUTIONS - Information For Patients Drug Interactions Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see and ). PRECAUTIONS - Information For Patients Drug Interactions", "Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.", "Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.", "Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents.", "Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Other Considerations Administration of promethazine has been associated with reported cholestatic jaundice." ], "pregnancy": [ "Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "nursing_mothers": [ "Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see ). WARNINGS - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman." ], "spl_product_data_elements": [ "Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate PROMETHAZINE HYDROCHLORIDE PROMETHAZINE CODEINE PHOSPHATE CODEINE ANHYDROUS ALCOHOL ASCORBIC ACID ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 3 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE grape blend flavor" ], "boxed_warning": [ "WARNING: Respiratory Depression in Children and Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory Depression in Children The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism." ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine.", "Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.", "Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine." ], "openfda": {}, "controlled_substance": [ "Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance." ], "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. It is important that promethazine with codeine syrup is measured with an accurate measuring device (see ). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. PRECAUTIONS-Information For Patients The average effective dose for adults and children 12 years of age and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours. The average effective dose for children 6 years to under 12 years of age is 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours." ], "adverse_reactions": [ "ADVERSE REACTIONS Codeine: Nervous System – CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions. Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics). Gastrointestinal – Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported. Genitourinary – Oliguria, urinary retention; antidiuretic effect has been reported (common to narcotic analgesics). Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema. Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness. Promethazine: Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported. Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic – Dermatitis, photosensitivity, urticaria. Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Gastrointestinal – Dry mouth, nausea, vomiting, jaundice. Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See .) WARNINGS - Promethazine; Respiratory Depression Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See .) WARNINGS - Promethazine; Neuroleptic Malignant Syndrome Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCI. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients." ], "spl_unclassified_section": [ "CV Rx only", "Manufactured for: Huntsville, AL 35811 QUALITEST PHARMACEUTICALS 8181652 R2/13-R5" ], "information_for_patients": [ "Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see and ). WARNINGS -CNS Depression PRECAUTIONS-Drug Interactions Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Advise patients that some people have a genetic variation that results in codeine changing into morphine more rapidly and completely than other people. Most people are unaware of whether they are an ultra-rapid codeine metabolizer or not. These higher-than-normal levels of morphine in the blood may lead to life-threatening or fatal respiratory depression or signs of overdose such as extreme sleepiness, confusion, or shallow breathing. Children with this genetic variation who were prescribed codeine after tonsillectomy and/or adenoidectomy for obstructive sleep apnea may be at greatest risk based on reports of several deaths in this population due to respiratory depression. As a result, codeine is contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Advise caregivers of children receiving codeine for other reasons to monitor for signs of respiratory depression. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services)." ], "package_label_principal_display_panel": [ "PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP Label Image" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours. Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. 1 Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.", "Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours.", "Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. 1 Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the assay. Promethazine was nonmutagenic in the test system of Ames. Salmonella Salmonella" ], "nonteratogenic_effects": [ "Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "overdosage": [ "OVERDOSAGE Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates. Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur. Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful.", "Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates.", "Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur.", "Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful." ] }, { "effective_time": "20100514", "inactive_ingredient": [ "Inactive ingredients butylparaben, citric acid, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "when_using": [ "When using this product, do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage." ], "spl_product_data_elements": [ "QPAP Infants Drops acetaminophen ACETAMINOPHEN ACETAMINOPHEN BUTYLPARABEN CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 GLYCERIN POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE clear, orange" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use find right dose on chart. (If possible, use weight to dose; otherwise, use age.) use only enclosed dropper for use with this product. Do not use any other dosing device. fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek if needed, repeat dose every 4 hours while symptoms last do not use more than 5 times in 24 hours replace dropper tightly to maintain child resistance Weight (lbs) Age (yrs) Dose (mL) under 24 under 2 ask a doctor 24-35 2-3 1.6 mL (0.8+0.8 mL) Attention: Specifically designed for use with enclosed dropper. Use only enclosed dropper to dose this product. Do not use any other dosing device." ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "spl_unclassified_section": [ "Other information store at 15° to 30°C (59° to 86°F) You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.", "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev. 6/09 R10 8273411 0838" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is an image of the carton for the Q-PAP Infant's Drops." ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headaches sore throat toothaches" ], "set_id": "4ed0f91d-918f-4179-8ba9-86b09889dbec", "id": "5c319a28-be1c-4ede-8ffd-1fe85ab717ee", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "overdosage": [ "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen, USP 80 mg" ], "dosage_and_administration_table": [ "
Weight (lbs) Age (yrs) Dose (mL)
under 24 under 2 ask a doctor
24-35 2-3 1.6 mL (0.8+0.8 mL)
" ] }, { "effective_time": "20131230", "purpose": [ "Purpose Nighttime sleep-aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? 1-732-249-6363" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information each 30 mL dose (2 tablespoons) contains: sodium 21 mg store at room temperature protect from light. Does not meet USP <671>." ], "indications_and_usage": [ "Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep" ], "set_id": "5089fd55-d51b-4bc9-aa05-cbc175c40e04", "id": "469b51ca-4778-4366-8e00-6805fcb1469b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid" ], "active_ingredient": [ "Active ingredient (in each 30 mL or 2 tablespoons) Diphenhydramine HCl 50 mg" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor
" ], "inactive_ingredient": [ "Inactive ingredients citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol" ], "warnings": [ "Warnings Do not use for children under 12 years of age with any other product containing Diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid When using this product avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "Nighttime Sleep Aid Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Sodium Benzoate Citric Acid Monohydrate Sorbitol Saccharin Sodium Alcohol FD&C RED NO. 40 Sodium Citrate Glycerin FD&C Blue NO. 1 Water Dark" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only one dose per day (24 hours) – see Overdose warning use dose cup or tablespoon adults & children 12 yrs & over One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor" ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118" ], "stop_use": [ "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness." ], "do_not_use": [ "Do not use for children under 12 years of age with any other product containing Diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label NDC 55315-003-12 fred's ® Warming Berry Flavor Nighttime Sleep-Aid Diphenhydramine HCl Non-Habit Forming Not for treating Cold or Flu Alcohol 10% See Warnings 6 FL OZ (177 mL) fred's LAB TESTED Lab Tested for Quality Fred Tested for Satisfaction Compare To Vicks ZzzQuil ® * Principal Display Panel - 177 mL Bottle Label" ] }, { "effective_time": "20110209", "inactive_ingredient": [ "Inactive ingredients citric acid, D&C red no. 33, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, and purified water." ], "purpose": [ "Purpose: Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 5 of the recommended doses per day with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Do not use with any other product containing acetaminophen. When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 5 days fever gets worse or lasts for more than 3 days Keep out of reach of children. Overdose Warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs of symptoms." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning)" ], "questions": [ "Questions 888-974-5279 This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol ® . Manufactured by: Silarx Pharmaceuticals, Inc 19 West Street Spring Valley, NY 10977 USA Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320" ], "spl_product_data_elements": [ "Childrens Silapap Acetaminophen Acetaminophen Acetaminophen anhydrous citric acid D&C red no. 33 FD&C red no. 40 methylparaben propylene glycol saccharin sodium sodium benzoate water cherry flavor" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning). if needed, repeat dose every 4 hours or as directed by a doctor do not give more than 5 doses in 24 hours children under 2 yrs (under 24 lbs) ask a doctor children 2-3 years (24-35 lbs) 1 teaspoonful (5 mL) children 4-5 years (36-47 lbs) 1 1/2 teaspoonfuls (7.5 mL) children 6-8 years (48-59 lbs) 2 teaspoonfuls (10 mL) children 9-10 years (60-71 lbs) 2 1/2 teaspoonfuls (12.5 mL) children 11 years (72-95 lbs) 3 teaspoonfuls (15 mL) adults & children 12 years & older 4 teaspoonfuls (20 mL) Other information Store at room temperature 20°-25°C (68°-77°F)" ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 5 days fever gets worse or lasts for more than 3 days" ], "do_not_use": [ "Do not use with any other product containing acetaminophen." ], "package_label_principal_display_panel": [ "Acetaminophen 180mg / 5ml" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache temporarily reduces fever" ], "set_id": "50fca3de-4703-4eb7-8294-1ce8e860a100", "id": "50fca3de-4703-4eb7-8294-1ce8e860a100", "overdosage": [ "Overdose Warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs of symptoms." ], "active_ingredient": [ "Active Ingredient: Acetaminophen 160 mg (in each 5 mL = 1 teaspoonful)" ], "dosage_and_administration_table": [ "
children under 2 yrs (under 24 lbs) ask a doctor
children 2-3 years (24-35 lbs) 1 teaspoonful (5 mL)
children 4-5 years (36-47 lbs) 1 1/2 teaspoonfuls (7.5 mL)
children 6-8 years (48-59 lbs) 2 teaspoonfuls (10 mL)
children 9-10 years (60-71 lbs) 2 1/2 teaspoonfuls (12.5 mL)
children 11 years (72-95 lbs) 3 teaspoonfuls (15 mL)
adults & children 12 years & older 4 teaspoonfuls (20 mL)
" ] }, { "effective_time": "20120418", "purpose": [ "Purpose Brompheniramine Maleate Antihistamine Pseudoephedrine HCl Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately." ], "when_using": [ "When using this product ∙ drowsiness may occur ∙ avoid alcoholic beverages ∙ alcohol, sedatives, and tranquilizers may increase drowsiness ∙ be careful when driving a motor vehicle or operating machinery ∙ excitability may occur, especially in children" ], "questions": [ "Questions or Comments? Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com ." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ∙ ask a health professional before use." ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever (allergic rhinitis): ∙ runny nose ∙ sneezing ∙ itchy, watery eyes ∙ itching of the nose or throat ∙ Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis. ∙ Temporarily restores freer breathing through the nose" ], "set_id": "5363f476-dbf2-4d8d-8056-2699e39f1662", "id": "78e4a0be-9d00-4884-ab04-95100f8afb2b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are ∙ taking any other nasal decongestant or stimulant ∙ taking sedatives or tranquilizers" ], "active_ingredient": [ "Active Ingredients In each 5 mL (1 teaspoonful) clear, cherry flavored liquid Brompheniramine maleate, USP 4 mg Pseudoephedrine HCl, USP 20 mg" ], "dosage_and_administration_table": [ "
Age Dose
Adults and children over 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours
Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 to 6 hours
Children under 6 years of age Ask your doctor
" ], "inactive_ingredient": [ "Inactive Ingredients Benzoic acid, bitter masking agent, cherry flavoring, citric acid, glycerin, polyethylene glycol, purified water, saccharin sodium, and sorbitol solution" ], "warnings": [ "Warnings Do not exceed recommended dosage." ], "spl_product_data_elements": [ "LoHist PSB Brompheniramine Maleate and Pseudoephedrine Hydrochloride BROMPHENIRAMINE MALEATE BROMPHENIRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE BENZOIC ACID ANHYDROUS CITRIC ACID GLYCERIN POLYETHYLENE GLYCOL 400 WATER SACCHARIN SODIUM SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if you have ∙ heart disease ∙ high blood pressure ∙ thyroid disease ∙ diabetes ∙ glaucoma ∙ trouble urinating due to an enlarged prostate gland ∙ a breathing problem such as emphysema or chronic bronchitis" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Do not exceed 6 doses in a 24-hour period Age Dose Adults and children over 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 to 6 hours Children under 6 years of age Ask your doctor Other Information store at 20°-25°C (68°-77°F)" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if ∙ nervousness, dizziness, or sleeplessness occur ∙ symptoms do not improve within 7 days, or are accompanied by fever" ], "do_not_use": [ "Do not use ∙ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel Figure 1: Product Label (front side) 78e4a0be-figure-01" ] }, { "effective_time": "20110209", "inactive_ingredient": [ "Inactive ingredients caramel powder, citric acid, corn syrup, FD&C red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "purpose": [ "" ], "warnings": [ "Warnings Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "1-800-645-2158, 9 am – 5 pm ET, Monday – Friday" ], "spl_product_data_elements": [ "Cough Guaifenesin Guaifenesin Guaifenesin Caramel Citric Acid Monohydrate Corn Syrup FD&C RED NO. 40 Glycerin Menthol Propylene Glycol Water Sodium Benzoate Saccharin Sodium Reddish-Pink" ], "ask_doctor": [ "Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take every four hours do not take more than 6 doses in 24 hours adults and children 12 years and over 2–4 teaspoonfuls children 6 to under 12 years 1–2 teaspoonfuls children under 6 years do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each teaspoonful contains: sodium 3 mg store at room temperature 15°–30°C (59°–86°F)" ], "do_not_use": [ "TAMPER EVIDENT DO NOT USE IF INNER FOIL SEAL OVER MOUTH OF BOTTLE IS BROKEN OR MISSING" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label Rebel Distributors Corp NDC 21695-705-04 FOR ADULTS AND CHILDREN NON-NARCOTIC EXPECTORANT ALCOHOL FREE Cough SYRUP Guaifenesin, USP 4 fl oz (118 mL) Guaifenesin 100mg/5ml" ], "indications_and_usage": [ "Uses helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus" ], "set_id": "5379a585-584d-45f5-9113-dffc277d5876", "id": "5379a585-584d-45f5-9113-dffc277d5876", "active_ingredient": [ "Active ingredient (in each 5 mL teaspoonful) Guaifenesin 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2–4 teaspoonfuls
children 6 to under 12 years 1–2 teaspoonfuls
children under 6 years do not use
" ] }, { "effective_time": "20120628", "purpose": [ "Purpose Brompheniramine Maleate Antihistamine Chlophedianol HCl Antitussive Phenylephrine HCl Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately." ], "when_using": [ "When using this product ∙ drowsiness may occur ∙ avoid alcoholic beverages ∙ alcohol, sedatives, and tranquilizers may increase drowsiness ∙ be careful when driving a motor vehicle or operating machinery ∙ excitability may occur, especially in children" ], "questions": [ "Questions or Comments Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5 CST)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ∙ ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: ∙ cough due to minor throat and bronchial irritation ∙ runny nose ∙ sneezing ∙ itchy, watery eyes ∙ itching of the nose or throat ∙ nasal congestion ∙ reduces swelling of nasal passages" ], "set_id": "55521596-a718-4c62-989c-c9dbdceea978", "id": "1baab94f-0515-494f-b621-9a0c7688a484", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are ∙ taking any other nasal decongestant or stimulant ∙ taking sedatives or tranquilizers" ], "active_ingredient": [ "Active Ingredients In each 5 mL (1 teaspoonful) bubblegum flavored liquid Brompheniramine Maleate, USP 4 mg Chlophedianol HCL, USP 25 mg Phenylephrine HCl, USP 10 mg" ], "dosage_and_administration_table": [ "
Age Dose
Adults and children over 12 years of age 1 teaspoonful (5 mL) every 6 hours
Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 6 hours
Children under 6 years of age Consult a physician
" ], "inactive_ingredient": [ "Inactive Ingredients benzoic acid, bubblegum flavor, citric acid, edetate disodium USP, glycerin, propylene glycol, purified water, saccharin sodium, sodium citrate dihydrate, and sorbitol" ], "warnings": [ "Warnings Do not exceed recommended dosage." ], "spl_product_data_elements": [ "Trexbrom Brompheniramine Maleate / Chlophedianol Hydrochloride / Phenylephrine Hydrochloride BROMPHENIRAMINE MALEATE BROMPHENIRAMINE CHLOPHEDIANOL HYDROCHLORIDE CHLOPHEDIANOL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZOIC ACID ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM DIHYDRATE SODIUM CITRATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if you have ∙ heart disease ∙ high blood pressure ∙ thyroid disease ∙ diabetes ∙ glaucoma ∙ trouble urinating due to an enlarged prostate gland ∙ a breathing problem such as emphysema or chronic bronchitis ∙ a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema ∙ a cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Do not exceed 6 doses in a 24-hour period Age Dose Adults and children over 12 years of age 1 teaspoonful (5 mL) every 6 hours Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 6 hours Children under 6 years of age Consult a physician Other Information store at 20°-25°C (68°-77°F)" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if ∙ nervousness, dizziness, or sleeplessness occur ∙ cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use this product ∙ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug." ], "package_label_principal_display_panel": [ "Principal Display Panel Figure 1: 16 fl. oz. Bottle Label Figure 2: 4 fl. oz. Bottle Label Figure 3: 20 mL Bottle Label 1baab94f-figure-01 1baab94f-figure-02 1baab94f-figure-03" ] }, { "effective_time": "20140521", "inactive_ingredient": [ "Inactive Ingredients Liquid Sorbitol, Dental-Type Silica, Sodium Chloride, Sodium Lauryl sulphate, Sodium carboxymethylcellulose, Panthenol, Polyethylene Glycol 1500, Saccharin Sodium Hydrate, Phosphoric acid, Water" ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Dental Clinic 2080 K Strong Winter Green SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION POLYGLUCOSE SORBITOL CARBOXYMETHYL ETHER SILICA DIMETHYL SILYLATE SODIUM CHLORIDE SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM PANTHENOL POLYETHYLENE GLYCOL 1500 SACCHARIN SODIUM PHOSPHORIC ACID WATER Strong Winter Green" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow. supervise children as necessary until capable of using without supervision. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor. Children under 2 years of age: Consult a dentist or doctor." ], "spl_unclassified_section": [ "Dental Clinic 2080 K Toothpaste Strong Winter Green", "Dental Clinic 2080 Gingivalis Project K Gingivitis-causing Bacteria 99% Inhibits in-vitro test Results Tested by Dental School Clinic Dental Clinic 2080 K Toothpaste Citrus Cool Mint OTC Drug Customer Center:060-024-1357 (Nationwide Toll-Free) We accept returns in compliance with the Consumer Protection Act of Fair Trade Commission. AEKYUNG MADE IN KOREA www.aekyung.co.kr Net Weight: 100g" ], "package_label_principal_display_panel": [ "Dental Clinic 2080 K Toothpaste Strong Winter Green, 100g (67225-0002-1) StrongWinterGreen" ], "indications_and_usage": [ "Use Aids in the prevention of dental cavities." ], "set_id": "56d850af-24f7-4147-aa5f-05a1e4e6a8ab", "id": "7ae81c2f-2d34-41af-b1d4-14e7dd554a37", "active_ingredient": [ "Active Ingredient Sodium Fluoride 0.22% (0.1% w/v fluoride ion)" ] }, { "effective_time": "20120418", "purpose": [ "Purpose Brompheniramine Maleate Antihistamine Dextromethorphan HBr Antitussive Pseudoephedrine HCl Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately." ], "when_using": [ "When using this product ∙ drowsiness may occur ∙ avoid alcoholic beverages ∙ alcohol, sedatives, and tranquilizers may increase drowsiness ∙ be careful when driving a motor vehicle or operating machinery ∙ excitability may occur, especially in children" ], "questions": [ "Questions or Comments Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com ." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ∙ ask a health professional before use." ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever (allergic rhinitis): ∙ cough due to minor throat and bronchial irritation ∙ runny nose ∙ sneezing ∙ itchy, watery eyes ∙ itching of the nose or throat ∙ Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis. ∙ Temporarily restores freer breathing through the nose" ], "set_id": "587a8ecf-4abf-4859-b450-eddf247470cc", "id": "f690af31-cbc4-49ec-92ce-24d2bf29deb1", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are ∙ taking any other nasal decongestant or stimulant ∙ taking sedatives or tranquilizers" ], "active_ingredient": [ "Active Ingredients In each 5 mL (1 teaspoonful) clear, cherry flavored liquid Brompheniramine Maleate, USP 4 mg Dextromethorphan HBr, USP 20 mg Pseudoephedrine HCl, USP 20 mg" ], "dosage_and_administration_table": [ "
Age Dose
Adults and children over 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours
Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 to 6 hours
Children under 6 years of age Ask your doctor
" ], "inactive_ingredient": [ "Inactive Ingredients Benzoic acid, bitter masking agent, cherry flavoring, citric acid, glycerin, polyethylene glycol, purified water saccharin sodium, sorbitol solution" ], "warnings": [ "Warnings Do not exceed recommended dosage." ], "spl_product_data_elements": [ "LoHist PSB DM Brompheniramine Maleate, Dextromethorphan Hydrobromide and Pseudoephedrine Hydrochloride BROMPHENIRAMINE MALEATE BROMPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE BENZOIC ACID ANHYDROUS CITRIC ACID GLYCERIN POLYETHYLENE GLYCOL 400 WATER SACCHARIN SODIUM SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if you have ∙ heart disease ∙ high blood pressure ∙ thyroid disease ∙ diabetes ∙ glaucoma ∙ trouble urinating due to an enlarged prostate gland ∙ a breathing problem such as emphysema or chronic bronchitis ∙ a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema ∙ a cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Do not exceed 6 doses in a 24-hour period Age Dose Adults and children over 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 to 6 hours Children under 6 years of age Ask your doctor Other Information store at 20°-25°C (68°-77°F)" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if ∙ nervousness, dizziness, or sleeplessness occur ∙ cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use ∙ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug." ], "package_label_principal_display_panel": [ "Principal Display Panel Figure 1: 16 oz Bottle label f690af31-figure-01" ] }, { "effective_time": "20110818", "inactive_ingredient": [ "Inactive ingredients- calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium lauryl sulfate, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum." ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 yrs of age." ], "warnings": [ "If more than is used for brushing is accidentally swallowed get medical help or contact a poison control center right away." ], "spl_product_data_elements": [ "ADVANCED FLUORIDE ANTICAVITY SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION CALCIUM CARBONATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE POWDERED CELLULOSE GLYCERIN ALUMINUM OXIDE HYDRATED SILICA POTASSIUM SORBATE SACCHARIN SODIUM SODIUM LAURYL SULFATE SORBITAN MONOOLEATE SORBITOL TITANIUM DIOXIDE WATER XANTHAN GUM FD&C BLUE NO. 1" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions adults and children 2 years. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist. do not swallow to minimize swallowing, use a pea-sized amount in children under 6 years old supervise children's brushing until good habits are established children under 2y ears: ask a dentist before use." ], "spl_unclassified_section": [ "CAVITY FIGHTING TOOTHPASTE Distributed by: Personal Care Products, LLC Bingham Farms, MI 48025-2463 Made in China" ], "package_label_principal_display_panel": [ "Advanced Fluoride Anticavity Toothpaste New Ultra Breath Freshener Stripe Net Wt 6.4oz (181g) Multi Protection Fights Cavities Freshens Breath", "Advanced Whitening Toothpaste", "Advanced Whitening Toothpaste", "Advanced Whitening Toothpaste" ], "indications_and_usage": [ "Use Aids in the prevention of cavities" ], "set_id": "594d5fbc-a134-45ac-a8a7-d4d49d753ac7", "id": "aa6d87e0-cfa1-4cc0-af22-0036fca25bfd", "active_ingredient": [ "Active Ingredent Sodium Monofluorophosphate 0.76%" ] }, { "effective_time": "20130418", "inactive_ingredient": [ "Inactive Ingredients purified water, glycerin, propylene glycol, sorbitol, polysorbate 80, poloxamer 407, flavor, versene, cetylpyridinium chloride, sodium lauroyl sarcosinate, sodium saccharin, sodium hydroxide, citric acid, natamycin, FD and C green #5, FD and C red #33." ], "purpose": [ "Purpose Anti-cavity" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children." ], "warnings": [ "Warnings Do not swallow. In case of accidental ingestion, seek medical help or contact a poison control center immediately. Cold weather may cloud this product. Properties are not affected." ], "spl_product_data_elements": [ "Oral Defense Fluoride Rinse Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION WATER EDETATE DISODIUM POLOXAMER 407 PROPYLENE GLYCOL CETYLPYRIDINIUM CHLORIDE SORBITOL SACCHARIN SODIUM ANHYDROUS GLYCERIN POLYSORBATE 80 NATAMYCIN MINT SODIUM LAUROYL SARCOSINATE SODIUM HYDROXIDE CITRIC ACID MONOHYDRATE Vanilla Mint Blue green" ], "openfda": {}, "version": "12", "dosage_and_administration": [ "Directions Adults and children 6 years of age and older Use once a day, preferably before bedtime, after brushing and flossing thoroughly. For mature adults with gum recession, it is beneficial to use an interdental proxy brush (toothpick type plastic brush) to remove all food debris between all teeth. Use 10ml (1/3oz) and vigorously swish between the teeth for 1 minute. Spit out. Do not swallow. Supervise children over 6 years of age until capable of suing without supervision. Consult with a dentist or doctor for use with children under 6 years of age. Do not take in food or drink for 30 minutes after application." ], "package_label_principal_display_panel": [ "Labels Oral Defense Fluoride Rinse Label Oral Defense Fluoride 2oz" ], "indications_and_usage": [ "Uses Aids in the prevention of dental cavities" ], "set_id": "59a1f399-3609-4eef-b635-1f526cd75819", "id": "bc01abf8-ac41-40c1-a4ab-1d4ba7c64a42", "active_ingredient": [ "Drug Facts Active Ingredients Sodium Fluoride .05% (0.22% w/v fluoride ion)" ] }, { "spl_product_data_elements": [ "Brotapp Brompheniramine maleate and Pseudoephedrine hydrochloride BROMPHENIRAMINE MALEATE BROMPHENIRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 PROPYLENE GLYCOL SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SORBITOL WATER grape flavor" ], "active_ingredient": [ "Active Ingredient: Brompheniramine maleate 1 mg (in each 5 mL(TSP)) Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL(TSP))" ], "purpose": [ "Purpose of Brompheniramine maleate: Antihistamine Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant" ], "indications_and_usage": [ "Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose" ], "warnings": [ "Warnings Do not use in a child under 6 years of age Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use in a child under 6 years of age Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland breathing problem such as emphysema or chronic bronchitis" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "when_using": [ "When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions Do not take more than 4 doses in any 24-hour period Adults and children 12 years and over 4 teaspoonfuls (TSP) every 6 hours Children 6 to under 12 years 2 teaspoonfuls (TSP) every 6 hours Children under 6 years DO NOT USE Other information Store at room temperature 20°-25°C (68°-77°F)." ], "dosage_and_administration_table": [ "
Adults and children 12 years and over 4 teaspoonfuls (TSP) every 6 hours
Children 6 to under 12 years 2 teaspoonfuls (TSP) every 6 hours
Children under 6 years DO NOT USE
" ], "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C blue no. 1, FD&C red no. 40, grape flavor, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water." ], "questions": [ "Questions 888-974-5279 Manufactured by: Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave Carmel, NY 10512 USA" ], "package_label_principal_display_panel": [ "118 mL Container Label" ], "set_id": "5a6dbbda-a393-4cbe-b876-1314865a913e", "id": "582ad13d-dcc2-427d-aeea-0c66953c6eb6", "effective_time": "20140627", "version": "18", "openfda": {} }, { "effective_time": "20101129", "inactive_ingredient": [ "Inactive ingredients Sorbitol, Sodium Bicarbonate (baking soda), Water, Hydrated Silica, Glycerin, Tetrasodium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Sodium Saccharin, Sodium Lauroyl Sarcosinate, Cellulose Gum, Blue 1, Yellow 5." ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warning Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET or visit www.myoralcare.com" ], "spl_product_data_elements": [ "Advance White Brilliant Sparkle Tartar Control Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL SODIUM BICARBONATE WATER HYDRATED SILICA GLYCERIN SODIUM PYROPHOSPHATE SODIUM LAURYL SULFATE SACCHARIN SODIUM DIHYDRATE SODIUM LAUROYL SARCOSINATE CARBOXYMETHYLCELLULOSE SODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision adults and children 2 years and older brush teeth throughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years consult a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel ARM AND HAMMER The Standard of Purity Fluoride Anti-Cavity Toothpaste ADVANCE WHITE Brilliant Sparkle Gel Tartar Control NET WT. 4.3 OZ. (121g) FRESH FROM THE DENTIST FEELING OF CLEAN Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "5b31cca9-cd62-4d0b-babb-8c115e954f86", "id": "3a554c53-6b2a-4a1e-a3c1-c738afb6a4a7", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20120213", "inactive_ingredient": [ "Inactive ingredients alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Cough suppressant Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product constipation may occur or be aggravated" ], "spl_product_data_elements": [ "Guaifenesin and Codeine Phosphate SF guaifenesin and codeine phosphate CODEINE PHOSPHATE CODEINE GUAIFENESIN GUAIFENESIN ALCOHOL CARAMEL CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN MENTHOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with excessive phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take every 4 hours do not take more than 6 doses in any 24-hour period adults and children 12 years and over take 10 mL (2 tsp) children 6 years to under 12 years take 5 mL (1 tsp) children 2 years to under 6 years consult a doctor children under 2 years do not use Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "spl_unclassified_section": [ "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev. 11/09 R6 8081202 1075 Additional barcode labeling applied by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146" ], "storage_and_handling": [ "Other information store at 15° to 30°C (59° to 86°F) You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811 ." ], "do_not_use": [ "Do not use in a child under 2 years of age if you or your child has a chronic pulmonary disease or shortness of breath if your child is taking other drugs, unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Guaifenesin and Codeine Phosphate Syrup SF 100/10 mg (118 mL) NDC 54868-4768-0 image of package label" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive calms the cough control center and relieves coughing" ], "set_id": "5b426e6a-b892-4ed9-afee-06d5a8af6320", "id": "41cac0ee-a39b-4f65-b3b2-fb48d7dbf777", "active_ingredient": [ "Active ingredients (in each 5 mL = 1 tsp) Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 10 mL (2 tsp)
children 6 years to under 12 years take 5 mL (1 tsp)
children 2 years to under 6 years consult a doctor
children under 2 years do not use
" ] }, { "effective_time": "20110106", "purpose": [ "Purpose Brompheniramine Maleate Antihistamine Dextromethorphan HBr Antitussive Phenylephrine HCl Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately." ], "when_using": [ "When using this product ∙ drowsiness may occur ∙ avoid alcoholic beverages ∙ alcohol, sedatives, and tranquilizers may increase drowsiness ∙ be careful when driving a motor vehicle or operating machinery ∙ excitability may occur, especially in children" ], "questions": [ "Questions or Comments? Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com ." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ∙ ask a health professional before use." ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever (allergic rhinitis): ∙ cough due to minor throat and bronchial irritation ∙ runny nose ∙ sneezing ∙ itchy, watery eyes ∙ itching of the nose or throat ∙ Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis. ∙ Temporarily restores freer breathing through the nose" ], "set_id": "5b72a0cc-6762-4218-a898-7e3cda195c05", "id": "65193874-bb1f-4ace-bcf0-7c82738f5b17", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are ∙ taking any other nasal decongestant or stimulant ∙ taking sedatives or tranquilizers" ], "active_ingredient": [ "Active Ingredients In each 5 mL (1 teaspoonful) red, strawberry flavored liquid Brompheniramine Maleate, USP 4 mg Dextromethorphan HBr, USP 15 mg Phenylephrine HCl, USP 7.5 mg" ], "dosage_and_administration_table": [ "
Age Dose
Adults and children over 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours
Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 to 6 hours
Children under 6 years of age Ask your doctor
" ], "inactive_ingredient": [ "Inactive Ingredients Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring" ], "warnings": [ "Warnings Do not exceed recommended dosage." ], "spl_product_data_elements": [ "Y-Cof DMX Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride BROMPHENIRAMINE MALEATE BROMPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZOIC ACID EDETATE DISODIUM FD&C RED NO. 40 PROPYLENE GLYCOL WATER SACCHARIN SODIUM SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if you have ∙ heart disease ∙ high blood pressure ∙ thyroid disease ∙ diabetes ∙ glaucoma ∙ trouble urinating due to an enlarged prostate gland ∙ a breathing problem such as emphysema or chronic bronchitis ∙ a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema ∙ a cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Do not exceed 6 doses in a 24-hour period Age Dose Adults and children over 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 to 6 hours Children under 6 years of age Ask your doctor Other Information store at 20°-25°C (68°-77°F)" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if ∙ nervousness, dizziness, or sleeplessness occur ∙ cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use ∙ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug." ], "package_label_principal_display_panel": [ "Principal Display Panel Figure 1: 16 oz Bottle Label 65193874-figure-01" ] }, { "effective_time": "20131001", "inactive_ingredient": [ "Inactive Ingredients Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Phosphate, Sodium Saccharin, Sodium Hydroxide, CI 45430 (FD&C Red No. 3)." ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children Keep out of reach of children under 6 years of age." ], "warnings": [ "Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions Questions? 1-800-433-6835" ], "spl_product_data_elements": [ "DenTek Kids Anticavity Fluoride Looney Tunes Bubblegum Blast sodium fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM PHOSPHATE SACCHARIN SODIUM DIHYDRATE SODIUM HYDROXIDE CI 45430 (FD&C Red No. 3) Proprietary blend" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions .Adults and children 2 years of age and older: brush teeth thoroughly after meals or at least twice a day or use as directed by dentist .Children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) .Children under 2 years: ask a dentist or physician" ], "package_label_principal_display_panel": [ "toothpaste tube label label for outside of tube" ], "indications_and_usage": [ "Indications and Use Use: Helps protect against cavities" ], "set_id": "5cab16d1-7d22-4d66-b31f-0d62beecb059", "id": "a98b3928-13a9-41d6-9fc0-d3a70824c69f", "active_ingredient": [ "Active Ingredients Sodium Fluoride 0.22% (0.126% w/v Fluoride Ion)" ] }, { "effective_time": "20140303", "inactive_ingredient": [ "Inactive Ingredients Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharin sodium, Tocopheryl acetate, Xylitol" ], "purpose": [ "Purpose Oral Anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other \"-caine\" anesthetics. Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly. Do not exceed recommended dosage." ], "spl_product_data_elements": [ "Mark 3 Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM .ALPHA.-TOCOPHEROL ACETATE XYLITOL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of the product. Children under 2 years of age: Consult a dentist or doctor." ], "spl_unclassified_section": [ "Other Information Store at room temperature 59 - 86°F (15 - 30°C). Protect from freezing and heat.", "Distributed by Mark 3, 135 North Rt. 9W, Congers, NY, 10920 1-888-732-2913" ], "do_not_use": [ "Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.", "Do not exceed recommended dosage." ], "package_label_principal_display_panel": [ "Mark 3 Oral Anesthetic Gel Strawberry Dye Free Gluten Free with Vitamin E and Xylitol NDC 61509-109-32 Net Wt. 1.12 oz. (32 g) Distributed by Mark 3, 135 North Rt. 9W, Congers, NY 10920 Made in USA 20140303 Strawberry Dye Free" ], "indications_and_usage": [ "Uses For the temporary relief of pain associated with canker sores and minor dental procedures." ], "set_id": "5dd04527-9f5f-454d-a95c-659c159c087c", "id": "52a942d1-9198-44c2-aae9-e79af55857ff", "active_ingredient": [ "Active Ingredient Benzocaine, 20%" ] }, { "effective_time": "20121105", "inactive_ingredient": [ "Inactive ingredients cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum" ], "purpose": [ "Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact aids in the prevention of dental cavities" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Live Better Extra Whitening Fluoride SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION WATER SACCHARIN SODIUM SODIUM TRIPOLYPHOSPHATE POLYETHYLENE GLYCOL 400 SORBITOL TITANIUM DIOXIDE SODIUM HYDROXIDE GLYCERIN XANTHAN GUM HYDRATED SILICA COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE mint" ], "other_safety_information": [ "Other Information Store in a cool dry place. Keep tube capped when not in use." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor." ], "package_label_principal_display_panel": [ "mm1.jpg mm2.jpg Carton label Tube Label" ], "indications_and_usage": [ "Directions Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth." ], "set_id": "5e2ef21e-ac8c-41a2-9707-2f717af1f1ec", "id": "e16ccad5-f10f-4a0b-884f-84bf6597d715", "active_ingredient": [ "Active ingredients / Purpose Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity" ] }, { "effective_time": "20101203", "inactive_ingredient": [ "Inactive ingredients sodium bicarbonate (baking soda), PEG/PPG-38/8 copolymer, PEG/PPG-116/66 copolymer, calcium sulfate, silica, sodium lauryl sulfate, flavor, PEG-8, dipotassium phosphate, sodium saccharin,sodium carbonate peroxide." ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warning Do not use if irritation occur s and persists. _________________________________________________ Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET or visit www.myoralcare.com" ], "spl_product_data_elements": [ "Complete Care Enamel Strengthening Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE POLYETHYLENE GLYCOLS POLOXALENE CALCIUM SULFATE SODIUM LAURYL SULFATE POLYETHYLENE GLYCOL 400 PHOSPHATE ION SACCHARIN SODIUM DIHYDRATE SODIUM CARBONATE Fresh Mint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision rinse away toothpaste residue thoroughly after brushing adults and children 2 years and older brush teeth throughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years consult a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel ARM AND HAMMER The Standard of Purity Fluoride Anti-Cavity Toothpaste PROTECTS and REBUILDS ENAMEL COMPLETE CARE Enamel Strengthening FRESH MINT NET WT. 6.0 OZ. (170g) Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "5ebaf670-ebb7-418a-b163-c9f1627864cf", "id": "71fb849f-f7f8-470e-9fd7-db1366056bae", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] } ] }