{ "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": "2026-08-14", "results": { "skip": 0, "limit": 100, "total": 143 } }, "results": [ { "effective_time": "20121109", "purpose": [ "PURPOSES Pain reliever/Fever reducer Antihistamine 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 right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not use more than directed 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 OR COMMENTS? Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "OTHER INFORMATION each teaspoon contains: sodium 2 mg store at 20 -25°C (68 -77°F) dosage cup provided" ], "indications_and_usage": [ "USES temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies: headache nasal congestion sore throat fever cough minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "0374b3cf-2742-c082-6eb2-3333531e940c", "id": "4f681cb1-403b-45e1-9361-1f7f23951653", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if user is taking any other pain reliever/fever reducer taking sedatives or tranquilizers" ], "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH 5 ML TSP) Acetaminophen, USP 160 mg Chlorpheniramine maleate, USP 1 mg Dextromethorphan HBr, USP 5 mg Phenylephrine HCl, USP 2.5 mg" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over 4 teaspoons every 4 hours
children under 12 years do not use
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous citric acid, artificial & natural flavors, FD&C red no. 40, glycerin, lactic acid, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "warnings": [ "WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if user takes more than 5 doses in 24 hours 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. Do not use to sedate a child or to make a child sleepy if user is 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. with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. Ask a doctor before use if user has liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland 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 Ask a doctor or pharmacist before use if user is taking any other pain reliever/fever reducer taking sedatives or tranquilizers When using this product do not use more than directed 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 user gets nervous, dizzy, or sleepless pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. new symptoms occur 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. Prompt 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": [ "ROBITUSSIN NIGHT TIME COUGH, COLD AND FLU acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Red liquid" ], "ask_doctor": [ "Ask a doctor before use if user has liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland 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" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "DIRECTIONS do not take more than 5 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 4 teaspoons every 4 hours children under 12 years do not use" ], "spl_unclassified_section": [ "DRUG FACTS" ], "stop_use": [ "Stop use and ask a doctor if user gets nervous, dizzy, or sleepless pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. new symptoms occur" ], "do_not_use": [ "Do not use to sedate a child or to make a child sleepy if user is 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. with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure." ], "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 Night Time Cough, Cold, and Flu Acetaminophen >> Pain reliever/Fever reducer Chlorpheniramine maleate >> Antihistamine Dextromethorphan HBr >> Cough suppressant Phenylephrine HCl >> Nasal decongestant RELIEVES: Cough Body Aches/Fever Headache Sore Throat Stuffy Nose Runny Nose Sneezing 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 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 Night Time Cough, Cold & Flu Packaging" ] }, { "effective_time": "20110826", "inactive_ingredient": [ "Inactive Ingredients anhydrous citric acid, D&C res #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose" ], "purpose": [ "Purpose 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 (1-800-222-1222)." ], "warnings": [ "Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in 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)." ], "when_using": [ "When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children" ], "questions": [ "Questions? Adverse drug event call (888) 933-3222" ], "spl_product_data_elements": [ "Select Health Allergy Relief Cherry Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Citric Acid Monohydrate Sodium Benzoate Glycerin polyethylene glycols sodium citrate sodium chloride" ], "ask_doctor": [ "Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. take every 4 to 6 hours do not take more than 6 doses in 24 hours children under 2 years: do not use children 2 to 5 years: do not use unless directed by a doctor children 6 to 12 years: 5 to 10 mL (1 to 2 tsp)" ], "spl_unclassified_section": [ "Drug Facts" ], "storage_and_handling": [ "Other Information each teaspoon contains: sodium 14 mg store between 20 to 25°C (68 to 77°F) protect from light store in outer carton until contents sused." ], "do_not_use": [ "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 ML Bottle Carton Children's ALLERGY RELIEF Health Select ® Diphenhydramine HCl Antihistamine For Temporary Relief of: Itchy, Watery Eyes Itchy Throat Runny Nose Sneezing For Ages 12 and Older Alcohol Free NET 4 FL OZ (118 ML) NDC 49743-3001-1 Principal Display Panel" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "04e38dab-16b1-4848-9dcb-92e9f67e6119", "id": "dfcebe7c-7215-47cf-9e2c-9822439eb207", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each 5 mL tsp) Diphenhydramine HCl 12.5 mg" ] }, { "effective_time": "20130110", "purpose": [ "Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Dextromethorphan HBr 5 mg Cough suppressant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted \"Safety Seal®\" is broken or missing see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever" ], "set_id": "050f7ef8-60fc-4e8f-ae9c-3a7c5682f96f", "id": "82781d0a-7f2e-45c7-9c18-2c688b587f14", "active_ingredient": [ "Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Dextromethorphan HBr 5 mg Cough suppressant" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tsp or mL)
under 36 under 4 years do not use
36-47 4 to 5 years 1 tsp or 5 mL
48-95 6 to 11 years 2 tsp or 10 mL
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, xanthan gum" ], "warnings": [ "Warnings 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 product containing acetaminophen in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has a persistent or chronic cough such as occurs with asthma a cough that occurs with too much phlegm (mucus) When using this product do not exceed recommended dose (see overdose warning ) Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "CHILDRENS TYLENOL PLUS COUGH and SORE THROAT Acetaminophen and Dextromethorphan Hydrobromide Acetaminophen acetaminophen Dextromethorphan Hydrobromide dextromethorphan acesulfame potassium anhydrous citric acid D&C Red no. 33 FD&C Red no. 40 glycerin high fructose corn syrup cellulose, microcrystalline carboxymethylcellulose sodium water sodium benzoate sorbitol xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if the child has a persistent or chronic cough such as occurs with asthma a cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not give more than directed (see overdose warning ) shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tsp or mL) under 36 under 4 years do not use 36-47 4 to 5 years 1 tsp or 5 mL 48-95 6 to 11 years 2 tsp or 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 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 product containing acetaminophen in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product." ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL = 1 teaspoon) Purpose
Acetaminophen 160 mg Pain reliever/fever reducer
Dextromethorphan HBr 5 mg Cough suppressant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL See New Directions NDC 50580-247-04 Children's TYLENOL ® Fever Reducer, Pain Reliever, Cough Suppressant Plus COUGH & SORE THROAT CONTAINS 2 INGREDIENTS: • Fever & Sore Throat Acetaminophen • Cough Dextromethorphan HBr CHERRY FLAVOR 4 FL OZ (120mL) ORAL SUSPENSION Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each 5 mL = 1 teaspoon) Purpose
Acetaminophen 160 mg Pain reliever/fever reducer
Dextromethorphan HBr 5 mg Cough suppressant
" ] }, { "effective_time": "20150116", "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" ], "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 23 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": "0d1771df-d51c-4da6-b8ca-f8aacce5b9df", "id": "0d1771df-d51c-4da6-b8ca-f8aacce5b9df", "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 dose cup 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 anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum." ], "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 two 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." ], "spl_product_data_elements": [ "up and up nighttime sleep-aid DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POTASSIUM CITRATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM" ], "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", "" ], "stop_use": [ "Stop use and ask a doctor if sleeplessness persists continuously for more than two 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 NDC 11673-730-92 Compare to active ingredient in ZzzQuil™* nighttime sleep-aid diphenhydramine HCl non-habit forming alcohol free BERRY FLAVOR SEE WARNINGS NOT FOR TREATING COLD OR FLU 12 FL OZ (354 mL) Failure to follow these warnings could result in serious consequences. TAMPER EVIDENT: Do not use if printed shrink band is missing or broken *This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil® Questions? Call 1-800-910-6874 094 01 0778 R00 ID274446 Distributed by Target Corporation Minneapolis, MN 55403 ©2014 Target Brands, Inc. Shop Target.com up and up nighttime sleep aid Berry Flavor" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-888-287-1915" ], "spl_product_data_elements": [ "equate acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel SEE NEW WARNINGS INFORMATION Compare to Concentrated Tylenol® Infants’ Drops Active Ingredient Ages 2-3 Infants’ Concentrated Acetaminophen Fever Reducer/Pain Reliever Concentrated Suspension Drops Alcohol Free Aspirin Free Ibuprofen Free Grape Flavor Use only with enclosed dropper 80 mg per 0.8 mL Acetaminophen Carton Image 1 Acetaminophen Carton Image 2 Acetaminophen Carton Image 1 Acetaminophen Carton Image 2" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "105c5b97-9386-48a4-ae88-25816e497d84", "id": "e184ce1d-bc6a-48ff-a997-095c258641a5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-774-2678" ], "spl_product_data_elements": [ "Kirkland Signature infants pain relief Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel COMPARE TO CONCENTRATED TYLENOL® INFANTS' DROPS active ingredient INFANTS' Pain Relief Acetaminophen Concentrated Drops Fever Reducer Pain Reliever Aspirin Free Ibuprofen Free Alcohol Free Use only with enclosed dropper See New Warnings Information Ages 2-3 Grape Flavor 80 mg per 0.8 mL Infants' Pain Relief Carton Image 1 Infants' Pain Relief Carton Image 2 Infants' Pain Relief Carton Image 1 Infants' Pain Relief Carton Image 2" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "11af9116-e025-4ff2-8466-0e942b3728c0", "id": "35aa3a2e-d52d-4b94-9202-8360e872ac51", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "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": "20110919", "inactive_ingredient": [ "Inactive ingredients purified water USP, glyceryl stearate, isopropyl palmitate NF, light mineral oil NF, ozokerite, propylene glycol USP, stearyl alcohol NF, PEG-1500 stearate, poloxamer 188, propylene glycol monostearate NF, steareth-20, laureth-23, sodium metabisulfite NF, sodium lauryl sulfate NF, anhydrous citric acid USP, fragrance, methylparaben NF, dimethicone, propylparaben NF, edetate disodium, butylated hydroxyanisole" ], "purpose": [ "Purpose Skin Lightener" ], "keep_out_of_reach_of_children": [ "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. Do not use • On inflamed or broken skin • On children under 12 years of age unless directed by a physician Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away." ], "when_using": [ "When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure" ], "questions": [ "Questions? 1-800-900-6389 (24 hours a day, 7 days a week)" ], "spl_product_data_elements": [ "Esoterica Nighttime with Moisturizers hydroquinone hydroquinone hydroquinone water glyceryl monostearate isopropyl palmitate mineral oil ceresin propylene glycol stearyl alcohol polyethylene glycol 1500 poloxamer 188 steareth-20 laureth-23 sodium metabisulfite sodium lauryl sulfate anhydrous citric acid methylparaben dimethicone propylparaben edetate disodium butylated hydroxyanisole PROPYLENE GLYCOL MONOPALMITOSTEARATE" ], "ask_doctor": [ "Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults • Apply a small amount as a thin layer to affected areas twice daily or as directed by a doctor • For sensitive skin, test overnight on small area (inside elbow) • If no improvement is seen after 3 months of treatment, discontinue use. On very dark skin, lightening effect may not be noticeable • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a healthcare professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: MEDICIS The Dermatology Company ® Scottsdale, AZ 85256" ], "storage_and_handling": [ "Other information • Store at room temperature • Tamper-evident carton • Serious side effects may be reported to the phone number provided in the Questions? section below." ], "do_not_use": [ "Do not use • On inflamed or broken skin • On children under 12 years of age unless directed by a physician" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 70 g Carton Skin Lightener with Moisturizers NDC # 99207-290-02 E ESOTÉRICA ® ESOTÉRICA ® FADE CREAM NIGHTTIME With Moisturizers Net Wt. 2.5 oz (70 g) carton.jpg" ], "indications_and_usage": [ "Use Lightens dark (brownish) areas on the skin such as freckles, age and liver spots, pigment in skin that may occur in pregnancy or from the use of oral contraceptives." ], "set_id": "12adc34c-e65d-4679-b2c3-ab9ff5f615e8", "id": "8f190ff1-ad4c-4e71-9006-38aa705d381b", "active_ingredient": [ "Active ingredients Hydroquinone USP 2%" ] }, { "effective_time": "20151112", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "purpose": [ "Purposes Cough suppressant 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 (1-800-222-1222)." ], "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 • diabetes • high blood pressure • thyroid disease • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland When using this product do not use 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 is accompanied by 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 (1-800-222-1222)." ], "when_using": [ "When using this product do not use more than directed" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Wal Tussin Adult Cough and Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE" ], "ask_doctor": [ "Ask a doctor before use if you have • heart disease • diabetes • high blood pressure • thyroid disease • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland" ], "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 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 • 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 is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition." ], "storage_and_handling": [ "Other information • each 10 mL contains: sodium 5 mg • store at 20-25ºC (68-77ºF). Do not refrigerate." ], "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 ADULT – NON-DROWSY WAL-TUSSIN® CF CF Cough & Cold Dextromethorphan HBr / Cough Suppressant Guaifenesin / Expectorant Phenylephrine HCl / Nasal Decongestant Relieves coughs, stuffy nose & chest congestion / mucus Ages 12 & older Alcohol free 4 FL OZ (118 mL) CHERRY FLAVOR Compare to Robitussin® Multi-Symptom Cold active ingredients Well at Walgreens Wal-Tussin CF image 1 Well at Walgreens Wal-Tussin CF image 2" ], "indications_and_usage": [ "Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation" ], "set_id": "13c6f1e5-1d7e-44dd-9622-124be814b062", "id": "42281a62-7785-4a96-a34a-dc9c826722ff", "active_ingredient": [ "Active ingredients (in each 10 mL) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg Phenylephrine HCl, USP 10 mg" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over 10 mL every 4 hours
children under 12 years do not use
" ] }, { "effective_time": "20131126", "purpose": [ "Active ingredients (in each 15 mL = 1 tablespoon) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage" ], "questions": [ "Questions or comments? call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains: sodium 5 mg store between 20-25°C (68-77°F). Do not refrigerate. do not use if plastic neck wrap or foil inner seal imprinted with \"Safety Seal®\" is broken or missing see back label for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever" ], "set_id": "14727189-8c75-448d-8e3b-944d21df41a7", "id": "dae71f3a-9451-4d82-847a-ff78e21aa991", "active_ingredient": [ "Active ingredients (in each 15 mL = 1 tablespoon) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 tablespoons (tbsp) or 30 mL in dose cup provided every 4 hours do not take more than 12 tablespoons (tbsp) or 180 mL in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose" ], "warnings": [ "Warnings Alcohol warning If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage. 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 product containing acetaminophen 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 trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion 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 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "TYLENOL COLD Cough and Severe Congestion Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin Phenylephrine Hydrochloride Phenylephrine anhydrous citric acid FD&C blue no. 1 FD&C red no. 40 FD&C yellow no. 6 glycerin propylene glycol water sodium benzoate sucralose Amber colored" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 2 tablespoons (tbsp) or 30 mL in dose cup provided every 4 hours do not take more than 12 tablespoons (tbsp) or 180 mL in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion 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 product containing acetaminophen 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 = 1 tablespoon) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-349-08 New! TYLENOL ® Warming HONEY LEMON COUGH & SEVERE CONGESTION Pain Reliever/Fever Reducer , Nasal Decongestant, Cough Suppressant, Expectorant CONTAINS 4 MEDICINES: Fever/Headache/Sore Throat Acetaminophen Nasal Congestion Phenylephrine HCl Coughing Dextromethorphan HBr Chest Congestion Guaifenesin DAYTIME 8 FL OZ (240 mL) Liquid Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each 15 mL = 1 tablespoon) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20101130", "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Diphenhydramine HCl 25 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage 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 or comments? call 1-877-895-3665" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if carton or blister unit is opened or broken see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache sinus congestion and pressure nasal congestion runny nose and sneezing minor aches and pains itching of the nose or throat itchy, watery eyes helps decongest sinus openings and passages" ], "set_id": "150f957a-b7fb-4f89-a421-6f2bc39b6849", "id": "9dfa0205-8228-4bba-905d-3f4662508946", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Diphenhydramine HCl 25 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew or dissolve do not take more than 12 caplets in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, flavors, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, potassium sorbate, propylene glycol, shellac, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide, triacetin" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets 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 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. with any other product containing diphenhydramine, even one used on skin 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage 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 nervousness, dizziness, or sleeplessness occur pain or nasal congestion 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 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. (1-800-222-1222) 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": [ "Tylenol Sinus and Allergy Severe acetaminophen, diphenhydramine Hydrochloride, and phenylephrine Hydrochloride acetaminophen acetaminophen diphenhydramine Hydrochloride diphenhydramine phenylephrine Hydrochloride phenylephrine anhydrous citric acid carnauba wax starch, corn D&C yellow NO. 10 aluminum oxide FD&C yellow NO. 6 hypromelloses ferrosoferric oxide magnesium stearate cellulose, microcrystalline potassium sorbate propylene glycol shellac sodium benzoate sodium citrate sodium starch glycolate type a potato sucralose titanium dioxide triacetin Light yellow TY;S;A;Severe" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion 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 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. with any other product containing diphenhydramine, even one used on skin 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. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-314-24 See New Warnings Information TYLENOL ® SINUS & ALLERGY SEVERE Alleviates Sinus Headache & Pain Acetaminophen Dries Runny Nose Alleviates Itchy, Watery Eyes Diphenhydramine Relieves Sinus Pressure Clears Nasal Congestion Phenylephrine HCl 24 Cool Burst ® CAPLETS PRINCIPAL DISPLAY PANEL" ], "purpose_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20121109", "purpose": [ "PURPOSES Pain reliever/Fever reducer Antihistamine/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 right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not use more than directed 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 OR COMMENTS? Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "USES temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies: headache nasal congestion sore throat fever cough minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "1963424c-7ea9-7a66-ede3-4de1351daa32", "id": "393a8ace-3c2c-4e05-837a-cfd92d4135c4", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin taking any other oral nasal decongestant or stimulant taking any other pain reliever/fever reducer taking sedatives or tranquilizers" ], "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH 5 ML TSP) Acetaminophen, USP 160 mg Diphenhydramine HCl, USP 6.25 mg Phenylephrine HCl, USP 2.5 mg" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over 4 teaspoons every 4 hours
children under 12 years do not use
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "warnings": [ "WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if user takes more than 24 teaspoons in any 24-hour period, 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. Do not use to sedate a child or to 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if user has liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland 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 Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin taking any other oral nasal decongestant or stimulant taking any other pain reliever/fever reducer taking sedatives or tranquilizers When using this product do not use more than directed 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 user gets nervous, dizzy, or sleepless pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. new symptoms occur 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. Prompt 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": [ "ROBITUSSIN NIGHT TIME COUGH, COLD AND FLU acetaminophen, diphenhydramine hcl, phenylephrine hcl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN MENTHOL POLYETHYLENE GLYCOLS PROPYL GALLATE PROPYLENE GLYCOL SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE WATER red" ], "ask_doctor": [ "Ask a doctor before use if user has liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland 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" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than 6 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 4 teaspoons every 4 hours children under 12 years do not use" ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION each teaspoon contains: sodium 4 mg store at 20-25°C (68-77°F)" ], "stop_use": [ "Stop use and ask a doctor if user gets nervous, dizzy, or sleepless pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. new symptoms occur" ], "do_not_use": [ "Do not use to sedate a child or to 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin" ], "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. New formula. See new warnings information. Adult Robitussin Night Time Cough, Cold & Flu Acetaminophen (Pain Reliever/Fever Reducer) Diphenhydramine HCl (Antihistamine/Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) RELIEVES: Cough Body Aches/Fever Headache Sore Throat Stuffy Nose Runny Nose Sneezing For Ages 12 & Over Alcohol-Free 8 FL OZ (237 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 USA © 2010 Wyeth For most recent product information, visit www.robitussin.com Patent Pending Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. PAA016521.jpg" ] }, { "effective_time": "20150605", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, cocoa, maltitol, methylparaben, natural flavor, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate" ], "purpose": [ "Purpose 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 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 heart disease high blood pressure diabetes thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more than directed. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a 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." ], "when_using": [ "When using this product do not use more than directed." ], "questions": [ "Questions or comments? call 1-855-848-3284 toll free" ], "spl_product_data_elements": [ "Dr. Cocoa Daytime Cough and Cold Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ANHYDROUS CITRIC ACID COCOA MALTITOL METHYLPARABEN PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE TRISODIUM CITRATE DIHYDRATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure diabetes thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions shake well before use measure only with dosing spoon provided read dosing spoon carefully. Dosing spoon holds 5 mL when filled to the top rim do not use dosing spoon with other products dose as follows or as directed by a doctor mL = milliliter Dr. Cocoa Daytime Cough+Cold Dosing Chart" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a 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." ], "storage_and_handling": [ "Other information each 5 mL contains: sodium 7 mg 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 - 120 mL Bottle Label NDC 65224-721-04 Dr. Cocoa™ .................... for Children Daytime Cough+Cold Dextromethorphan HBr (Cough Suppressant) Phenylepherine HCl (Nasal Decongestant) For Ages 4+ 120 mL (4 FL OZ) Dr. Cocoa Daytime Cough+Cold Bottle Label", "PRINCIPAL DISPLAY PANEL - 120 mL Carton NDC 65224-721-04 NEW! Dr. Cocoa™ .................... for Children Daytime Cough+Cold Dextromethorphan HBr (Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves: Cough Stuffy Nose For Ages 4+ Real Chocolate Taste 120 mL (4 FL OZ) Dr. Cocoa Daytime Cough+Cold" ], "indications_and_usage": [ "Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold nasal congestion" ], "set_id": "1b1acf71-12cb-44e3-823e-8c18cc3d5712", "id": "76d4a0fa-ba93-4774-8244-127315016e37", "active_ingredient": [ "Drug Facts Active ingredient (in each 5 mL) Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg Purpose Cough suppressant Nasal decongestant" ] }, { "effective_time": "20150803", "inactive_ingredient": [ "Inactive ingredients acrylates copolymer, anhydrous citric acid, astragalus membranaceus root extract, C8-22 alkyl acrylates/methacrylic acid crosspolymer, caprylyl glycol, cocamidopropyl betaine, edetate disodium, forsythia suspensa fruit extract, fragrance, glycerin, methyl gluceth-20, PEG/PPG-8/3 diisostearate, phenoxyethanol, polysorbate 20, potassium sorbate, purified water, sodium benzoate, sodium C14-16 olefin sulfonate, sorbic acid, trolamine" ], "purpose": [ "Purpose Salicylic acid - Acne treatment" ], "keep_out_of_reach_of_children": [ "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 When using this product • avoid contact with eyes. If contact occurs, flush thoroughly with water. • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product • avoid contact with eyes. If contact occurs, flush thoroughly with water. • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor." ], "questions": [ "Questions? Toll free 1-877-636-2677 MON-FRI 9 AM-5 PM (EST)" ], "spl_product_data_elements": [ "OXY Clinical Advanced Face Wash Salicylic acid SALICYLIC ACID SALICYLIC ACID WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • wet face, then gently massage cleanser onto skin • rinse well and pat dry • use twice daily" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel OXY Clinical Advanced Face Wash Acne Treatment 2% Salicylic Acid Clinical results without a prescription The Mentholatum Company Orchard Park, NY 14127 OXY Clinical Advanced Face Wash Acne Treatment Clinical results without a prescription" ], "indications_and_usage": [ "Uses treats and helps prevent acne blemishes" ], "set_id": "1b3302d8-46dd-4a36-9854-843706580318", "id": "3b06ca43-a267-4bfc-a141-7dc1282a88a0", "active_ingredient": [ "Active ingredient Salicylic acid 2%" ] }, { "effective_time": "20120625", "purpose": [ "Active ingredients (in each 20 mL) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed" ], "questions": [ "Questions? 1-866-MUCINEX (1-866-682-4639) 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 20 mL contains: sodium 12 mg tamper evident: do not use if neckband on bottle cap is broken or missing store between 15-30°C (59-86°F) do not refrigerate dosing cup provided" ], "indications_and_usage": [ "Uses temporarily relieves these common cold and flu symptoms: nasal congestion sinus congestion and pressure cough due to minor throat and bronchial irritation minor aches and pains sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive" ], "set_id": "1c540456-8a20-4ba9-a6b2-c0f5fc4ec3b5", "id": "d973ecc7-ae8e-4a39-8110-6a98419f2455", "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 20 mL) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient , xanthan gum" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 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. for children under 12 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. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) 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 nervousness, dizziness or sleeplessness occur pain, nasal congestion 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 and signs or symptoms." ], "spl_product_data_elements": [ "Mucinex Fast-Max Cold, Flu and Sore Throat Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin Phenylephrine Hydrochloride Phenylephrine Anhydrous Citric Acid Edetate Disodium FD&C Blue No. 1 FD&C Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Trisodium Citrate Dihydrate Xanthan Gum" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see Overdose warning ) 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 dose as follows or as directed by a doctor mL = milliliter Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours. Children under 12 years of age: Do not use." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion 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. for children under 12 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." ], "active_ingredient_table": [ "
Active ingredients (in each 20 mL) Purpose
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label MAXIMUM STRENGTH* NDC 63824-015-69 Mucinex ® FAST-MAX™ Cold, Flu & Sore Throat Acetaminophen • Pain Reliever/Fever Reducer Dextromethorphan HBr • Cough Suppressant Guaifenesin • Expectorant Phenylephrine HCl • Nasal Decongestant NEW VALUE SIZE! ✔ Relieves Headache & Fever ✔ Controls Cough ✔ Relieves Nasal & Chest Congestion ✔ Thins & Loosens Mucus 9 fl oz (266 mL) For Ages 12+ Principal Display Panel - 266 mL Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 20 mL) Purpose
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
" ] }, { "effective_time": "20121109", "purpose": [ "PURPOSES Antihistamine 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." ], "when_using": [ "When using this product do not use more than directed 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 OR COMMENTS? Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "USES temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "1c6a66f0-f48a-64eb-6f2d-7e61de2d1255", "id": "f7da8181-b453-4c3b-807b-aae705b9882d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH 5 ML TSP) Chlorpheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 15 mg" ], "dosage_and_administration_table": [ "
age dose
children under 12 years do not use
adults and children 12 years and over 2 teaspoons every 6 hours
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous citric acid, artificial & natural flavors, FD&C red no. 40, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "warnings": [ "WARNINGS Do not use to sedate a child or to 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 trouble urinating due to an enlarged prostate gland glaucoma a 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 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 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 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": [ "ROBITUSSIN COUGH AND COLD LONG ACTING chlorpheniramine maleate, dextromethorphan HBr CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN LACTIC ACID MENTHOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE" ], "ask_doctor": [ "Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a 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" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than 4 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose children under 12 years do not use adults and children 12 years and over 2 teaspoons every 6 hours" ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION store at 20-25°C (68-77°F) 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 to sedate a child or to 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." ], "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 & Cold LONG-ACTING CHLORPHENIRAMINE MALEATE (Antihistamine) DEXTROMETHORPHAN HBr (Cough Suppressant) RELIEVES: Cough: Up to 8 Hours Runny Nose 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 & Cold Long-Acting Packaging" ] }, { "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": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "good neighbor pharmacy pain relief infants Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel See New Warnings Information Compare to Active Ingredient of Concentrated Tylenol® Infants’ Drops Infants’ Pain Relief Concentrated Drops Acetaminophen Fever Reducer Pain Reliever Use only with enclosed dropper Grape Flavor Alcohol-Free Aspirin-Free Ibuprofen-Free 80 mg per 0.8 mL Infants' Pain Relief Carton Infants' Pain Relief Carton" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "1defa32d-33df-468e-b4a3-62050165a4f5", "id": "fce27bc0-974b-42b9-9676-6fcc97698b5f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20120117", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-616-2471" ], "spl_product_data_elements": [ "mapap infants concentrated Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL opaque sweet" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not give more than directed (see Liver warning) shake well before using 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 if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor replace dropper tightly to maintain child resistance this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information store at 20°-25°C (68°-77°F) do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel Mapap 80mg/0.8ml" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache" ], "set_id": "1df75cdf-dc04-41f8-846e-77ce9ab24548", "id": "1df75cdf-dc04-41f8-846e-77ce9ab24548", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20121025", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information each teaspoon contains: sodium 2 mg store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted \"Safety Seal®\" is broken or missing see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache" ], "set_id": "1e0c0d35-c713-4ca5-9c7d-9e89b22516c2", "id": "20edfbfe-365d-4c16-8496-7ac981851ca4", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 5 mL = 1 teaspoon) Acetaminophen 160 mg" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tsp or mL)
under 24 under 2 years ask a doctor
24-35 2-3 years 1 tsp or 5 mL
36-47 4-5 years 1 1/2 tsp or 7.5 mL
48-59 6-8 years 2 tsp or 10 mL
60-71 9-10 years 2 1/2 tsp or 12.5 mL
72-95 11 years 3 tsp or 15 mL
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum" ], "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. 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 this product do not exceed recommended dose (see overdose warning ) 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens TYLENOL Acetaminophen Acetaminophen acetaminophen anhydrous citric acid butylparaben D&C red NO. 33 FD&C red NO. 40 glycerin high fructose corn syrup cellulose, microcrystalline carboxymethylcellulose sodium propylene glycol water sodium benzoate sorbitol sucralose xanthan gum Dark pink" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "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 ) shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2-3 years 1 tsp or 5 mL 36-47 4-5 years 1 1/2 tsp or 7.5 mL 48-59 6-8 years 2 tsp or 10 mL 60-71 9-10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "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." ], "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 See New Warnings Information NDC 50580-407-04 Children's TYLENOL ® Acetaminophen Oral Suspension Fever Reducer, Pain Reliever AGES 2-11 Pediatricians' 1st Choice Alcohol Free Aspirin Free Ibuprofen Free bubblegum YUM FLAVOR 4 FL OZ (120mL) 80 mg per 1/2 teaspoon (160 mg per 5 mL) Principal Display Panel" ] }, { "effective_time": "20151209", "inactive_ingredient": [ "Nighttime Inactive Ingredient Acesulfame potassium, Aspartame, Caramel, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar.", "Multi-Symptom Inactive Ingredient Acesulfame potassium, anhydrous citric acid, Aspartame, calcium phosphate dibasic, caramel, D and C yellow No. 10, flavors, Maltodextrin, Silicon dioxide, Sodium Citrate, Starch and Sucrose." ], "purpose": [ "Purpose Nighttime Uses - temporarily relieves these symptoms due to a cold: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat - temporarily reduces fever.", "Purpose Multi-Symptom Uses - Temporarily relieves these symptoms due to a cold: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Nighttime Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include - skin reddening - blisters - rash. If a skin reaction occurs, stop use and seek medical help right away. 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 - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - with any other product containing diphenhydramine, even one used on the skin - 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 a MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. - 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 exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - 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 occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Multi-Symptom Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include - skin redenning - blisters - rash. If a skin reaction occurs, stop use and seek medical help right away. 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 - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and 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 a MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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": [ "Well at Walgreens Multi-Symptom Wal-Flu Severe Cold and Nighttime Wal-Flu Severe Cold and Cough Kit Acetaminophen, Diphenhydramine HCL, Phenylephrine HCL and Dextromethorphan HBr Walgreens Nighttime Wal-Flu Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon flavor Natural Honey and Lemon flavor Caramel color D and C Yellow 10 Walgreens Multi-Symptom Wal-Flu Severe Cold Green Tea and Honey Lemon Flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon flavor Natural Honey and Lemon Flavor Caramel color D and C Yellow No. 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. - 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 exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - 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 occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Nighttime Dosage and Administration Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and older one packet - do not use more than directed. - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - dissolve content of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.", "Multi-Symptom Dosage & Administration Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet - do not use more than directed. - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "do_not_use": [ "Do not use - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - with any other product containing diphenhydramine, even one used on the skin - 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 a MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. - 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 exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - 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 occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Do not use - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and 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 a MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "information_for_patients": [ "Nighttime Information for Patients Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.", "Multi-Symptom Information for Patients Other information - each packet contains: potassium 8 mg, sodium 15 mg, calcium 120 mg. - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1. jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - 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 occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "set_id": "1f336dce-df94-4c93-b901-17efc0b899d7", "id": "267ace69-bb22-482f-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "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 exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - 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 occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active Ingredients for Nighttime Wal-Flu Severe Cold and Cough Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg...................................Nasal decongestant.", "Active Ingredients for Multi-Symptom Wal-Flu Severe Cold Active ingredients (in each packet) Purpose Acetaminophen 500 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and older one packet
", "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ] }, { "effective_time": "20090803", "spl_unclassified_section_table": [ "
age dose
adults and children 12 years and over 2 teaspoons every 4 hours
children under 12 years do not use
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "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 to sedate a child or to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema 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 drinks be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children 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" ], "when_using": [ "When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "QUESTIONS OR COMMENTS? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675" ], "spl_product_data_elements": [ "ROBITUSSIN NIGHT TIME COUGH AND CHEST CONGESTION diphenhydramine HCl, guaifenesin diphenhydramine hydrochloride diphenhydramine guaifenesin guaifenesin" ], "ask_doctor": [ "Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema" ], "openfda": {}, "version": "1", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "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 teaspoons every 4 hours children under 12 years do not use", "OTHER INFORMATION each teaspoon contains : sodium 3 mg store at 20-25°C (68-77°F) 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 to sedate a child or to make a child sleepy with any other product containing diphenhydramine, even one used on skin" ], "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. Adult Robitussin Night Time Cough and Chest Congestion DIPHENHYDRAMINE HCl (Cough Suppressant) GUAIFENESIN (Expectorant) 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 USA © 2009 Wyeth For most recent product information, visit www.robitussin.com Packaged with Tamper-Evident bottle cap. Do not use if breakable ring is separated or missing. Robitussin Night Time Cough and Chest Congestion 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": "207b5fa1-8c19-9efc-665f-a3f8987d03e7", "id": "207b5fa1-8c19-9efc-665f-a3f8987d03e7", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH 5 ML TSP) Diphenhydramine HCl, USP 12.5 mg Guaifenesin, USP 200 mg" ] }, { "effective_time": "20120420", "purpose": [ "Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted \"Safety Seal®\" is broken or missing see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat cough stuffy nose sneezing and runny nose temporarily reduces fever" ], "set_id": "209a3a62-2c60-49d5-bca1-3281034797f6", "id": "626b377c-0fe0-4f2c-af52-4c087a39b608", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tsp or mL)
under 36 under 4 years do not use
36-47 4 to 5 years do not use unless directed by a doctor
48-95 6 to 11 years 2 tsp or 10 mL
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol solution, sucralose, sucrose, xanthan gum" ], "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. to make a child sleepy in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dose (see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens Tylenol Plus Multi-Symptom Cold acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine anhydrous citric acid butylparaben glycerin cellulose, microcrystalline carboxymethylcellulose sodium propylene glycol propylparaben water sodium citrate sorbitol sucralose sucrose xanthan gum white to off white" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) a breathing problem such as chronic bronchitis glaucoma" ], "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 ) shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tsp or mL) under 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 2 tsp or 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 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. to make a child sleepy in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL = 1 teaspoon) Purpose
Acetaminophen 160 mg Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg Antihistamine
Dextromethorphan HBr 5 mg Cough suppressant
Phenylephrine HCl 2.5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL See New Warnings Information NDC 50580-255-04 Children's TYLENOL ® Plus MULTI-SYMPTOM COLD Dye-Free NON-STAINING FORMULA Fever & Sore Throat Acetaminophen Cough Dextromethorphan HBr Stuffy Nose Phenylephrine HCl Sneezing & Runny Nose Chlorpheniramine Maleate GRAPE FLAVOR 4 FL OZ (120mL) ORAL SUSPENSION Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each 5 mL = 1 teaspoon) Purpose
Acetaminophen 160 mg Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg Antihistamine
Dextromethorphan HBr 5 mg Cough suppressant
Phenylephrine HCl 2.5 mg Nasal decongestant
" ] }, { "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": "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": "20151217", "purpose": [ "Purposes Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product • do not exceed recommended dosage • avoid alcoholic drinks • marked drowsiness may occur • 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? 1-877-932-7948" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information • each packet contains: potassium 10 mg and sodium 25 mg • phenylketonurics: contains phenylalanine 13 mg per packet • store at 20-25°C (68-77°F)" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • runny nose • sneezing • itchy nose or throat • itchy, watery eyes due to hay fever • cough due to minor throat and bronchial irritation • temporarily reduces fever" ], "set_id": "26112a21-f2c3-4021-898b-a86d357a0a91", "id": "773eb167-6652-40fd-a664-9d5de77b233d", "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 packet) Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. 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." ], "spl_product_data_elements": [ "equaline flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME SILICON DIOXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SODIUM CITRATE SUCROSE TRIBASIC CALCIUM PHOSPHATE Light to dark" ], "ask_doctor": [ "Ask a doctor before use if you have • liver disease • 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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions • do not use more than directed (see overdose warning) • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "stop_use": [ "Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain, cough or nasal congestion gets worse or lasts more than 7 days • cough 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 have ever had an allergic reaction to this product or any of its ingredients • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • with any other product containing diphenhydramine, even one used on skin • 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": [ "Package/Label Principal Display Panel compare to Theraflu® Nighttime Severe Cold & Cough active ingredients flu & severe cold & cough nighttime acetaminophen (pain reliever/fever reducer) diphenhydramine HCl (antihistamine/cough suppressant) phenylephrine HCl (nasal decongestant) relieves: nasal congestion cough runny nose sneezing body ache sore throat pain headache/fever SEE NEW WARNINGS honey lemon infused with white tea flavors 6 packets Equaline Flu & Severe Cold & Cough image 1 Equaline Flu & Severe Cold & Cough image 2" ] }, { "effective_time": "20130228", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, aspartame, flavors, sodium bicarbonate, sucralose, yellow no 6." ], "purpose": [ "Purpose Fiber therapy for regularity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a doctor or a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Choking Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Allergy alert This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium. Ask a doctor before use if you have • a sudden change in bowel habits persisting for 2 weeks • abdominal pain, nausea or vomiting Stop use and ask a doctor if • constipation lasts more than 7 days • rectal bleeding occurs These may be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a doctor or a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "CVS Natural Fiber Effervescent Psyllium Husk Psyllium Husk Psyllium Husk aspartame citric acid monohydrate FD&C Yellow No. 6 SODIUM BICARBONATE SUCRALOSE" ], "ask_doctor": [ "Ask a doctor before use if you have • a sudden change in bowel habits persisting for 2 weeks • abdominal pain, nausea or vomiting" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Put one packet into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. Adults 12 yrs. & older: 1 packet in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours. Bulk forming fibers, like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating. New Users Start with 1 dose per day; gradually increase to 3 doses per day as necessary." ], "spl_unclassified_section": [ "Drug Facts", "Distributed By: CVS Pharmacy, Inc. One CVS Drive, Woonsocket RI 02895 CVS.com 1-800-SHOP CVS" ], "stop_use": [ "Stop use and ask a doctor if • constipation lasts more than 7 days • rectal bleeding occurs These may be signs of a serious condition." ], "storage_and_handling": [ "Other information • each packet contains: potassium 30 mg; sodium 194.0 mg • PHENYLKETONURICS: CONTAINS PHENYLALANINE, 29.0 mg per teaspoon • store at room temperature tightly closed to protect from humidity • do not use if printed package is torn or punctured • contains a 100% natural, therapeutic fiber" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Natural Daily Fiber Effervescent Smooth Dissolving 100% Natural Psyllium Husk Fiber Supplement Compare to the active ingredient in Metamucil ® MultiHealth Fiber Sugar Free Therapy for regularity as part of a healthy lifestyle Promotes digestive health Helps lower cholesterol to promote heart health Orange Naturally and Artificially Flavored 30 Packets CVS Daily Fiber Effervescent" ], "indications_and_usage": [ "Uses • for relief of occasional constipation (irregularity)" ], "set_id": "280eafc2-bfdf-4bce-a24c-c55b07ff9d87", "id": "280eafc2-bfdf-4bce-a24c-c55b07ff9d87", "active_ingredient": [ "Active ingredient (in each PACKET) Psyllium husk approximately 3.4 g" ], "dosage_and_administration_table": [ "
Adults 12 yrs. & older: 1 packet in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours.
" ] }, { "effective_time": "20151030", "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose" ], "questions": [ "Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if carton is opened or if blister unit is broken" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache sinus congestion and pressure nasal congestion minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever" ], "set_id": "2baaea43-0b00-4dd7-a46c-7333bfc36af7", "id": "6ed4b89a-cc4b-4879-b6d3-e92a3d30f5c9", "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 caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, carnauba wax, corn starch, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion 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 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 right away. (1-800-222-1222) 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": [ "TYLENOL SINUS CONGESTION AND PAIN DAYTIME Acetaminophen and Phenylephrine hydrochloride Acetaminophen Acetaminophen Phenylephrine hydrochloride Phenylephrine anhydrous citric acid carnauba wax starch, corn D&C yellow no. 10 FD&C blue no. 1 FD&C red no. 40 aluminum oxide hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycols polysorbate 80 potassium sorbate powdered cellulose sodium benzoate sodium citrate sucralose titanium dioxide Sodium Starch Glycolate Type A Potato Light Green TYLENOL;1080" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion 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 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. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-594-24 See New Warnings Information & Directions TYLENOL ® SINUS CONGESTION & PAIN For Adults Acetaminophen, Phenylephrine HCl Pain Reliever/Fever Reducer, Nasal Decongestant DAYTIME Non-Drowsy Sinus Headache Nasal Congestion Sinus Pressure 24 CAPLETS Principal Display Panel - 24 Tablet Carton" ], "purpose_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20130819", "purpose": [ "Purpose 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. (1-800-222-1222)" ], "when_using": [ "When using this product 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 1-800-343-7805" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) do not use if carton is opened, or if bottle wrap printed with \"Safety Seal®\" is broken or missing see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring." ], "set_id": "2cd76d5d-3aa4-4d88-962a-989c0126b798", "id": "9f8f937d-2eff-4a60-9bf8-b1adea711a93", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each 5 mL teaspoonful) Cetirizine HCl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose" ], "warnings": [ "Warnings Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for \"anaphylaxis\" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product 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 an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: 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. (1-800-222-1222)" ], "spl_product_data_elements": [ "Childrens Zyrtec Hives Relief Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine anhydrous citric acid propylene glycol water sodium benzoate sorbitol sucralose" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks" ], "do_not_use": [ "Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-731-05 Children's ZYRTEC ® HIVES Relief Cetirizine HCl 1 mg /mL oral solution antihistamine 24 hour Relief of ITCHING Due to Hives 6 yrs. & older Grape Syrup Dye-Free • Sugar-Free 4 FL OZ (118 mL) Dosing Cup Included PRINCIPAL DISPLAY PANEL" ] }, { "effective_time": "20140418", "purpose": [ "Purpose Fever reducer/pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if carton tape imprinted \"Safety Seal®\" or bottle wrap imprinted \"Safety Seal®\" and \"Use with Enclosed Dosing Device\" is broken or missing see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache" ], "set_id": "2e2e130d-bd70-4ff6-8d9b-571824c65ca8", "id": "ef6f1285-7abe-4ae3-9970-a5f62b079924", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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 anhydrous citric acid, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, xanthan gum" ], "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. 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 this product do not exceed recommended dose (see overdose warning ) 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Concentrated Tylenol Infants Acetaminophen Acetaminophen acetaminophen anhydrous citric acid D&C red no. 33 FD&C blue no. 1 glycerin high fructose corn syrup cellulose, microcrystalline carboxymethylcellulose sodium water sodium benzoate sorbitol xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "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 ) shake well before using 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 if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor replace dropper tightly to maintain child resistance Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "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." ], "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 See New Warnings Information NDC 50580-144-40 Concentrated TYLENOL ® Infants' Drops Acetaminophen Fever Reducer, Pain Reliever INFANTS Pediatricians' 1st Choice Alcohol Free Aspirin Free Ibuprofen Free Grape FLAVOR 1/4 FL OZ (7.5 mL) 80 mg per 0.8 mL USE ONLY Enclosed Dropper Principal Display Panel" ] }, { "effective_time": "20090630", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "purpose": [ "Purpose Cough suppressant 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. (1-800-222-1222)" ], "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 high blood pressure thyroid disease diabetes trouble urinating due to an 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 When using this product do not use 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 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. (1-800-222-1222)" ], "when_using": [ "When using this product do not use more than directed" ], "questions": [ "Questions or comments? 1-800-719-9260 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, OK 74146" ], "spl_product_data_elements": [ "Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an 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" ], "openfda": {}, "version": "1", "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 mL = milliliter; tsp = teaspoonful age dose adults and children 12 years and over 10 mL (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 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 is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each teaspoon contains: sodium 3 mg store at 20º-25ºC (68º-77ºF)" ], "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 Non-Drowsy Tussin CF Cough & Cold Cough Suppressant (Dextromethorphan HBr) Expectorant (Guaifenesin) Nasal Decongestant (Phenylephrine HCl) Relieves: Coughs /Stuffy Nose /Chest Congestion Mucus Adult For Ages 12 & Over Alcohol Free Compare to active ingredients of Robitussin® Cough & Cold CF NDC 54868-6223-1 237 mL image of package label" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation" ], "set_id": "34759c0f-8885-4ecd-9379-0cd88bf152a8", "id": "22703ed4-6d7f-4caa-9bac-399719e8e447", "active_ingredient": [ "Active ingredient (in each 5 mL tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 mg" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over 10 mL (2 tsp) every 4 hours
children under 12 years do not use
" ] }, { "effective_time": "20110919", "inactive_ingredient": [ "Inactive ingredients purified water USP, isopropyl myristate NF, stearyl alcohol NF, glyceryl stearate and sodium lauryl sulfate NF, propylene glycol USP, ozokerite, poloxamer 188, steareth-20, ceteareth-3, fragrance, dimethicone, sodium metabisulfite NF, methylparaben NF, propylparaben NF, sodium lauryl sulfate NF, butylated hydroxyanisole NF, anhydrous citric acid USP, edetate disodium" ], "purpose": [ "Active ingredients: Purpose: Hydroquinone USP 2% Skin Lightener Oxybenzone USP 2.5% Sunscreen Padimate O USP 3.3% Sunscreen" ], "keep_out_of_reach_of_children": [ "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. Do not use • On inflamed or broken skin • For prevention of sunburn • As sunscreen • On children under 12 years of age unless directed by a physician Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away." ], "when_using": [ "When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure" ], "questions": [ "Questions? 1-800-900-6389 (24 hours a day, 7 days a week)" ], "spl_product_data_elements": [ "Esoterica Daytime with Moisturizers and Sunscreen hydroquinone, oxybenzone, and padimate o hydroquinone hydroquinone oxybenzone oxybenzone padimate o padimate o water isopropyl myristate stearyl alcohol glyceryl monostearate sodium lauryl sulfate propylene glycol ceresin poloxamer 188 steareth-20 dimethicone sodium metabisulfite methylparaben propylparaben butylated hydroxyanisole anhydrous citric acid edetate disodium" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults • Apply a small amount as a thin layer to affected areas twice daily or as directed by a doctor • For sensitive skin, test overnight on small area (inside elbow) • If no improvement is seen after 3 months of treatment, discontinue use. On very dark skin, lightening effect may not be noticeable • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a healthcare professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information • Store at room temperature • Tamper-evident carton • Serious side effects may be reported to the phone number provided in the Questions? section below.", "Distributed by: MEDICIS The Dermatology Company ® Scottsdale, AZ 85256" ], "do_not_use": [ "Do not use • On inflamed or broken skin • For prevention of sunburn • As sunscreen • On children under 12 years of age unless directed by a physician" ], "active_ingredient_table": [ "
Active ingredients: Purpose:
Hydroquinone USP 2% Skin Lightener
Oxybenzone USP 2.5% Sunscreen
Padimate O USP 3.3% Sunscreen
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 70 g Jar Carton Skin Lightener with Moisturizers and Sunscreen NDC # 99207-291-02 E ESOTÉRICA ® ESOTÉRICA ® FADE CREAM DAYTIME With Moisturizers and Sunscreen Net Wt. 2.5 oz (70 g) carton.jpg" ], "indications_and_usage": [ "Use Lightens dark (brownish) areas on the skin such as freckles, age and liver spots, pigment in skin that may occur in pregnancy or from the use of oral contraceptives. Contains a sunscreen to help prevent darkening from reoccurring." ], "set_id": "38edad42-4c0d-43eb-b541-a10009e6cf55", "id": "e67fac0a-52f2-4403-914d-53ea6f02e155", "purpose_table": [ "
Active ingredients: Purpose:
Hydroquinone USP 2% Skin Lightener
Oxybenzone USP 2.5% Sunscreen
Padimate O USP 3.3% Sunscreen
" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid" ], "active_ingredient": [ "Active ingredients: Purpose: Hydroquinone USP 2% Skin Lightener Oxybenzone USP 2.5% Sunscreen Padimate O USP 3.3% Sunscreen" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-888-SAFEWAY" ], "spl_product_data_elements": [ "concentrated aspirin free infants Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel Compare to Concentrated Tylenol® Infants’ Drops active ingredient Infants’ Drops For Ages 2 to 3 Concentrated Aspirin Free Suspension Drops Acetaminophen Fever Reducer Pain Reliever Alcohol Free Use only with enclosed dropper Grape Flavor See New Warnings Information 80 mg per 0.8 mL Suspension Drops Carton Suspension Drops Carton" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "3ce3b182-f500-4bb5-9f32-8173c30a4126", "id": "31e348ff-86fb-4053-ac9d-d5875339c06e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "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": "20140528", "purpose": [ "Purpose Antihistamine" ], "precautions": [ "Choking Hazard: Small parts. Keep out of reach of children." ], "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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-855-251-0106" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information Each pre-fille whistle contains 14 mg of sodium Protect from light. SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged. Whistle is not child resistant. Do not remove whistle from child resistant foil pouch prior to use. Store between 68 degrees-77 degrees F (20 degrees - 25 degrees C) Store in outer carton until contents are used." ], "indications_and_usage": [ "Uses For the temporary relief of these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes" ], "set_id": "421359c4-7d79-4000-b25c-509021b69ae2", "id": "39c1b305-bbea-40d8-b1a8-59d04f7c3e5a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (per 5 ml = one pre-filled whistle)* Diphenhydramine HCl 12.5 mg" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and over Take 2-4 pre-filled whistles every 4 to 6 hours, not to exceed 24 whistles in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age Take 1-2 pre-filled whistles every 4 to 6 hours, not to exceed 12 whistles in 24 hours, or as directed by a doctor
Children under 6 years of age Consult a doctor
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, DandC red no. 33, FDandC red no.40, flavor, glycerin, monoammonium glycyrrhizinate, poloxamer 407, sodium benzoate, sodium chloride, sodium citrate, sucrose, water" ], "warnings": [ "Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma difficulty in urination due to enlargement of the prostate gland a sodium-restricted diet a 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 marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children Choking Hazard: Small parts. Keep out of reach of children. 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. Prompt 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": [ "NARAMIN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN AMMONIUM GLYCYRRHIZATE POLOXAMER 407 SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SUCROSE WATER" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma difficulty in urination due to enlargement of the prostate gland a sodium-restricted diet a breathing problem such as emphysema or chronic bronchitis" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years of age and over Take 2-4 pre-filled whistles every 4 to 6 hours, not to exceed 24 whistles in 24 hours, or as directed by a doctor Children 6 to under 12 years of age Take 1-2 pre-filled whistles every 4 to 6 hours, not to exceed 12 whistles in 24 hours, or as directed by a doctor Children under 6 years of age Consult a doctor" ], "spl_unclassified_section": [ "NARAMIN Antihistamine Oral Solution" ], "do_not_use": [ "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "NARAMIN Antihistamine Oral Solution 10-5ml whistles (58292-010-05) Outer Label Inner Label" ] }, { "effective_time": "20150303", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, cocoa, maltitol, methylparaben, natural flavor, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate" ], "purpose": [ "Purpose Antihistamine/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 right away." ], "warnings": [ "Warnings Do not use to make a child sleepy with any other drug containing diphenhydramine, even one used on the skin 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 high blood pressure thyroid disease glaucoma trouble urinating due to an enlarged prostate gland breathing problems 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) Ask a doctor or pharmacist before use if 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 nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a 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." ], "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 or comments? call 1-855-848-3284 toll free" ], "spl_product_data_elements": [ "Dr. Cocoa Nighttime Cough and Cold Diphenhydramine Hydrchloride, Phenylephrine Hydrochloride ANHYDROUS CITRIC ACID COCOA MALTITOL METHYLPARABEN PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE TRISODIUM CITRATE DIHYDRATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease diabetes high blood pressure thyroid disease glaucoma trouble urinating due to an enlarged prostate gland breathing problems 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) Ask a doctor or pharmacist before use if taking sedatives or tranquilizers" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions shake well before use measure only with dosing spoon provided read dosing spoon carefully. Dosing spoon holds 5 mL when filled to the top rim do not use dosing spoon with other products dose as follows or as directed by a doctor mL = milliliter Dr. Cocoa Nighttime Cough+Cold Dosing Chart" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a 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." ], "storage_and_handling": [ "Other information each 5 mL contains: sodium 7 mg store at 20 - 25°C (68 -77°F)" ], "do_not_use": [ "Do not use to make a child sleepy with any other drug containing diphenhydramine, even one used on the skin 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 - 120 mL Bottle Label NDC 65224-743-04 Dr. Cocoa™ .................... for Children Nighttime Cough+Cold Diphenhydramine HCl (Antihistamine/Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) For Ages 6+ 120 mL (4 FL OZ) Dr. Cocoa Nighttime Cough+Cold Label", "PRINCIPAL DISPLAY PANEL - 120 mL Carton NDC 65224-743-04 NEW! Dr. Cocoa™ .................... for Children Nighttime Cough+Cold Diphenhydramine HCl (Antihistamine/Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves: Cough Stuffy Nose Runny Nose Sneezing For Ages 6+ Real Chocolate Taste 120 mL (4 FL OZ) Dr. Cocoa Nighttime Cough+Cold Carton" ], "indications_and_usage": [ "Uses temporarily relieves: sneezing runny nose itchy nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation as may occur with a cold nasal congestion" ], "set_id": "4347ad10-5340-4f69-8166-1492ec588fcc", "id": "10649933-1531-4f38-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if taking sedatives or tranquilizers" ], "active_ingredient": [ "Drug Facts Active ingredients (in each 5 mL) Diphenhydramine HCl 6.25 mg Phenylephrine HCl 2.5 mg Purpose Antihistamine/Cough suppressant Nasal decongestant" ] }, { "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": "20131112", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "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. 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 has ever had an allergic reaction to this product or any of its ingredients 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 this product do not exceed recommended dose (see overdose warning) 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. 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." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning)" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "good sense pain reliefchildrens childrens Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL CALCIUM SULFATE SODIUM PHOSPHATE, TRIBASIC viscous" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "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) •shake well before using •mL = milliliter; tsp = teaspoonful •find right dose on chart. If possible, use weight to dose; otherwise, use age. •remove the children protective cap and squeeze your child’s dose into the dosing cup •repeat dose every 4 hours while symptoms last •do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL (1 tsp) 36-47 4-5 years 7.5 mL ( 1 ½ tsp) 48-59 6-8 years 10 mL (2 tsp) 60-71 9-10 years 12.5 mL (2 ½ tsp) 72-95 11 years 15 mL (3 tsp) *or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with 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." ], "storage_and_handling": [ "Other information •each 5 mL (1 tsp) contains: sodium 3 mg •store at 20-25°C (68-77°F) •do not use if printed neckband is broken or missing" ], "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 has ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "Principal Display Panel For Ages 2 – 11 Children’s Pain Relief Acetaminophen Oral Suspension Fever Reducer/Pain Reliever Suspension Liquid Alcohol Free Aspirin Free Ibuprofen Free Grape Flavor Compare to active ingredient of Children’s Tylenol® Oral Suspension 160 mg per 5 mL Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 IMAGE LABEL" ], "indications_and_usage": [ "Uses temporarily: •reduces fever •relieves minor aches and pains due to: •the common cold •flu •headache •sore throat •toothache" ], "set_id": "45ddd71d-de6c-4e21-a22a-0b37afcc429b", "id": "2af6c8f6-8041-421c-943a-7ee745600a9a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 5 mL = 1 teaspoon) Acetaminophen 160 mg" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (mL or tsp)*
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL (1 tsp)
36-47 4-5 years 7.5 mL ( 1 ½ tsp)
48-59 6-8 years 10 mL (2 tsp)
60-71 9-10 years 12.5 mL (2 ½ tsp)
72-95 11 years 15 mL (3 tsp)
" ] }, { "effective_time": "20131205", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F). Avoid high humidity. do not use if carton is opened, or if neck wrap or foil inner seal imprinted with \"SAFETY SEAL®\" is broken or missing see side panel for lot number and expiration date" ], "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": "46a7a91b-fb37-4a74-b78d-fa7d97c74d04", "id": "fec30cd0-923a-45ba-a2b5-9088c9f923a5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tablets)or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 2-3 years 2 tablets
36-47 4-5 years 3 tablets
48-59 6-8 years 4 tablets
60-71 9-10 years 5 tablets
72-95 11 years 6 tablets
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, flavor, magnesium stearate, povidone, sucralose" ], "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. 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 this product do not exceed recommended dose (see overdose warning ) 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens TYLENOL Acetaminophen Acetaminophen Acetaminophen anhydrous citric acid cellulose acetate crospovidone D&C red no. 7 magnesium stearate povidones sucralose TY;80" ], "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. do not give more than directed (see overdose warning ) find right dose on chart below. If possible, use weight to dose; otherwise, use age. chew before swallowing; this product will soften in mouth for ease of chewing repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 2 tablets 36-47 4-5 years 3 tablets 48-59 6-8 years 4 tablets 60-71 9-10 years 5 tablets 72-95 11 years 6 tablets" ], "spl_unclassified_section": [ "Drug Facts" ], "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." ], "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 NDC 50580-519-30 Children's TYLENOL ® Pain Reliever Fever Reducer Acetaminophen AGES 2-6 MEDICINE PER TABLET 80 mg Meltaways™ 30 Chewable Tablets Aspirin Free • Ibuprofen Free Bubblegum Burst flavor PRINCIPAL DISPLAY PANEL" ] }, { "effective_time": "20150615", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Infants pain relief Concentrated Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel Compare to the active ingredient in Concentrated Tylenol® Infants’ Drops See New Warnings Information Concentrated Infants' Pain Relief Suspension drops Fever Reducer – Pain Reliever Acetaminophen Use only with enclosed dropper Grape Flavor 80 mg per 0.8 mL Infants Pain Relief Carton Infants Pain Relief Carton" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "46eb553e-29e7-4614-bce3-d148dfa34bf4", "id": "2046cbd7-1332-4ea8-a1ba-b8d8cc81aed6", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20140515", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "infants acetaminophen concentrated Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel See New Warnings Information Pain Reliever - Fever Reducer Infants’ Acetaminophen Concentrated Drops Aspirin Free Ibuprofen Free Alcohol Free Use only with enclosed dropper Grape Flavor Compare to Concentrated Tylenol® Infants’ Drops active ingredient 80 mg per 0.8 mL Infants' Acetaminophen Concentrated Drops Carton Infants' Acetaminophen Concentrated Drops Carton" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "5a37d549-1e79-4b4a-948e-88007540b0cf", "id": "45dea864-037d-4c6d-8b43-5ecba7fafc6d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20120111", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Acetaminophen infants Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM opaque sweet" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not give more than directed (see Liver warning) shake well before using 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 if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor replace dropper tightly to maintain child resistance this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information store at 20°-25°C (68°-77°F) do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel See New Warnings Information Acetaminophen Infant Drops Fever Reducer -Pain Reliever Use Only with Enclosed Dropper Cherry Flavor - Alcohol-Free - Aspirin-Free - Ibuprofen-Free 80 mg per 0.8 mL NDC 54868-3267-0 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146 Infants' Pain Relief Concentrated Drops package label" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache" ], "set_id": "6418498e-ed30-4bd8-a8f0-03990d32d828", "id": "e20a1904-ff41-4b58-83b3-74318c3a64ee", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20100716", "purpose": [ "Active ingredients (in each tablet) Purposes Aspirin 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine bitartrate 7.8 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 exceed recommended dosage" ], "questions": [ "Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.com" ], "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 the unborn child or complications during delivery." ], "storage_and_handling": [ "Other information each tablet contains: sodium 416 mg Phenylketonurics: Contains Phenylalanine 9 mg per tablet store at room temperature. Avoid excessive heat." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold or flu with cough: minor aches and pains nasal and sinus congestion headache sore throat cough temporarily reduces fever" ], "set_id": "66f35119-63f8-4655-af6a-201fe4c8394c", "id": "a076da72-adbd-4b9c-b3c3-a6bdd782466d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis" ], "active_ingredient": [ "Active ingredients (in each tablet) Purposes Aspirin 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine bitartrate 7.8 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate" ], "warnings": [ "Warnings Reye's syndrome Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Alcohol warning If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding. 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 if you are allergic to aspirin or any other pain reliever/fever reducer 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. in children under 12 years of age Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems heart disease diabetes ulcers high blood pressure glaucoma asthma thyroid disease cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis When using this product do not exceed recommended dosage Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, or nasal congestion 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs 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 the unborn child or complications during delivery. 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": [ "Alka-Seltzer Plus Day Non Drowsy Cold Medicine Citrus Aspirin, Dextromethorphan hydrobromide, and Phenylephrine bitartrate Aspirin Aspirin Dextromethorphan hydrobromide Dextromethorphan Phenylephrine bitartrate Phenylephrine ASP;ND" ], "ask_doctor": [ "Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems heart disease diabetes ulcers high blood pressure glaucoma asthma thyroid disease cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, or nasal congestion 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs" ], "do_not_use": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer 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. in children under 12 years of age" ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Shipper Label ALKA-SELTZER PLUS ® DAY NON-DROWSY COLD 3200 TABLETS 1600 PIECES SHIPPER CODE 1 00 16500 54212 1 MADE IN MEXICO PRODUCT CODE 82411357 STORE AT ROOM TEMPERATURE. AVOID EXCESSIVE HEAT Bayer HealthCare LLC Consumer Care P.O. Box 1910, Morristown, NJ 07962-1910 USA Principal Display Panel – Shipper Label" ], "purpose_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "leader pain reliever infants Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel See New Warnings Information Compare to Concentrated Tylenol® Infants’ Drops active ingredient Up to Age 3 Concentrated Pain Reliever Infants' Drops Acetaminophen Fever Reducer Pain Reliever Grape Flavor Use only with enclosed dropper 80 mg per 0.8 mL Pain Reliever Infants' Drops Carton Pain Reliever Infants' Drops Carton" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "66f49cbf-86a9-4b46-b319-2d253890c29d", "id": "c3429c32-e6d3-4e3e-b1ca-0fe227360d15", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "babies r us pain relief Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel Infants’ Pain Relief Acetaminophen - Concentrated Drops Fever Reducer – Pain Reliever Aspirin Free Ibuprofen Free Alcohol Free Grape Flavor Use only with enclosed dropper See New Warnings Information Compare to the active ingredient of Concentrated Tylenol® Infants’ Drops 80 mg per 0.8 mL Infants' Pain Relief Carton Image 1 Infants' Pain Relief Carton Image 2 Infants' Pain Relief Carton Image 1 Infants' Pain Relief Carton Image 2" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "6706606e-30b9-4a0a-a721-1bccd870faf3", "id": "81f0843f-c200-4305-8090-6f6d744513e8", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20150417", "purpose": [ "Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant Pseudoephedrine HCl 2.5 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." ], "when_using": [ "When using this product do not use more than directed" ], "questions": [ "Questions? 1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number." ], "storage_and_handling": [ "Other information each 5 mL contains: sodium 3 mg tamper evident: do not use if neckband on bottle cap is broken or missing store between 20-25°C (68-77°F) do not refrigerate dosing cup provided" ], "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 temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion due to a cold stuffy nose" ], "set_id": "672fc095-ff69-483e-b0ac-1dddec58f46e", "id": "fd085005-8160-4784-b144-4708731a8f50", "active_ingredient": [ "Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant Pseudoephedrine HCl 2.5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children 6 years to under 12 years 10 mL every 4 hours
children 4 years to under 6 years 5 mL every 4 hours
children under 4 years do not use
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, D&C red #33, dextrose, FD&C blue #1, FD&C red #40, flavors, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum" ], "warnings": [ "Warnings Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma When using this product do not use more than directed Stop use and ask a doctor if your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever 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." ], "spl_product_data_elements": [ "Childrens Mucinex Multi-Symptom Cold Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin Phenylephrine Hydrochloride Phenylephrine anhydrous citric acid D&C red no. 33 dextrose FD&C blue no. 1 FD&C red no. 40 glycerin methylparaben potassium sorbate propyl gallate propylene glycol propylparaben water saccharin sodium sodium hydroxide sorbitol sucralose xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma" ], "openfda": {}, "version": "8", "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 dose as follows or as directed by a doctor mL = milliliter Age Dose children 6 years to under 12 years 10 mL every 4 hours children 4 years to under 6 years 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 your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness." ], "do_not_use": [ "Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product." ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL) Purpose
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
Pseudoephedrine HCl 2.5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton NEW VALUE SIZE! NDC 63824-010-67 Children's Mucinex ® Multi-Sympton Cold Expectorant Cough Suppressant Nasal Decongestant Guaifenesin 100 mg Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg ✓ Stuffy Nose ✓ Cough ✓ Chest Congestion ✓ Breaks up Mucus Very Berry Flavor Liquid 6.8 FL OZ (201 mL) Principal Display Panel - 201 mL Bottle Carton" ], "purpose_table": [ "
Active ingredients (in each 5 mL) Purpose
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
Pseudoephedrine HCl 2.5 mg Nasal decongestant
" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Pain Relief infants Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel Compare to Concentrated Tylenol® Infants’ Drops active ingredient For Ages 2 to 3 Infants’ Pain Relief Acetaminophen Concentrated Drops Fever Reducer/Pain Reliever Aspirin Free Ibuprofen Free Alcohol Free Grape Flavor Infants' Use only with enclosed dropper 80 mg per 0.8 mL Infants' Pain Relief Carton Image #1 Infants' Pain Relief Carton Image #2 Infants' Pain Relief Carton Image #1 Infants' Pain Relief Carton Image #2" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "697ae4c3-0f1d-47b8-90a4-1ea5f59e036c", "id": "be81c4dc-eed2-4d5f-a9cc-8e6cbe281198", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-888-423-0139" ], "spl_product_data_elements": [ "Topcare Infants Pain Relief Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel See New Warnings Information Infants’ Pain Relief Acetaminophen Concentrated Drops Fever Reducer – Pain Reliever Aspirin Free Ibuprofen Free Alcohol Free Grape Flavor Use only with enclosed dropper Compare to Concentrated Tylenol® Infants’ Drops active ingredient 80 mg per 0.8 mL Infants' Pain Relief Carton Infants' Pain Relief Carton" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "6cccf326-0007-4b20-afed-538e7534f297", "id": "daf08b48-f7d6-4fa5-8efc-cd9efdb3e6b9", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20110602", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information each 5 mL (1 tsp) contains: sodium 2 mg store between 20-25°C (68-77°F) do not use if neck wrap or foil inner seal imprinted with \"SAFETY SEAL®\" is broken or missing see top panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache" ], "set_id": "6da76108-1403-44b1-88a0-e137b0c7a32f", "id": "ea50c23c-279b-4fe7-bf49-8987002ec740", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (mL or tsp) or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL (1 tsp)
36-47 4-5 years 7.5 mL (1½ tsp)
48-59 6-8 years 10 mL (2 tsp)
60-71 9-10 years 12.5 mL (2½ tsp)
72-95 11 years 15 mL (3 tsp)
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum" ], "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. 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 this product do not exceed recommended dose (see overdose warning ) 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens Tylenol acetaminophen acetaminophen acetaminophen anhydrous citric acid butylparaben D&C red NO. 33 FD&C blue NO. 1 glycerin high fructose corn syrup cellulose, microcrystalline carboxymethylcellulose sodium propylene glycol water sodium benzoate sorbitol xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "3", "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 ) shake well before using mL = milliliter; tsp = teaspoonful find right dose on chart below. If possible, use weight to dose; otherwise, use age. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL or tsp) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL (1 tsp) 36-47 4-5 years 7.5 mL (1½ tsp) 48-59 6-8 years 10 mL (2 tsp) 60-71 9-10 years 12.5 mL (2½ tsp) 72-95 11 years 15 mL (3 tsp) Attention : use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "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." ], "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 See New Warnings Information NDC 50580-318-10 Children's TYLENOL ® Acetaminophen Oral Suspension Pain Reliever, Fever Reducer AGES 2-11 Pediatricians' 1st Choice Alcohol Free Aspirin Free Ibuprofen Free grape FLAVOR 3.38 fl oz (100ml) 80 mg per ½ teaspoon (160 mg per 5 mL) Principal Display Panel" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Sunmark Pain Reliever infants Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel Compare to Concentrated Tylenol® Infants’ Drops active ingredient See New Warnings Information Pain Reliever Infants' Concentrated Drops Pain Reliever Fever Reducer Aspirin Free Ibuprofen Free Alcohol Free Acetaminophen Use only with enclosed dropper Grape Flavor Gluten Free 80 mg per 0.8 mL Pain Reliever Carton Image #1 Pain Reliever Carton Image #2 Pain Reliever Carton Image #1 Pain Reliever Carton Image #2" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "7058a2c6-be71-462b-bdaa-41ae94b512ca", "id": "96281500-48a4-4b43-a81b-bdb70de13685", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20121208", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) tamper evident statement" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache" ], "set_id": "706ec440-a24e-4d90-a1dc-be7630dc7281", "id": "84f0712b-d92d-4ed3-961a-5510dac09580", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (mL or tsp) or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL (1 tsp)
36-47 4-5 years 7.5 mL (1½ tsp)
48-59 6-8 years 10 mL (2 tsp)
60-71 9-10 years 12.5 mL (2½ tsp)
72-95 11 years 15 mL (3 tsp)
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sorbitol solution, sucralose, sucrose, xanthan gum" ], "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. 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 this product do not exceed recommended dose (see overdose warning ) 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens Tylenol Acetaminophen Acetaminophen acetaminophen anhydrous citric acid butylparaben glycerin cellulose, microcrystalline carboxymethylcellulose sodium propylene glycol propylparaben water sorbitol sucralose sucrose xanthan gum Off-white Cherry Blast" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "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 ) shake well before using mL = milliliter; tsp = teaspoonful find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child's dose into the dosing cup repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL or tsp) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL (1 tsp) 36-47 4-5 years 7.5 mL (1½ tsp) 48-59 6-8 years 10 mL (2 tsp) 60-71 9-10 years 12.5 mL (2½ tsp) 72-95 11 years 15 mL (3 tsp) Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "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." ], "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 Principal Display Panel" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "pain relief infants Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel See New Warnings Information Compare to Concentrated Tylenol® Infants’ Drops active ingredient Infants’ Pain Relief Concentrated Drops Acetaminophen Fever Reducer Pain Reliever Use only with enclosed dropper Grape Flavor 80 mg per 0.8 mL Infants' Pain Relief Carton Image 1 Infants' Pain Relief Carton Image 2 Infants' Pain Relief Carton Image 1 Infants' Pain Relief Carton Image 2" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "71095069-7cc3-405d-bfdc-088b4d246e39", "id": "362d490c-34e4-4862-b17b-c0aa467bf14c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20140417", "purpose": [ "Purpose Pain reliever/fever reducer" ], "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)" ], "when_using": [ "When using this product mouth or throat burning may occur; give with food or water take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? Call 1-877-895-3665: weekdays 8:00 AM to 8:00 PM EST" ], "storage_and_handling": [ "Other information phenylketonurics: contains phenylalanine 2.8 mg per tablet store between 20-25°C (68-77°F) do not use if neck wrap or foil inner seal imprinted \"Safety Seal®\" is broken or missing see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches" ], "set_id": "7285807f-8196-4f1e-8f10-6b69a8ab250a", "id": "dabe18f7-05fe-483d-8038-2fda05c83715", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 100 mg (NSAID) nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Dosing Chart
Weight (lb) Age (yr) Tablets
under 24 under 2 ask a doctor
24-35 2-3 1
36-47 4-5 1 ½
48-59 6-8 2
60-71 9-10 2 ½
72-95 11 3
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavor, fumaric acid, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate" ], "warnings": [ "Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child: 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 Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product mouth or throat burning may occur; give with food or water take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear 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)" ], "spl_product_data_elements": [ "Motrin Junior Strength Ibuprofen Ibuprofen Ibuprofen acesulfame potassium anhydrous citric acid aspartame FD&C yellow NO. 6 aluminum oxide fumaric acid hypromelloses magnesium stearate mannitol cellulose, microcrystalline povidones sodium lauryl sulfate sodium starch glycolate type a potato MO;100" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use do not give more than directed find right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47 4-5 1 ½ 48-59 6-8 2 60-71 9-10 2 ½ 72-95 11 3" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL See New Warnings Information NDC 50580-207-24 Motrin ® Junior Strength For Ages 2 to 11 Lasts up to 8 hours contains Ibuprofen Tablets (NSAID), 100 mg Pain Reliever / Fever Reducer 24 Orange-Flavored Chewable Tablets Principal Display Panel" ] }, { "effective_time": "20150814", "inactive_ingredient": [ "Inactive ingredients ammonium acrylyoyldimethyltaurate/beheneth-25 methacrylate crosspolymer, anhydrous citric acid, butyrospermum parkii (shea butter) fruit, diazolidinyl urea, dimethicone, disodium lauriminodipropionate tocopheryl phosphates, edetate disodium, ethylhexylglycerin, euphorbia cerifera (candelilla) wax, glycerin, hydroxyethyl behenamidopropyl dimonium chloride, iodopropynyl butylcarbamate, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, purified water, silica, sodium citrate, sodium hydroxide, tetrahexyldecyl ascorbate, vitamin E, xanthan gum" ], "purpose": [ "Purpose Benzoyl peroxide - Acne treatment" ], "keep_out_of_reach_of_children": [ "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 Do not use if you have very sensitive skin or if you are sensitive to benzoyl peroxide When using this product • avoid unnecessary sun exposure and use a sunscreen • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used. • irritation may develop, such as redness, burning, itching, peeling or possibly swelling • more frequent use or higher concentrations may aggravate such irritation • mild irritation may be reduced by using product less frequently or in a lower concentration • keep away from eyes, lips and mouth • IT MAY BLEACH HAIR OR DYED FABRICS Stop use and ask a doctor if if irritation becomes severe and continues Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product • avoid unnecessary sun exposure and use a sunscreen • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used. • irritation may develop, such as redness, burning, itching, peeling or possibly swelling • more frequent use or higher concentrations may aggravate such irritation • mild irritation may be reduced by using product less frequently or in a lower concentration • keep away from eyes, lips and mouth • IT MAY BLEACH HAIR OR DYED FABRICS" ], "questions": [ "Questions? Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST)" ], "spl_product_data_elements": [ "OXY Clinical Clearing Treatment Benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • cleanse skin thoroughly before applying • cover entire affected area with a thin layer 1 to 3 times daily • because excessive drying of the skin, may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day • if going outside, use a sunscreen . Allow OXY® Clinical Clearing Treatment to dry, then follow directions in the sunscreen labeling. • if irritation or sensitivity develops, stop use of both products and ask a doctor Other information • avoid storing at temperatures above 100°F" ], "stop_use": [ "Stop use and ask a doctor if if irritation becomes severe and continues" ], "do_not_use": [ "Do not use if you have very sensitive skin or if you are sensitive to benzoyl peroxide" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel OXY Clinical Clearing Treatment Acne Treatment 5% Benzoyl Peroxide Clinical results without a prescription The Mentholatum Company Orchard Park, NY 14127 www.oxyclinical.com OXY Clinical Clearing Treatment Acne Treatment Clinical Results without a prescription" ], "indications_and_usage": [ "Uses treats and helps prevent acne blemishes" ], "set_id": "74dbafbb-6b6c-471c-b4fe-73cf4584ed30", "id": "a87e9903-557a-4bcf-9add-ac9896360496", "active_ingredient": [ "Active ingredient Benzoyl peroxide 5%" ] }, { "effective_time": "20140610", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F). Avoid high humidity. Protect from light. do not use if carton is opened, or if neck wrap or foil inner seal imprinted with \"SAFETY SEAL®\" is broken or missing see end panel for lot number and expiration date" ], "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": "7503b882-a815-4a8a-a845-a1d7e40757b2", "id": "b06c66b2-2b1a-4af3-93bc-d72dac313727", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tablets)or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 2-3 years 2 tablets
36-47 4-5 years 3 tablets
48-59 6-8 years 4 tablets
60-71 9-10 years 5 tablets
72-95 11 years 6 tablets
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose excipient, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose" ], "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. 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 this product do not exceed recommended dose (see overdose warning ) 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. Keep out of reach of children." ], "spl_product_data_elements": [ "Childrens TYLENOL Acetaminophen Acetaminophen Acetaminophen anhydrous citric acid cellulose acetate crospovidone D&C red no. 30 aluminum oxide FD&C blue no. 1 magnesium stearate povidones sucralose TY;80 Grape Punch" ], "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. do not give more than directed (see overdose warning ) find right dose on chart below. If possible, use weight to dose; otherwise, use age. chew before swallowing; this product will soften in mouth for ease of chewing repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 2 tablets 36-47 4-5 years 3 tablets 48-59 6-8 years 4 tablets 60-71 9-10 years 5 tablets 72-95 11 years 6 tablets" ], "spl_unclassified_section": [ "Drug Facts", "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 for adults as well as for children even if you do not notice any signs or symptoms." ], "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." ], "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 NDC 50580-518-30 Children's TYLENOL ® Pain Reliever Fever Reducer Acetaminophen AGES 2-6 MEDICINE PER TABLET 80 mg Meltaways™ 30 Chewable Tablets Aspirin Free • Ibuprofen Free Grape Punch flavor PRINCIPAL DISPLAY PANEL" ] }, { "effective_time": "20121227", "purpose": [ "Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine Phenylephrine HCl 2.5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted \"Safety Seal®\" is broken or missing see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses for the temporary relief of the following cold and hay fever or other upper respiratory allergy symptoms: minor aches and pains headache sore throat itchy, watery eyes itching of the nose or throat sneezing runny nose nasal congestion stuffy nose temporarily reduces fever" ], "set_id": "7523ac1e-c056-4784-ba5f-c4f53c8873a3", "id": "59b7b7c6-5a48-461e-9cac-b0032434267f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine Phenylephrine HCl 2.5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tsp or mL)
under 36 under 4 years do not use
36-47 4 to 5 years do not use unless directed by a doctor
48-95 6 to 11 years 2 tsp or 10 mL
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum" ], "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. to make a child sleepy with any other product containing diphenhydramine, even one used on the skin in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dose (see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain or nasal congestion gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens Tylenol Plus Cold and Allergy Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride Acetaminophen acetaminophen Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride phenylephrine anhydrous citric acid carboxymethylcellulose sodium D&C Red NO. 33 FD&C Red NO. 40 glycerin cellulose, microcrystalline water sodium benzoate sorbitol sucralose sucrose xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis glaucoma" ], "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 ) shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tsp or mL) under 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 2 tsp or 10 mL Attention use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain or nasal congestion gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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. to make a child sleepy with any other product containing diphenhydramine, even one used on the skin in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL = 1 teaspoon) Purpose
Acetaminophen 160 mg Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg Antihistamine
Phenylephrine HCl 2.5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL See New Warnings Information NDC 50580-390-04 Children's TYLENOL ® Plus COLD & ALLERGY Fever & Sore Throat Acetaminophen Itchy, Watery Eyes, Sneezing & Runny Nose Diphenhydramine HCl Stuffy Nose Phenylephrine HCl BUBBLE GUM FLAVOR 4 FL OZ (120mL) ORAL SUSPENSION Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each 5 mL = 1 teaspoon) Purpose
Acetaminophen 160 mg Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg Antihistamine
Phenylephrine HCl 2.5 mg Nasal decongestant
" ] }, { "effective_time": "20140313", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F). Avoid high humidity. do not use if carton or blister unit is opened or broken see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: the common cold flu headache sore throat temporarily reduces fever" ], "set_id": "7647e315-2fbc-4925-ab15-a7cc4a7d6d28", "id": "c090c4b5-c728-4be3-ac19-0fbc9e6c99a4", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 160 mg" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tablets) or as directed by a doctor
under 48 under 6 years ask a doctor
48-59 6-8 years 2 tablets
60-71 9-10 years 2½ tablets
72-95 11 years 3 tablets
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, flavor, magnesium stearate, povidone, sucralose" ], "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. 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 this product do not exceed recommended dose (see overdose warning ) 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Jr TYLENOL Acetaminophen Acetaminophen Acetaminophen anhydrous citric acid cellulose acetate crospovidone magnesium stearate povidones sucralose TY;160" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "3", "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 below. If possible, use weight to dose; otherwise, use age. chew before swallowing; this product will soften in mouth for ease of chewing repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets) or as directed by a doctor under 48 under 6 years ask a doctor 48-59 6-8 years 2 tablets 60-71 9-10 years 2½ tablets 72-95 11 years 3 tablets" ], "spl_unclassified_section": [ "Drug Facts" ], "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." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-513-24 Jr. TYLENOL ® Acetaminophen Pain Reliever-Fever Reducer For Children AGES 6-11 ∙ MEDICINE PER TABLET ∙ 160 mg Meltaways ™ 24 Chewable Tablets Aspirin Free ∙ Ibuprofen Free Bubblegum Burst flavor PRINCIPAL DISPLAY PANEL" ] }, { "effective_time": "20121227", "purpose": [ "Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted \"Safety Seal®\" is broken or missing see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat cough stuffy nose sneezing and runny nose temporarily reduces fever" ], "set_id": "77d8abd6-1c54-43be-9b12-2026bf4a9751", "id": "98488af1-98d1-4222-b793-6cfc2f1b5e6b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tsp or mL)
under 36 under 4 years do not use
36-47 4 to 5 years do not use unless directed by a doctor
48-95 6 to 11 years 2 tsp or 10 mL
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum" ], "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. to make a child sleepy in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dose (see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens Tylenol Plus Multi-Symptom Cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Chlorpheniramine Maleate Chlorpheniramine Dextromethorphan Hydrobromide Dextromethorphan Phenylephrine Hydrochloride Phenylephrine anhydrous citric acid D&C Red No. 33 FD&C Blue No. 1 FD&C Red No. 40 glycerin cellulose, microcrystalline carboxymethylcellulose sodium water sodium benzoate sorbitol sucrose xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) a breathing problem such as chronic bronchitis glaucoma" ], "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 ) shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tsp or mL) under 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 2 tsp or 10 mL Attention use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 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. to make a child sleepy in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL = 1 teaspoon) Purpose
Acetaminophen 160 mg Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg Antihistamine
Dextromethorphan HBr 5 mg Cough suppressant
Phenylephrine HCl 2.5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL See New Warnings Information NDC 50580-391-04 Children's TYLENOL ® Plus MULTI-SYMPTOM COLD Fever & Sore Throat Acetaminophen Cough Dextromethorphan HBr Stuffy Nose Phenylephrine HCl Sneezing & Runny Nose Chlorpheniramine Maleate GRAPE FLAVOR 4 FL OZ (120mL) ORAL SUSPENSION Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each 5 mL = 1 teaspoon) Purpose
Acetaminophen 160 mg Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg Antihistamine
Dextromethorphan HBr 5 mg Cough suppressant
Phenylephrine HCl 2.5 mg Nasal decongestant
" ] }, { "effective_time": "20110615", "purpose": [ "PURPOSE Pain reliever/Fever reducer" ], "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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not use more than directed" ], "questions": [ "QUESTIONS OR COMMENTS? Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "USES temporarily relieves these symptoms associated with a cold, or flu: headache sore throat minor aches and pains temporarily reduces fever" ], "set_id": "7aaaa036-f3c5-b5a8-f73e-8b3b4fe0e83c", "id": "16802cff-d5d9-0e17-2fe8-50ce1b6c1a2d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin taking any other pain reliever/fever reducer" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH 5 ML TSP) Acetaminophen, USP 160 mg" ], "dosage_and_administration_table": [ "
age dose
12 years and over 4 teaspoons every 4 hours
6 to under 12 years 2 teaspoons every 4 hours
4 to under 6 years 1 1/2 teaspoons every 4 hours
2 to under 4 years 1 teaspoon every 4 hours
under 2 years do not use
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous citric acid, glycerin, high fructose corn syrup, menthol, natural flavor, polyethylene glycol, propylene glycol, purified honey, purified water, sodium benzoate, sodium citrate, sucralose" ], "warnings": [ "WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if user takes more than 5 doses in any 24-hour period, which is the maximum daily amount taken with other drugs containing acetaminophen adult takes 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. Do not use in a child under 2 years of age 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 user has liver disease Ask a doctor or pharmacist before use if user is taking the blood thinning drug warfarin taking any other pain reliever/fever reducer When using this product do not use more than directed Stop use and ask a doctor if pain gets worse or lasts more than 5 days (children) or 10 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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. Prompt 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": [ "CHILDRENS DIMETAPP FEVER AND SORE THROAT acetaminophen acetaminophen acetaminophen anhydrous citric acid glycerin high fructose corn syrup honey menthol polyethylene glycol propylene glycol sodium benzoate sodium citrate sucralose water translucent, golden-amber liquid 4 mg sodium, 5 mg potassium" ], "ask_doctor": [ "Ask a doctor before use if user has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than 5 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. age dose 12 years and over 4 teaspoons every 4 hours 6 to under 12 years 2 teaspoons every 4 hours 4 to under 6 years 1 1/2 teaspoons every 4 hours 2 to under 4 years 1 teaspoon every 4 hours under 2 years do not use" ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION each teaspoon contains: sodium 4 mg and potassium 5 mg store at 20-25°C (68-77°F) dosage cup provided" ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 5 days (children) or 10 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur" ], "do_not_use": [ "Do not use in a child under 2 years of age 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": [ "PRODUCT PACKAGING The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. NEW Children’s Dimetapp Fever & Sore Throat ACETAMINOPHEN (Pain Reliever/Fever Reducer) For Ages 2 Years & Older Natural Grade ‘A’ Honey Relieves Fever Sore Throats Minor Aches & Pains Headaches For Ages 2 Yrs. & Over 4 FL OZ (118 ml) For most recent product information, visit www.dimetapp.com We pledge to you that Dimetapp products contain only high quality ingredients and meet strict standards of quality and safety. You can trust Dimetapp products for your family. Dosing cup to be used with Children’s Dimetapp Fever & Sore Throat only. Pfizer Pfizer, Madison, NJ 07940 USA © 2011 Pfizer Inc. Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. Children's Dimetapp Fever and Sore Throat Packaging" ] }, { "effective_time": "20131108", "purpose": [ "Purpose Pain reliever/fever reducer 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. (1-800-222-1222)" ], "when_using": [ "When using this product do not exceed recommended dosage take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? Call 1-877-895-3665 ( English ) or 1-888-466-8746 ( Spanish ): weekdays 9:00 AM to 4:30 PM EST" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted with \"Safety Seal ® \" is broken or missing see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these cold, sinus and flu symptoms: nasal and sinus congestion stuffy nose headache sore throat minor body aches and pains fever" ], "set_id": "7d28682b-fc7d-4c2b-9a83-89df25b5ab2d", "id": "68248a98-3b9f-426d-ac1b-33dfd68aa030", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking any other drug containing an NSAID (prescription or nonprescription) and/or pseudoephedrine or any other nasal decongestant taking a blood thinning (anticoagulant) or steroid drug under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredients (in each 5 mL = 1 teaspoon) Ibuprofen 100 mg (NSAID) nonsteroidal anti-inflammatory drug Pseudoephedrine HCl 15 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
Weight (lb) Age (yrs) Dose (tsp or mL)
under 24 under 2 ask a doctor
24-47 2 to 5 1 tsp or 5 mL
48-95 6 to 11 2 tsp or 10 mL
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum" ], "warnings": [ "Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer and/or nasal decongestant right before or after heart surgery in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has problems or serious side effects from taking pain relievers, fever reducers, or nasal decongestants stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems not been drinking fluids lost a lot of fluid due to vomiting or diarrhea high blood pressure heart or kidney disease asthma thyroid disease diabetes taken a diuretic Ask a doctor or pharmacist before use if the child is taking any other drug containing an NSAID (prescription or nonprescription) and/or pseudoephedrine or any other nasal decongestant taking a blood thinning (anticoagulant) or steroid drug under a doctor's care for any serious condition taking any other drug When using this product do not exceed recommended dosage take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. stomach pain or upset gets worse or lasts the child does not get any relief within first day (24 hours) of treatment fever, pain, or nasal congestion gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear the child gets nervous, dizzy, or sleepless 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)" ], "spl_product_data_elements": [ "Childrens Motrin Cold Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen Ibuprofen Pseudoephedrine Hydrochloride Pseudoephedrine acesulfame potassium anhydrous citric acid D&C yellow no. 10 FD&C red no. 40 glycerin polysorbate 80 water sodium benzoate sucrose xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if the child has problems or serious side effects from taking pain relievers, fever reducers, or nasal decongestants stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems not been drinking fluids lost a lot of fluid due to vomiting or diarrhea high blood pressure heart or kidney disease asthma thyroid disease diabetes taken a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use do not give more than directed do not give longer than 10 days, unless directed by a doctor (see Warnings ) shake well before using find right dose on chart below. If possible, use weight to dose; otherwise use age. only use enclosed measuring cup if needed, repeat dose every 6 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) Age (yrs) Dose (tsp or mL) under 24 under 2 ask a doctor 24-47 2 to 5 1 tsp or 5 mL 48-95 6 to 11 2 tsp or 10 mL" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. stomach pain or upset gets worse or lasts the child does not get any relief within first day (24 hours) of treatment fever, pain, or nasal congestion gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear the child gets nervous, dizzy, or sleepless" ], "do_not_use": [ "Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer and/or nasal decongestant right before or after heart surgery in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-902-04 For Ages 2 to 11 Children's Motrin ® COLD contains Ibuprofen (NSAID) Pseudoephedrine HCl Oral Suspension 100 mg/15 mg per 5 mL (teaspoon) Pain Reliever/Fever Reducer/Nasal Decongestant Relieves: Stuffy Nose (Pseudoephedrine HCl) Sore Throat (Ibuprofen) Fever (Ibuprofen) Original Berry Flavor Alcohol Free 4 FL OZ (120 mL) PRINCIPAL DISPLAY PANEL - 120 mL Carton" ] }, { "effective_time": "20150303", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, cocoa, maltitol, methylparaben, natural flavor, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate" ], "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 persistent or chronic cough such as occurs with smoking, asthma, 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 or comments? call 1-855-848-3284 toll free" ], "spl_product_data_elements": [ "Dr. Cocoa Non-Drowsy Cough Dextromethorphan Hydrobromide ANHYDROUS CITRIC ACID COCOA MALTITOL METHYLPARABEN PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE TRISODIUM CITRATE DIHYDRATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN" ], "ask_doctor": [ "Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions shake well before use measure only with dosing spoon provided read dosing sppon carefully. Dosing spoon holds 5 mL when filled to the top rim do not use dosing spoon with other products dose as follows or as directed by a doctor mL = milliter Dosing Cart" ], "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 5 mL contains: sodium 7 mg 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 - 120 mL Bottle Label NDC 65224-700-04 Dr. Cocoa™ .................... for Children Non-Drowsy Cough Dextromethorphan HBr, 7.5 mg (Cough Suppressant) For Ages 4+ 120 mL (4 FL OZ) Dr. Cocoa Non-Drowsy Cough Bottle Label", "PRINCIPAL DISPLAY PANEL - 120 mL Carton NDC 65224-700-04 NEW! Dr. Cocoa™ .................... for Children Non-Drowsy Cough Dextromethorphan HBr, 7.5 mg (Cough Suppressant) Relieves: Cough up to 8 hours For Ages 4+ Real Chocolate Taste 120 mL (4 FL OZ) Dr. Cocoa Non-Drowsy Cough Carton" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritations as may occur with a cold" ], "set_id": "7ef788b7-8c1f-40ad-9c35-24e5d35eda4f", "id": "10649933-1544-4f38-e054-00144ff8d46c", "active_ingredient": [ "Drug Facts Active ingredient (in each 5 mL) Dextromethorphan HBr 7.5 mg Purpose Cough suppressant" ] }, { "effective_time": "20120625", "purpose": [ "Active ingredients (in each 20 mL) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant 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 use more than directed" ], "questions": [ "Questions? 1-866-MUCINEX (1-866-682-4639) 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 20 mL contains: sodium 14 mg tamper evident: do not use if neckband on bottle cap is broken or missing store between 20-25°C (68-77°F) do not refrigerate dosing cup provided" ], "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 temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold" ], "set_id": "7f4ccd7c-9b17-428b-8cdf-42237728f9b2", "id": "34aa33c3-2663-496b-bd18-3a3441533126", "active_ingredient": [ "Active ingredients (in each 20 mL) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient , xanthan gum" ], "warnings": [ "Warnings Do not use for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, phsychiatric, 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 trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever 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. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Mucinex Fast-Max Severe Congestion and Cough Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin Phenylephrine Hydrochloride Phenylephrine Anhydrous Citric Acid Edetate Disodium FD&C Blue No. 1 FD&C Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Trisodium Citrate Dihydrate Xanthan Gum" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)" ], "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 dose as follows or as directed by a doctor mL = milliliter Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours. Children under 12 years of age: Do not use." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, phsychiatric, 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 20 mL) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label MAXIMUM STRENGTH NDC 63824-014-69 Mucinex ® FAST- MAX ™ Severe Congestion & Cough Dextromethorphan HBr • Cough Suppressant Guaifenesin • Expectorant Phenylephrine HCl • Nasal Decongestant VALUE SIZE! ✔ Controls Cough ✔ Relieves Nasal & Chest Congestion ✔ Thins & Loosens Mucus 9 fl oz (266 mL) For Ages 12+ PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 20 mL) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
" ] }, { "effective_time": "20150123", "purpose": [ "Active ingredients (in each 15 mL = 1 tablespoon) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage 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 or comments? call 1-877-895-3665" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains: sodium 5 mg store between 20-25°C (68-77°F). Do not refrigerate. do not use if plastic neck wrap or foil inner seal imprinted with \"Safety Seal®\" is broken or missing see back label for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion runny nose and sneezing cough sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever" ], "set_id": "8065073e-1bab-4708-827b-bed6f6b52da0", "id": "bfbe24ef-ea78-4dff-8cde-dbb2ef324507", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each 15 mL = 1 tablespoon) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 tablespoons (tbsp) or 30 mL in dose cup provided every 4 hours do not take more than 12 tablespoons (tbsp) or 180 mL in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 tablespoons 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. 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage 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 nervousness, dizziness, or sleeplessness occur pain, nasal congestion 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 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "TYLENOL COLD Multi-Symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate, and Phenylephrine Hydrochloride Acetaminophen acetaminophen Dextromethorphan Hydrobromide dextromethorphan Doxylamine succinate doxylamine Phenylephrine Hydrochloride phenylephrine anhydrous citric acid FD&C blue NO. 1 FD&C red NO. 40 FD&C yellow NO. 6 glycerin propylene glycol water sodium benzoate sorbitol sucralose amber colored" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 2 tablespoons (tbsp) or 30 mL in dose cup provided every 4 hours do not take more than 12 tablespoons (tbsp) or 180 mL in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion 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. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each 15 mL = 1 tablespoon) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-352-08 See New Warnings Information TYLENOL ® Warming COLD MULTI-SYMPTOM Alleviates Head & Body Aches Reduces Fever Acetaminophen Dries Runny Nose Doxylamine Succinate Controls Cough Dextromethorphan HBr Clears Stuffy Nose Phenylephrine HCI NIGHTTIME HONEY LEMON 8 FL OZ (240 mL) Liquid Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each 15 mL = 1 tablespoon) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20151104", "inactive_ingredient": [ "Inactive ingredients Anhydrous citric acid, disodium hydrogen phosphate, Water" ], "purpose": [ "Purpose For antiseptic application at procedure site." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children : if swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings ​For External Use Only Avoid contact with the eyes . If contact occurs, flush with water. ​​" ], "spl_product_data_elements": [ "Dual Swab Scrub Swabstick Povidone Iodine POVIDONE-IODINE IODINE ANHYDROUS CITRIC ACID SODIUM PHOSPHATE, DIBASIC ANHYDROUS WATER" ], "ask_doctor": [ "Ask a doctor Ask a doctor before use if you have deep puncture wounds animal bites serious wounds" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and administration Directions For preoperative patient skin preparation: Apply to procedure siteand allow to dry. Discard after single use.If not ready for immediate venipuncture, cover the area with a dry sterile gauze. As a first aid antiseptic: clean affected area apply to wound once or twice daily may be covered with a sterile bandage if bandaged, let dry first. Tear at notch, remove applicator, use only once." ], "stop_use": [ "Stop use Stop use and ask a healthcare professional if, condition worsens or persists for more than 72 hours if pain, irritation, redness or swelling occurs" ], "spl_unclassified_section": [ "Other information Store at room temperature Avoid excessive heat" ], "do_not_use": [ "Do not use Do not use: as a first aid antiseptic for more than 1 week over large areas of the body" ], "package_label_principal_display_panel": [ "Principal Display Panel Dynarex Dual Swab Povidone Iodine Prep Swabstick Item #: 1210 1210 Prep.jpg Prep Swabstick" ], "indications_and_usage": [ "Indications and usage For pre-operative patient skin preparation." ], "set_id": "8092e6e8-467a-4260-977f-96c509c64832", "id": "e790de87-37b9-4859-bb5a-265767a309ea", "active_ingredient": [ "Active Ingredient Active ingredient Purpose Povidone iodine 10% Antiseptic" ] }, { "effective_time": "20121210", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains: sodium 9 mg store between 20-25°C (68-77°F) do not use if plastic neck wrap or foil inner seal imprinted with \"Safety Seal®\" is broken or missing see back label for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever" ], "set_id": "81f3847f-99e8-4ff3-ad18-f8b8e1c54238", "id": "5a42290a-810c-427c-a406-2df70a02c372", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 15 mL = 1 tablespoon) Acetaminophen 500 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 tablespoons (tbsp) or 1 oz in dosing cup provided every 4 to 6 hours while symptoms last do not take more than 8 tablespoons (tbsp) or 4 oz in 24 hours do not take for more than 10 days unless directed by a doctor
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablespoons (tbsp) or 4 oz 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 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 allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 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. 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. ( 1-800-222-1222 ) 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": [ "Tylenol Extra Strength Acetaminophen Acetaminophen Acetaminophen anhydrous citric acid D&C Red NO. 33 FD&C Red NO. 40 high fructose corn syrup polyethylene glycols propylene glycol water saccharin sodium sodium benzoate sorbitol" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 2 tablespoons (tbsp) or 1 oz in dosing cup provided every 4 to 6 hours while symptoms last do not take more than 8 tablespoons (tbsp) or 4 oz in 24 hours do not take for more than 10 days unless directed by a doctor children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 10 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." ], "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 allergic to acetaminophen or any of the inactive ingredients in this product" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-111-08 See New Warnings Information TYLENOL ® Pain Reliever Fever Reducer EXTRA STRENGTH Acetaminophen ADULT Rapid Blast LIQUID CHERRY flavor 500 mg per 15 mL 8 FL OZ (240 mL) Principal Display Panel" ] }, { "effective_time": "20150415", "purpose": [ "Active ingredients (in each 5 mL) Purpose Guaifenesin 100 mg Expectorant Phenylephrine HCl 2.5 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." ], "when_using": [ "When using this product do not use more than directed" ], "questions": [ "Questions? 1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number." ], "storage_and_handling": [ "Other information each 5 mL contains: sodium 3 mg tamper evident: do not use if neckband on bottle cap is broken or missing store between 20-25°C (68-77°F) do not refrigerate dosing cup provided" ], "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 temporarily relieves: nasal congestion due to a cold stuffy nose" ], "set_id": "826b4389-4650-4037-aba0-d9966bc11558", "id": "6a4cf57c-88a5-42b7-9774-39df8f1d004a", "active_ingredient": [ "Active ingredients (in each 5 mL) Purpose Guaifenesin 100 mg Expectorant Phenylephrine HCl 2.5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children 6 years to under 12 years 10 mL every 4 hours
children 4 years to under 6 years 5 mL every 4 hours
children under 4 years do not use
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, dextrose, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum" ], "warnings": [ "Warnings Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma When using this product do not use more than directed Stop use and ask a doctor if your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever 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." ], "spl_product_data_elements": [ "Childrens Mucinex Stuffy Nose and Cold Guaifenesin and Phenylephrine Hydrochloride Guaifenesin Guaifenesin Phenylephrine Hydrochloride Phenylephrine anhydrous citric acid dextrose D&C red No. 33 FD&C blue No. 1 FD&C red No. 40 glycerin methylparaben potassium sorbate propyl gallate propylene glycol propylparaben water saccharin sodium sodium hydroxide sorbitol sucralose xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma" ], "openfda": {}, "version": "5", "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 10 mL every 4 hours children 4 years to under 6 years 5 mL every 4 hours children under 4 years do not use" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224" ], "stop_use": [ "Stop use and ask a doctor if your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness." ], "do_not_use": [ "Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product." ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL) Purpose
Guaifenesin 100 mg Expectorant
Phenylephrine HCl 2.5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton NDC 63824-277-64 Children's Mucinex ® Stuffy Nose & Cold Expectorant Nasal Decongestant Guaifenesin 100 mg Phenylephrine HCl 2.5 mg ✓ Stuffy Nose ✓ Chest Congestion ✓ Breaks up Mucus Mixed Berry Flavor Liquid 4 FL OZ (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton" ], "purpose_table": [ "
Active ingredients (in each 5 mL) Purpose
Guaifenesin 100 mg Expectorant
Phenylephrine HCl 2.5 mg Nasal decongestant
" ] }, { "effective_time": "20131121", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if carton is opened or neck wrap or foil inner seal imprinted with \"Safety Seal®\" is broken or missing see end panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: the common cold headache backache toothache minor pain of arthritis muscular aches premenstrual and menstrual cramps temporarily reduces fever" ], "set_id": "83320cd8-3024-418a-ba45-49c72359a5f9", "id": "ac2271ee-5d91-42c8-92c3-140bd74a3088", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 500 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 8 tablets in 24 hours do not use for more than 10 days unless directed by a doctor
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide, magnesium stearate, polyethylene glycol, polyvinyl alcohol, potassium sorbate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, talc, titanium dioxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets 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 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 allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 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. 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. (1-800-222-1222) 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": [ "TYLENOL Extra Strength Acetaminophen Acetaminophen Acetaminophen anhydrous citric acid carnauba wax starch, corn D&C yellow no. 10 FD&C red no. 40 FD&C yellow no. 6 aluminum oxide ferrosoferric oxide magnesium stearate polyethylene glycols polyvinyl alcohol potassium sorbate powdered cellulose propylene glycol shellac sodium benzoate sodium citrate sucralose talc titanium dioxide sodium starch glycolate type A potato Tylenol;Eztab" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 8 tablets in 24 hours do not use for more than 10 days unless directed by a doctor children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 10 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." ], "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 allergic to acetaminophen or any of the inactive ingredients in this product" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-422-10 See New Warnings Information TYLENOL ® Pain Reliever Fever Reducer Acetaminophen EXTRA STRENGTH 100 TABLETS 500 mg each EASY TO SWALLOW EZ TABS WITH SWEET COATING PRINCIPAL DISPLAY PANEL" ] }, { "effective_time": "20121204", "inactive_ingredient": [ "INACTIVE INGREDIENTS alcohol, anhydrous citric acid, artificial & natural flavors, FD&C red no. 40, glycerin, high fructose corn syrup, liquid glucose, menthol, purified water, saccharin sodium, sodium benzoate" ], "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 a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic such as occurs with smoking, asthma, 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 LONG-ACTING dextromethorphan HBr DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP RACEMENTHOL WATER SACCHARIN SODIUM SODIUM BENZOATE dark red-colored syrup mentholated cherry-vanilla flavor and odor" ], "ask_doctor": [ "Ask a doctor before use if you have a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than 4 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose children under 12 years do not use adults and children 12 years and over 2 teaspoons every 6 to 8 hours" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS" ], "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 store at 20-25°C (68-77°F) dosage cup provided" ], "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 LONG-ACTING DEXTROMETHORPHAN HBr (Cough Suppressant) NON-DROWSY RELIEVES: Cough: Up to 8 Hours For Ages 12 & Over Alcohol 1.4% 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 LONG-ACTING Packaging" ], "indications_and_usage": [ "USE temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold" ], "set_id": "8366189d-f0ec-2128-cef0-93ef374a80a1", "id": "99a94723-ed1e-4c33-a4b0-205b97b1f71c", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH 5 ML TSP) Dextromethorphan HBr, USP 15 mg" ], "dosage_and_administration_table": [ "
age dose
children under 12 years do not use
adults and children 12 years and over 2 teaspoons every 6 to 8 hours
" ] }, { "effective_time": "20100716", "purpose": [ "Active ingredients (in each tablet) Purposes Aspirin 500 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine bitartrate 7.8 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 exceed recommended dosage may cause marked drowsiness 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 or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.com" ], "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 the unborn child or complications during delivery." ], "storage_and_handling": [ "Other information each tablet contains: sodium 474 mg Phenylketonurics: Contains Phenylalanine 5.6 mg per tablet store at room temperature. Avoid excessive heat." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains sinus congestion and pressure sore throat headache cough nasal congestion runny nose sneezing temporarily reduces fever" ], "set_id": "836c1bf4-7aec-4541-94ee-921659192cb3", "id": "297274bc-2bce-44ae-ad25-291ab2b9bbe9", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each tablet) Purposes Aspirin 500 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine bitartrate 7.8 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate" ], "warnings": [ "Warnings Reye's syndrome Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Alcohol warning If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding. 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 to sedate children. Do not use if you are allergic to aspirin or any other pain reliever/fever reducer 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. in children under 12 years of age Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems ulcers asthma heart disease high blood pressure diabetes thyroid disease glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis taking sedatives or tranquilizers When using this product do not exceed recommended dosage may cause marked drowsiness 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 an allergic reaction occurs. Seek medical help right away. pain, cough, or nasal congestion 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs 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 the unborn child or complications during delivery. 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": [ "Alka-Seltzer Plus Night Cold Medicine Aspirin, Doxylamine succinate, Phenylephrine bitartrate, and Dextromethorphan hydrobromide Aspirin Aspirin Doxylamine succinate Doxylamine Phenylephrine bitartrate Phenylephrine Dextromethorphan hydrobromide Dextromethorphan A;S;NT" ], "ask_doctor": [ "Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems ulcers asthma heart disease high blood pressure diabetes thyroid disease glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, or nasal congestion 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs" ], "do_not_use": [ "Do not use to sedate children.", "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer 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. in children under 12 years of age" ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Shipper Label ALKA-SELTZER PLUS ® NIGHT COLD FORMULA 3200 TABLETS 1600 PIECES SHIPPER CODE 1 00 16500 54213 8 MADE IN MEXICO PRODUCT CODE 82411594 STORE AT ROOM TEMPERATURE. AVOID EXCESSIVE HEAT Bayer HealthCare LLC Consumer Care P.O. Box 1910, Morristown, NJ 07962-1910 USA Principal Display Panel – Shipper Label" ], "purpose_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Smart Sense pain relief infants Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel Compare to the active ingredient of Concentrated Tylenol® Infants’ Drops INFANTS' PAIN RELIEF SEE NEW WARNINGS INFORMATION Concentrated Drops Acetaminophen Pain Reliever-Fever Reducer Aspirin Free Ibuprofen Free Alcohol Free GLUTEN FREE Grape FLAVOR 80mg per 0.8 mL Use only with enclosed dropper Pain Relief Carton Image 1 Pain Relief Carton Image 2 Pain Relief Carton Image 1 Pain Relief Carton Image 2" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "83fba880-18a5-46e6-8ea4-5b98a94d3d73", "id": "3c6fe1f7-1754-4543-8190-6cf3bb410aab", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20150817", "inactive_ingredient": [ "Inactive ingredients acrylates copolymer, aloe barbadensis leaf juice, aluminum powder, anhydrous citric acid, butylene glycol, charcoal powder, cocamidopropyl betaine, diazolidinyl urea, edetate disodium, ethylhexyl palmitate, fragrance, glycerin, menthol, methylparaben, PEG-8/SMDI copolymer, petrolatum, polyethylene, portulaca oleracea extract, potassium C-12-13 alkyl phosphate, propylparaben, purified water, silica, sodium C14-16 olefin sulfonate, trolamine" ], "purpose": [ "Purpose Salicylic acid - Acne treatment" ], "keep_out_of_reach_of_children": [ "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 When using this product • keep away from eyes. If contact occurs, flush thoroughly with water. • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product • keep away from eyes. If contact occurs, flush thoroughly with water. • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor." ], "questions": [ "Questions? Toll free 1-877-636-2677 MON-FRI 9 AM - 5 PM (EST)" ], "spl_product_data_elements": [ "OXY Purifying Face Scrub Maximum Salicylic Acid SALICYLIC ACID SALICYLIC ACID ALOE VERA LEAF ANHYDROUS CITRIC ACID BUTYLENE GLYCOL COCAMIDOPROPYL BETAINE DIAZOLIDINYL UREA EDETATE DISODIUM ETHYLHEXYL PALMITATE GLYCERIN MENTHOL METHYLPARABEN PETROLATUM PROPYLPARABEN WATER SILICON DIOXIDE SODIUM C14-16 OLEFIN SULFONATE TROLAMINE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • wet face • squeeze scrub into hands and massage gently over face and neck • rinse thoroughly" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel OXY purifying face scrub Acne Treatment 2% Salicylic Acid The Mentholatum Company, Orchard Park, NY 14127 OXY Purifying Face Scrub Maximum Acne Treatment 2% Salicylic Acid" ], "indications_and_usage": [ "Uses treats and helps prevent acne pimples" ], "set_id": "8475b379-0912-4843-9972-823e3ee710a1", "id": "731189dd-9fd6-4000-8b72-04996220c74a", "active_ingredient": [ "Active ingredient Salicylic acid 2%" ] }, { "effective_time": "20150417", "inactive_ingredient": [ "Inactive ingredients acrylates copolymer, anhydrous citric acid, C8-22 alkyl acrylates/methycrylic acid crosspolymer, disodium cocoamphodiacetate, edetate disodium, fragrance, methyl gluceth-20, PEG-7 glyceryl cocoate, PEG-8 dimethicone, potassium sorbate, purified water, sodium benzoate, sodium C14-16 olefin sulfonate, trolamine" ], "purpose": [ "Purpose Acne treatment" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children. If swallowed, contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only When using this product • keep away from eyes, lips and mouth. If contact occurs, flush thoroughly with water. • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time." ], "when_using": [ "When using this product • keep away from eyes, lips and mouth. If contact occurs, flush thoroughly with water. • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time." ], "questions": [ "Questions? Toll free 1-877-636-2677 MON - FRI 9 AM to 5 PM (EST)" ], "spl_product_data_elements": [ "OXY Clinical Foaming Face Wash Salicylic Acid SALICYLIC ACID SALICYLIC ACID ANHYDROUS CITRIC ACID DISODIUM COCOAMPHODIACETATE EDETATE DISODIUM METHYL GLUCETH-20 POTASSIUM SORBATE WATER SODIUM BENZOATE SODIUM C14-16 OLEFIN SULFONATE TROLAMINE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • wet face, pump product into hands and massage onto face • rinse well and pat dry • use twice daily • because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel OXY Clinical Foaming Face Wash Acne Treatment 2% Salicylic Acid OXY Clinical Foaming Face Wash", "Package/Label Principal Display Panel The Mentholatum Company Orchard Park NY, 14127 Active ingredient Salicylic acid 2%" ], "indications_and_usage": [ "Uses treats and help prevent acne blemishes" ], "set_id": "86ebd90c-9c7c-4d05-9ae4-f54246ef2d3d", "id": "def3e1e9-b543-4fec-a17c-ded1fa5cfb53", "active_ingredient": [ "Active ingredient Salicylic acid 2%" ] }, { "effective_time": "20120430", "purpose": [ "Purpose Antiemetic" ], "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)" ], "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" ], "questions": [ "Questions or comments? call 1-800-382-7219" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information Phenylketonurics: contains phenylalanine 0.84 mg per tablet store between 20–25°C (68–77°F) do not use if carton is opened or if blister unit is broken or torn see side panel for lot number and expiration date" ], "indications_and_usage": [ "Use for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness" ], "set_id": "88c564ee-3687-4c5c-8dd1-65857dec3621", "id": "f1dc68e5-01c4-456e-97f0-0776308a78a3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each tablet) Dimenhydrinate 50 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 to 2 chewable tablets every 4-6 hours do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years give ½ to 1 chewable tablet every 6-8 hours do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years give ½ chewable tablet every 6-8 hours do not give more than 1-1/2 chewable tablets in 24 hours, or as directed by a doctor
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol" ], "warnings": [ "Warnings Do not use for children under 2 years of age unless directed by a doctor Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are 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 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. (1-800-222-1222)" ], "spl_product_data_elements": [ "Dramamine Chewable Formula Dimenhydrinate Dimenhydrinate Dimenhydrinate anhydrous citric acid aspartame FD&C yellow no. 6 aluminum oxide magnesium stearate maltodextrin sorbitol Circular Flat Faced Tablet DRAMAMINE" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity to prevent or treat motion sickness, see below: adults and children 12 years and over take 1 to 2 chewable tablets every 4-6 hours do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor children 6 to under 12 years give ½ to 1 chewable tablet every 6-8 hours do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor children 2 to under 6 years give ½ chewable tablet every 6-8 hours do not give more than 1-1/2 chewable tablets in 24 hours, or as directed by a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "do_not_use": [ "Do not use for children under 2 years of age unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-310-08 Dimenhydrinate Tablets/Antiemetic Dramamine ® CHEWABLE FORMULA Convenient Chewable Tablets For Children and Adults. 8 ORANGE FLAVOR TABLETS (50 mg EACH) Principal Display Panel" ] }, { "effective_time": "20151209", "inactive_ingredient": [ "Acesulfame potassium, anhydrous citric acid, Aspartame, calcium phosphate dibasic, caramel, D and C yellow No. 10, flavors, Maltodextrin, silicon dioxide, Sodium Citrate, Starch, Sucrose." ], "purpose": [ "Uses - Temporarily relieves these symptoms due to a cold: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "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 6 packets 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. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include - skin reddening - blisters - rash. If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly." ], "spl_product_data_elements": [ "Well At Walgreens Multi-Symptom Severe Cold Green Tea and Honey Lemon flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID CALCIUM PHOSPHATE MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon flavor Natural Honey and Lemon Flavor Caramel color D and C Yellow No. 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "- do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet - dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough 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 - In a child under 4 years of age. - If you are allergic to acetaminophen. - with any other drug containing acetaminophen (prescription and 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 8 mg, sodium 15 mg, calcium 120 mg. - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage." ], "set_id": "8ae4d78c-835e-44e2-bd25-0e49595b0c40", "id": "267a19ca-b39e-05b8-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Multi-Symptom Severe Cold with Green Tea and Honey Lemon flavors Active ingredients (in each packet) Purpose Acetaminophen 500 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ] }, { "effective_time": "20130226", "inactive_ingredient": [ "Inactive Ingredients aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, cetyl alcohol, ethanol anhydrous, propylene glycol, purified water, sodium citrate, steareth-20, and stearyl alcohol, pressurized with a hydrocarbon (propane/isobutane/butane propellant)." ], "purpose": [ "Purpose Acne medication" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION." ], "warnings": [ "Warnings For external use only When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION." ], "when_using": [ "When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time." ], "questions": [ "Questions? call 1-888-784-3335 (1-888-STIEFEL). Side effects may be reported to this number." ], "spl_product_data_elements": [ "MaxClarity salicylic acid SALICYLIC ACID SALICYLIC ACID ALOE VERA LEAF ANHYDROUS CITRIC ACID BENZYL ALCOHOL CETYL ALCOHOL ALCOHOL PROPYLENE GLYCOL WATER SODIUM CITRATE STEARETH-20 STEARYL ALCOHOL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • Clean the area thoroughly before applying this product. • Shake can before use. • Invert can and then press firmly to dispense a small amount of foam (not more than a dollop the size of a golf ball). • Using fingers, cover the entire affected area with a thin layer 1 to 3 times daily. • Allow to dry. • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. • if bothersome dryness or peeling occurs, reduce application to once a day or every other day. Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above." ], "storage_and_handling": [ "Other information Store at 68° to 77°F (20° to 25°C). Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C)." ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0145-2841-02 MaxClarity ™ foam acne medication Rejuvenating Toner with VersaFoam ® Technology Salicylic Acid 0.5% Net Wt 2.64 Oz (75 g) MAXCLARITY is a trademark and VERSAFOAM is a registered trademark of Stiefel Laboratories, Inc. ©2011 Stiefel Laboratories www.maxclarity.com To reorder call 877-LIKE-MAX Stiefel Laboratories, Inc. Research Triangle Park, NC 27709 Made in Brazil DELIVERED IN VersaFoam ® HF HYDROETHANOLIC FORMULATION CFC FREE 10000000093322 MaxClarity Rejuvenating Toner label" ], "indications_and_usage": [ "Use For the treatment of acne" ], "set_id": "8b261540-8708-44d5-a297-d294e20a7e58", "id": "bb3dcb5a-0f22-48ec-93d8-5c91727d7a64", "active_ingredient": [ "Active ingredient Salicylic acid 0.5%" ] }, { "effective_time": "20121130", "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Chlorpheniramine maleate 2 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage excitability may occur, especially in children 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 or comments? call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if carton is opened or if blister unit is broken see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache sinus congestion and pressure nasal congestion runny nose and sneezing minor aches and pains temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus openings and passages" ], "set_id": "8b383ff8-ba2f-4201-ba5d-d84435917de7", "id": "207f71b8-6bf6-4374-ac87-94ef02f415af", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Chlorpheniramine maleate 2 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew or dissolve do not take more than 12 caplets in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, carnauba wax, colloidal silicon dioxide may contain one or more of these ingredients , corn starch, flavors, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium citrate, sodium starch glycolate, stearic acid , sucralose, titanium dioxide, yellow iron oxide" ], "warnings": [ "Warnings Alcohol warning If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage. Do not use with any other product containing acetaminophen 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 trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children 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 nervousness, dizziness, or sleeplessness occur pain or nasal congestion 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 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. (1-800-222-1222) 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": [ "Tylenol Allergy Multi-Symptom Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride Acetaminophen acetaminophen Chlorpheniramine Maleate Chlorpheniramine Phenylephrine Hydrochloride phenylephrine anhydrous citric acid carnauba wax silicon dioxide starch, corn hypromelloses ferrosoferric oxide magnesium stearate cellulose, microcrystalline polyethylene glycols polysorbate 80 potassium sorbate powdered cellulose propylene glycol shellac sodium benzoate sodium citrate sodium starch glycolate type a potato stearic acid sucralose titanium dioxide ferric oxide yellow Off white TY;Allergy;MS" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion 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 These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other product containing acetaminophen 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 caplet) Purpose
Acetaminophen 325 mg Pain reliever
Chlorpheniramine maleate 2 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-273-24 TYLENOL ® ALLERGY MULTI-SYMPTOM Pain Reliever, Nasal Decongestant, Antihistamine CONTAINS 3 MEDICINES: Headache – Acetaminophen Sinus Pressure Nasal Congestion Phenylephrine HCl Runny Nose/Sneezing Itchy, Watery Eyes Chlorpheniramine Maleate 24 Cool Burst™ CAPLETS PRINCIPAL DISPLAY PANEL" ], "purpose_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Chlorpheniramine maleate 2 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20100703", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C blue #1, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution" ], "purpose": [ "Purpose Cough suppressant *5 mL = one teaspoon" ], "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 Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has persistent or chronic cough such as occurs with asthma cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor if cough gets worse or lasts more than 7 days cough tends to come back or occurs with fever, rash, or headache that lasts These could be signs of a serious condition. 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)" ], "questions": [ "Questions or comments? call 1-888-474-3099" ], "spl_product_data_elements": [ "PediaCare LongActing Cough Dextromethorphan HBr DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if the child has persistent or chronic cough such as occurs with asthma cough accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions find right dose on chart below use only enclosed dosing cup designed for use with this product. if needed, repeat dose every 6 to 8 hours do not use more than 4 times in 24 hours Do not use any other dosing device. Age (yr) Does (tsp) Under 4 years Do not use 4 to 5 years one (1) teaspoonful 6 to 11 years two (2) teaspoonfuls Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "PediaCare Children’s Long-Acting Cough Drug Facts", "Other information each teaspoon contains: sodium 15 mg store between 20-25°C (68-77°F). Store in outer carton until contents are used. do not use if bottle wrap, or foil inner seal imprinted “Safety Seal®” is broken or missing see bottom panel for lot number and expiration date" ], "stop_use": [ "Stop use and ask a doctor if cough gets worse or lasts more than 7 days cough tends to come back or occurs with fever, rash, or headache that lasts These could be signs of a serious condition." ], "do_not_use": [ "Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product." ], "package_label_principal_display_panel": [ "Principal Display Panel See New Directions PediaCare Children’s Long-Acting Cough Dextromethorphan HBr oral solution Grape Flavor Liquid 4 FL OZ (118 mL ) Principal Display Panel PediaCare Children’s Long-Acting Cough 4 FL OZ (118 mL)" ], "indications_and_usage": [ "Use temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold" ], "set_id": "8e97133f-3ffc-4882-b545-0e60d06c4a10", "id": "e0a97b0d-9963-46cd-9df5-6ae8bce6af5b", "active_ingredient": [ "Active ingredient (in each 5 mL )* Dextromethorphan HBr 7.5 mg" ], "dosage_and_administration_table": [ "
Age (yr) Does (tsp)
Under 4 years Do not use
4 to 5 years one (1) teaspoonful
6 to 11 years two (2) teaspoonfuls
" ] }, { "effective_time": "20130717", "spl_unclassified_section_table": [ "
Important: Read all product information before using. Keep this box for important information. This product is intended for use in children.
" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "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)" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? Call 1-877-895-3665: weekdays 8:00 AM to 8:00 PM EST" ], "storage_and_handling": [ "Other information each teaspoon contains: sodium 2 mg store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted \"Safety Seal®\" is broken or missing see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever" ], "set_id": "92231ff4-7285-4a54-b97f-034c5c2f97a1", "id": "4084dfa3-1670-4f27-84a3-8c9de6875c83", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each 5 mL = 1 teaspoon) Ibuprofen 100 mg (NSAID) nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Dosing Chart
Weight (lb) Age (yr) Dose (tsp or mL)
under 2 years ask a doctor
24-35 lbs 2-3 years 1 tsp or 5 mL
36-47 lbs 4-5 years 1 ½ tsp or 7.5 mL
48-59 lbs 6-8 years 2 tsp or 10 mL
60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL
72-95 lbs 11 years 3 tsp or 15 mL
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, FD&C red #40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucralose, sucrose, xanthan gum" ], "warnings": [ "Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child: 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 Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear 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)" ], "spl_product_data_elements": [ "Childrens Motrin Ibuprofen Ibuprofen Ibuprofen acesulfame potassium anhydrous citric acid FD&C red NO. 40 glycerin polysorbate 80 water sodium benzoate sucralose sucrose xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed measuring cup if needed, repeat dose every 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (tsp or mL) under 2 years ask a doctor 24-35 lbs 2-3 years 1 tsp or 5 mL 36-47 lbs 4-5 years 1 ½ tsp or 7.5 mL 48-59 lbs 6-8 years 2 tsp or 10 mL 60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL 72-95 lbs 11 years 3 tsp or 15 mL" ], "spl_unclassified_section": [ "Important: Read all product information before using. Keep this box for important information. This product is intended for use in children.", "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL See New Warnings Information NDC 50580-215-04 For Ages 2 to 11 Children's Motrin ® contains Ibuprofen Oral Suspension (NSAID) 100 mg per 5 mL (teaspoon) Pain Reliever / Fever Reducer Lasts up to 8 hours Tropical Punch Flavor Alcohol Free 4 FL OZ (120 mL) Principal Display Panel" ] }, { "effective_time": "20121220", "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose Questions or comments? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675" ], "purpose": [ "PURPOSES Cough suppressant 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." ], "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 high blood pressure thyroid disease diabetes trouble urinating due to an 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 When using this product do not use 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 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" ], "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 COLD CF dextromethorphan HBr, guaifenesin, phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE clear red liquid berry-citrus flavor" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an 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" ], "openfda": {}, "version": "4", "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 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 3 mg store at 20-25°C (68-77°F) dosage cup provided" ], "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 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 & Cold CF DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) PHENYLEPHRINE HCI (Nasal Decongestant) NON-DROWSY RELIEVES: Cough Stuffy Nose Chest Congestion/Mucus NEW IMPROVED TASTE 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 USA © 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 & Cold CF Packaging" ], "indications_and_usage": [ "USES helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation" ], "set_id": "92cd8667-2d65-905a-6b86-8ea825031c58", "id": "9645cd68-0f73-4a0d-832c-4d57d1d871cb", "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH 5ML TSP) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 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": "20121218", "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 CHEST CONGESTION GUAIFENESIN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID CARAMEL FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP DEXTROSE MENTHOL PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE deep wine-colored syrupy liquid raspberry flavor" ], "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 this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2-4 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 2 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." ], "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 Chest Congestion GUAIFENESIN, USP (Expectorant) NON-DROWSY RELIEVES: Chest Congestion/Mucus 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 Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. Robitussin Chest Congestion Packaging" ], "indications_and_usage": [ "USE helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive" ], "set_id": "931539cf-9c49-700d-78f7-89046ef666cd", "id": "05c29eaf-5c8e-4688-8d24-37df93b50a71", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH 5 ML TSP) Guaifenesin, USP 100 mg" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over 2-4 teaspoons every 4 hours
children under 12 years do not use
" ] }, { "effective_time": "20120409", "purpose": [ "Purpose Fever reducer/pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other Information store between 20-25°C (68-77°F) tamper evident statement see bottom panel of carton for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache" ], "set_id": "94b97961-73ca-4a9f-9da2-b38dca7cb4dc", "id": "ee066a8f-fe0b-4f19-824b-c2de4b368c88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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 anhydrous citric acid, butylparaben, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sorbitol solution, sucralose, xanthan gum" ], "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. 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 this product do not exceed recommended dose (see overdose warning ) 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Infants Concentrated TYLENOL Acetaminophen Acetaminophen Acetaminophen anhydrous citric acid butylparaben glycerin cellulose, microcrystalline carboxymethylcellulose sodium propylene glycol propylparaben water sorbitol sucralose xanthan gum white to off-white" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "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 ) shake well before using 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 if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor replace dropper tightly to maintain child resistance Dosing Chart 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) Attention use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "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." ], "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 See New Warnings Information NDC 50580-167-01 Concentrated TYLENOL ® Infants' Drops Acetaminophen Fever Reducer, Pain Reliever INFANTS Pediatricians' 1st Choice Alcohol Free Aspirin Free Ibuprofen Free Dye Free NON-STAINING FORMULA Cherry FLAVOR 1 FL OZ (30mL) 80mg per 0.8mL USE ONLY Enclosed Dropper PRINCIPAL DISPLAY PANEL" ] }, { "effective_time": "20120910", "purpose": [ "Purpose Pain reliever/fever reducer" ], "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)" ], "when_using": [ "When using this product mouth or throat burning may occur; give with food or water take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? Call 1-877-895-3665: weekdays 8:00 AM to 8:00 PM EST" ], "storage_and_handling": [ "Other information phenylketonurics: contains phenylalanine 2.8 mg per tablet store between 20-25°C (68-77°F) do not use if neck wrap or foil inner seal imprinted \"Safety Seal®\" is broken or missing see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches" ], "set_id": "96d674d8-c4d2-49a4-b372-95a7f4ffe9ea", "id": "2073e5a2-1419-4bfe-b888-866a82703e6a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 100 mg (NSAID) nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Dosing Chart
Weight (lb) Age (yr) Tablets
under 24 under 2 ask a doctor
24 - 35 2 - 3 1
36 - 47 4 - 5 1 1/2
48 - 59 6 - 8 2
60 - 71 9 - 10 2 1/2
72 - 95 11 3
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, D&C red #7 calcium lake, D&C red #30 aluminum lake, FD&C blue #1 aluminum lake, flavor, fumaric acid, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate" ], "warnings": [ "Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child: 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 Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product mouth or throat burning may occur; give with food or water take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if child experience any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear 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)" ], "spl_product_data_elements": [ "Motrin Junior Strength Ibuprofen Ibuprofen ibuprofen acesulfame potassium anhydrous citric acid aspartame D&C red no. 30 FD&C blue no. 1 aluminum oxide fumaric acid hypromelloses magnesium stearate mannitol cellulose, microcrystalline povidones sodium lauryl sulfate Sodium Starch Glycolate Type A Potato MO;100" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic" ], "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 find right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24 - 35 2 - 3 1 36 - 47 4 - 5 1 1/2 48 - 59 6 - 8 2 60 - 71 9 - 10 2 1/2 72 - 95 11 3" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if child experience any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL See New Warnings Information NDC 50580-909-24 Motrin ® Junior Strength For Ages 2 to 11 Lasts up to 8 hours contains Ibuprofen Tablets (NSAID), 100 mg Pain Reliever / Fever Reducer 24 Grape-Flavored Chewable Tablets PRINCIPAL DISPLAY PANEL" ] }, { "effective_time": "20130904", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, corn syrup, D&C red #33, FD&C red #40, FD&C yellow #6, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "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 Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the child: • has had stomach ulcers or bleeding problems • takes a blood thinning (anticoagulant) or steroid drug • takes other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others) • takes more or for a longer time than directed Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use • if the child has ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if the child has • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain • ulcers • bleeding problems • not been drinking fluids • lost a lot of fluid due to vomiting or diarrhea • high blood pressure • heart or kidney disease • taken a diuretic Ask a doctor or pharmacist before use if the child is • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug • under a doctor’s care for any serious condition • taking any other drug When using this product • give with food or milk if stomach upset occurs • long term continuous use may increase the risk of heart attack or stroke Stop use and ask a doctor if • the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. • stomach pain or upset gets worse or lasts • the child does not get any relief within first day (24 hours) of treatment • fever or pain gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear 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 • give with food or milk if stomach upset occurs • long term continuous use may increase the risk of heart attack or stroke" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Leader Childrens Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS CITRIC ACID BUTYLPARABEN D&C RED NO. 33 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN HYPROMELLOSES POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL CORN SYRUP XANTHAN GUM opaque" ], "ask_doctor": [ "Ask a doctor before use if the child has • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain • ulcers • bleeding problems • not been drinking fluids • lost a lot of fluid due to vomiting or diarrhea • high blood pressure • heart or kidney disease • taken a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed • do not give longer than 10 days, unless directed by a doctor (see Warnings) • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise use age. • use only with enclosed measuring cup • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day • replace original bottle cap to maintain child resistance • wash dosage cup after each use Dosing Chart Weight (lb) Age(yrs) Dose (teaspoonful or mL) under 2 years ask a doctor 24-35 lbs 2-3 years 1 tsp or 5 mL 36-47 lbs 4-5 years 1 ½ tsp or 7.5 mL 48-59 lbs 6-8 years 2 tsp or 10 mL 60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL 72-95 lbs 11 years 3 tsp or 15 mL" ], "stop_use": [ "Stop use and ask a doctor if • the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. • stomach pain or upset gets worse or lasts • the child does not get any relief within first day (24 hours) of treatment • fever or pain gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear" ], "storage_and_handling": [ "Other information • do not use if printed neckband is broken or missing • store at 20-25°C (68-77°F) • see bottom panel for lot number and expiration date" ], "do_not_use": [ "Do not use • if the child has ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel For Ages 2 - 11 Children’s Ibuprofen Oral Suspension 100 mg per 5 mL (teaspoonful) Pain Reliever Fever Reducer (NSAID) Lasts up to 8 Hours Fruit Flavor Alcohol Free Children's Ibuprofen Oral Suspension Carton Children's Ibuprofen Oral Suspension Carton" ], "indications_and_usage": [ "Uses temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever" ], "set_id": "97fb93c3-a4da-4335-9ebe-021299598e21", "id": "a19ce1c2-65ab-465c-9b62-52fa4c20b59c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug • under a doctor’s care for any serious condition • taking any other drug" ], "active_ingredient": [ "Active ingredient (in each 5 mL = 1 teaspoonful) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Dosing Chart
Weight (lb) Age(yrs) Dose (teaspoonful or mL)
under 2 years ask a doctor
24-35 lbs 2-3 years 1 tsp or 5 mL
36-47 lbs 4-5 years 1 ½ tsp or 7.5 mL
48-59 lbs 6-8 years 2 tsp or 10 mL
60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL
72-95 lbs 11 years 3 tsp or 15 mL
" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions? Call 1-800-910-6874" ], "spl_product_data_elements": [ "Up and Up infants acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel Infants' Acetaminophen Concentrated Drops 80 mg per 0.8 mL Fever Reducer/Pain Reliever Compare to active ingredient in Concentrated Tylenol® Infants’ Drops See New Warnings Information Use only with enclosed dropper Grape Flavor Age 2-3 Years Infants' Acetaminophen Carton Infants' Acetaminophen Carton" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "9ab25460-333b-4d6f-9244-64d6266a0365", "id": "0eff5c55-a233-4460-afc8-bdd630d63a78", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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": "20150814", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylene glycol, cocamidopropyl betaine, diazolidinyl urea, fragrance, hydroylzed soy protein, hydoxyphenyl propamidobenzoic acid, methylparaben, pentylene glycol, propylparaben, purified water, sodium citrate, sodium cocoyl isethionate, sodium lauroyl sarcosinate, xanthan gum" ], "purpose": [ "Purpose Benzoyl peroxide - Acne treatment" ], "keep_out_of_reach_of_children": [ "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 Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor if if irritation becomes severe and continues" ], "when_using": [ "When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration." ], "spl_product_data_elements": [ "Oxy Face Wash Mild Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE ANHYDROUS CITRIC ACID BUTYLENE GLYCOL COCAMIDOPROPYL BETAINE DIAZOLIDINYL UREA HYDROXYPHENYL PROPAMIDOBENZOIC ACID METHYLPARABEN PENTYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SODIUM COCOYL ISETHIONATE SODIUM LAUROYL SARCOSINATE XANTHAN GUM" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • wet face • apply to hands, add water, work into a lather, and massage gently onto face • rinse thoroughly and pat dry • if bothersome dryness or peeling occurs, reduce application to once a day or every other day • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and 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 if irritation becomes severe and continues" ], "do_not_use": [ "Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel OXY face wash 5% Benzoyl Peroxide", "Package/Label Principal Display Panel Drug Facts" ], "indications_and_usage": [ "Uses treats and helps prevent acne pimples" ], "set_id": "9c801504-5cc7-47e8-b40b-c2e0604664bc", "id": "666a51b6-5c4c-4bee-b62a-29697d73d41e", "active_ingredient": [ "Active ingredient Benzoyl peroxide 5%" ] }, { "effective_time": "20131108", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F). Avoid high humidity. Protect from light. do not use if carton or blister unit is opened or broken see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: the common cold flu headache sore throat temporarily reduces fever" ], "set_id": "9dd13375-d202-4d84-883c-e688a4e82093", "id": "daf9e8a3-5cbe-467d-a10c-72cd9c606a7c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 160 mg" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tablets) or as directed by a doctor
under 48 under 6 years ask a doctor
48-59 6-8 years 2 tablets
60-71 9-10 years 2½ tablets
72-95 11 years 3 tablets
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose excipient, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose" ], "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. 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 this product do not exceed recommended dose (see overdose warning ) 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Jr TYLENOL Acetaminophen Acetaminophen Acetaminophen anhydrous citric acid cellulose acetate crospovidone D&C red no. 7 D&C red no. 30 FD&C blue no. 1 aluminum oxide magnesium stearate povidones sucralose TY;160" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "3", "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 below. If possible, use weight to dose; otherwise, use age. chew before swallowing; this product will soften in mouth for ease of chewing repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets) or as directed by a doctor under 48 under 6 years ask a doctor 48-59 6-8 years 2 tablets 60-71 9-10 years 2½ tablets 72-95 11 years 3 tablets" ], "spl_unclassified_section": [ "Drug Facts" ], "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." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-514-24 Jr. TYLENOL ® Acetaminophen Pain Reliever-Fever Reducer For Children AGES 6-11 ∙ MEDICINE PER TABLET ∙ 160 mg Meltaways ™ 24 Chewable Tablets Aspirin Free ∙ Ibuprofen Free Grape Punch flavor PRINCIPAL DISPLAY PANEL" ] }, { "effective_time": "20121207", "inactive_ingredient": [ "INACTIVE INGREDIENTS Robitussin Cough & Chest Congestion DM anhydrous citric acid, FD&C red no. 40, glycerin, high fructose corn syrup, menthol, natural flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose Robitussin Cough & Chest Congestion Sugar Free DM acesulfame potassium, artificial & natural flavor, citric acid monohydrate, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate", "Robitussin Cough & Chest Congestion DM anhydrous citric acid, FD&C red no. 40, glycerin, high fructose corn syrup, menthol, natural flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose", "Robitussin Cough & Chest Congestion Sugar Free DM acesulfame potassium, artificial & natural flavor, citric acid monohydrate, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate" ], "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 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP MENTHOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SUCRALOSE Clear red liquid pineapple orange flavor and odor ROBITUSSIN COUGH AND CHEST CONGESTION SUGAR FREE DM DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ACESULFAME POTASSIUM CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN POVIDONES PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE Clear, colorless to slightly yellow 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 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 Robitussin Cough & Chest Congestion DM each teaspoon contains: sodium 7 mg store at 20-25°C (68-77°F) dosage cup provided Robitussin Cough & Chest Congestion Sugar Free DM each teaspoon contains: sodium 4 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 DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) NON-DROWSY RELIEVES: Cough Chest Congestion/Mucus NEW IMPROVED TASTE For Ages 12 & Over Alcohol-Free 8 FL OZ (237 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 USA © 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 Packaging", "See New Dosing Information Adult Robitussin Cough & Chest Congestion Sugar Free DM DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) NON-DROWSY RELIEVES: Cough Chest Congestion/Mucus Specially Formulated for DIABETICS For Ages 12 & Over Alcohol & Sugar-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 Sugar-Free DM 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": "9e2fbc19-46bd-b683-579b-cdc001f28361", "id": "2f9fad00-0024-4161-8bd0-ab7414529a23", "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH 5 ML TSP) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 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": "20121002", "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 1. do not exceed recommended dosage 2. may cause marked drowsiness 3. avoid alcoholic drinks 4. excitability may occur, especially in children 5. alcohol, sedatives and tranquilizers may increase drowsiness 6. be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-855-874-0970" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves the following cold/flu symptoms: 1. headache 2. cough 3. temporarily reduces fever 4. sore throat 5. runny nose and sneezing 6. minor aches and pains" ], "set_id": "9e440092-0995-11e2-892e-0800200c9a66", "id": "6e225d51-fa19-4a6e-884e-7e41c4624e53", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking 1. the blood thinning drug warfarin 2. sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each 15 mL = 1 tablespoon) Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "dosage_and_administration_table": [ "take 2 tablespoons (TBSP) in dose cup provided every 6 hoursdo not use this adult product in children under 12 years of age
adults & children 12 years and older
1.
children under 12 years
1.
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue #1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: 1. more than 6 tablespoons in 24 hours, which is the maximum daily amount 2. with other drugs containing acetaminophen 3. 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." ], "spl_product_data_elements": [ "Contac Cold and Flu Cooling Relief acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM FD&C BLUE NO. 1 POLYETHYLENE GLYCOLS PROPYLENE GLYCOL SODIUM BENZOATE SORBITOL SUCROSE WATER" ], "ask_doctor": [ "Ask a doctor before use if you have 1. liver disease 2. glaucoma 3. cough that occurs with too much phlegm (mucus) 4. trouble urinating due to an enlarged prostate gland 5. a breathing problem such as emphysema or chronic bronchitis 6. persistent or chronic cough such as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions 1. do not take more than directed ( see Liver warning ) 2. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults & children 12 years and older 1. take 2 tablespoons (TBSP) in dose cup provided every 6 hours children under 12 years 1. do not use this adult product in children under 12 years of age" ], "stop_use": [ "Stop use and ask a doctor if 1. pain or cough gets worse or lasts more than 7 days 2. fever gets worse or lasts more than 3 days 3. redness or swelling is present 4. new symptoms occur 5. cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition." ], "spl_unclassified_section": [ "Other information 1. each tablespoon contains: potassium 25 mg and sodium 8 mg 2. store between 20°-25°C (68°-77°F). Do not refrigerate.", "Manufactured for: Meda Consumer Healthcare Inc. Marietta, GA 30062 Made in the U.S.A. Contac ® is a registered trademark of Meda AB © 2012 Meda AB www.contac.com" ], "do_not_use": [ "Do not use 1. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 2. if you are now taking a 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. 3. if you have ever had an allergic reaction to this product or any of its ingredients 4. to make a child sleepy" ], "package_label_principal_display_panel": [ "Display Panel Contac Cooling Relief: INSTANT COOLING RELIEF NIGHT CONTAC ® COLD+FLU Acetaminophen, Dextromethorphan, Doxylamine Maximum Strength Multi-Symptom Sore Throat + Head & Body Aches + Fever Cough + Runny Nose & Sneezing 8 FL OZ DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING Manufactured for: Meda Consumer Healthcare Inc. Marietta, GA 30062 Made in the U.S.A. CONTAC ® is a registered trademark of Meda AB. © 2012 Meda AB www.contac.com", "CONTAC Cooling Relief 8 FL OZ Bottle Label", "CONTAC Cooling Relief Drug Facts Label", "CONTAC Cooling Relief Drug Facts Label Continued" ], "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20120202", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD and C red #40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "purpose": [ "Purpose 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. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever 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)" ], "when_using": [ "When using this product do not exceed recommended dose" ], "questions": [ "Questions or comments? call 1-888-217-2117" ], "spl_product_data_elements": [ "Non-Drowsy Childrens Sudafed PE Nasal Decongestant Phenylephrine HCl Solution PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE" ], "ask_doctor": [ "Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet" ], "other_safety_information": [ "Other information each 5 mL (1 tsp) contains: sodium 14 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used. do not use if bottle wrap, or foil inner seal imprinted \"Safety Seal®\" is broken or missing see bottom panel for lot number and expiration date" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions find right dose on chart below mL = milliliter; tsp = teaspoonful repeat dose every 4 hours do not use more than 6 times in 24 hours Age (yr) Dose (mL or tsp) under 4 years do not use 4 to 5 years 5 mL (1 tsp) 6 to 11 years 10 mL (2 tsp) Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever" ], "do_not_use": [ "Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product." ], "package_label_principal_display_panel": [ "NDC 50580-784-04 NON-DROWSY children's SUDAFED PE® NASAL DECONGESTANT Phenylephrine HCl oral solution Nasal decongestant Sinus Pressure and Stuffy Nose Phenylephrine HCl Due to Colds and Allergies Raspberry Flavor Liquid Alcohol and Sugar Free 4 fl oz (118 ml) 2.5 mg per 5 ml Label for Sudafed PE Raspberry - front Label for Sudafed PE Raspberry - back" ], "indications_and_usage": [ "Use temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies" ], "set_id": "9e489488-211a-4085-9cad-2596f7ca1d94", "id": "398e014d-536c-413d-a502-f56076ab8d3c", "active_ingredient": [ "Active ingredient (in each 5 mL = 1 teaspoonful) Phenylephrine HCl 2.5 mg" ], "dosage_and_administration_table": [ "
Age (yr) Dose (mL or tsp)
under 4 years do not use
4 to 5 years 5 mL (1 tsp)
6 to 11 years 10 mL (2 tsp)
" ] }, { "effective_time": "20151110", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "storage_and_handling": [ "Other information each 5 mL (1 tsp) contains: sodium 2 mg store between 20-25°C (68-77°F) do not use if neck wrap or foil inner seal imprinted with \"SAFETY SEAL®\" is broken or missing see top panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache" ], "set_id": "a3820e30-4ab1-4bdc-bbda-2881581b37d8", "id": "e0828441-ebb8-4173-94e6-e4f639461ec8", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (mL or tsp)or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL (1 tsp)
36-47 4-5 years 7.5 mL (1½ tsp)
48-59 6-8 years 10 mL (2 tsp)
60-71 9-10 years 12.5 mL (2½ tsp)
72-95 11 years 15 mL (3 tsp)
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum" ], "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. 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 this product do not exceed recommended dose (see overdose warning ) 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. 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens Tylenol acetaminophen acetaminophen acetaminophen anhydrous citric acid butylparaben D&C red NO. 33 FD&C blue NO. 1 glycerin high fructose corn syrup cellulose, microcrystalline carboxymethylcellulose sodium, unspecified form propylene glycol water sodium benzoate sorbitol xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "5", "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 ) shake well before using mL = milliliter; tsp = teaspoonful find right dose on chart below. If possible, use weight to dose; otherwise, use age. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL or tsp) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL (1 tsp) 36-47 4-5 years 7.5 mL (1½ tsp) 48-59 6-8 years 10 mL (2 tsp) 60-71 9-10 years 12.5 mL (2½ tsp) 72-95 11 years 15 mL (3 tsp) Attention : use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "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." ], "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 See New Warnings Information NDC 50580-318-10 Children's TYLENOL ® Acetaminophen Oral Suspension Pain Reliever, Fever Reducer AGES 2-11 Pediatricians' 1st Choice Alcohol Free Aspirin Free Ibuprofen Free grape FLAVOR 3.38 fl oz (100ml) 80 mg per ½ teaspoon (160 mg per 5 ml) PRINCIPAL DISPLAY PANEL" ] }, { "effective_time": "20130926", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant 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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms ." ], "when_using": [ "When using this product • 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 or comments? 1-800-719-9260" ], "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 39 mg • store at 20°-25°C (68°-77°F)" ], "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": "a3af087e-77e5-44d6-be20-64b8201ad259", "id": "9cdda378-de9f-4bb6-9a6c-ccff44fff912", "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 & children 12 yrs & 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, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate Questions or comments? 1-800-719-9260" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 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, consult a doctor promptly." ], "spl_product_data_elements": [ "Smart Sense NightTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 ALCOHOL POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE HIGH FRUCTOSE CORN SYRUP clear dark red berry/fruity" ], "ask_doctor": [ "Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough as occurs with smoking, asthma, or emphysema • a sodium-restricted diet" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • take only as directed – see Liver warning • use dose cup • do not exceed 4 doses per 24 hrs adults & children 12 yrs & 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 Daytime or Nighttime products, carefully read each label to insure correct dosing" ], "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 sleepy • if you have ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Compare to the active ingredients of Vicks® NyQuil® Cold & Flu Multi-Symptom COLD & FLU NightTime Acetaminophen – Aches, Fever, Sore Throat Dextromethorphan HBr – Cough Doxylamine Succinate – Sneezing, Runny Nose Pain Reliever – Fever Reducer, Cough Suppressant – Antihistamine NIGHTTIME RELIEF Mixed Berry Flavor ALCOHOL 10% 12 FL OZ (354 mL) Smart Sense NightTime Cold & Flu.jpg" ] }, { "effective_time": "20100630", "spl_unclassified_section_table": [ "
age dose
adults and children 12 years and over 2 teaspoons every 4 hours
children under 12 years do not use
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "purpose": [ "PURPOSES Cough suppressant 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." ], "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 high blood pressure thyroid disease diabetes trouble urinating due to an 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 When using this product do not use 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 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" ], "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 COLD D dextromethorphan HBr, guaifenesin, pseudoephedrine HCl dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin pseudoephedrine hydrochloride pseudoephedrine" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an 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" ], "openfda": {}, "version": "2", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "DIRECTIONS do not take more than 4 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 Other information each teaspoon contains : sodium 4 mg store at 20-25°C (68-77°F) dosage cup provided" ], "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 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 Labeling Information Adult Robitussin Cough & Cold D DEXTRMETHORPHAN HBr, Cough Suppressant GUAIFENESIN, Expectorant PSEUDOEPHEDRINE HCl, Nasal Decongestant NON-DROWSY RELIEVES: Cough Chest Congestion/Mucus Stuffy Nose For Ages 12 & Over 8 FL OZ (237 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 Patent Pending 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. PAA008254.jpg" ], "indications_and_usage": [ "USES helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation" ], "set_id": "a662637c-2349-8774-993f-aee9e994c2b3", "id": "02d69d25-9a0e-8ce0-e67e-a355a1e74404", "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH 5 ML TSP) Dextromethorphan HBr, USP 15 mg Guaifenesin, USP 200 mg Pseudoephedrine HCl, USP 30 mg" ] }, { "effective_time": "20121220", "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage." ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each caplet contains: sodium 3 mg store between 20 - 25°C (68 - 77°F) do not use if carton or pouch is opened or torn see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses for the temporary relief of: sinus congestion and pressure headache nasal congestion minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves nasal congestion due to the common cold, and hay fever and other upper respiratory allergies" ], "set_id": "a72736d9-f867-4d75-8142-5d5d78cae1b9", "id": "3b80c7be-3333-43e8-95c5-486819629099", "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 caplet) Purpose Acetaminophen 325 mg Pain reliever Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew or dissolve do not take more than 12 caplets in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, potassium sorbate, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium citrate, sucralose, titanium dioxide, triacetin" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets 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 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion 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 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Tylenol Sinus Congestion and Pain Severe Acetaminophen, Guaifenesin, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Guaifenesin Guaifenesin Phenylephrine hydrochloride Phenylephrine TY;Sinus;Severe" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts", "Repackaged and distributed by: Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402 1-877-507-6516 (M-F 8AM-4:30PM CST) www.lildrugstore.com" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain, nasal congestion 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. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Caplet Carton See New Warnings Information TYLENOL ® SINUS CONGESTION & PAIN SEVERE Alleviates Sinus Headache & Pain Acetaminophen Thins & Loosens Mucus Relieves Chest Congestion Guaifenesin Relieves Sinus Pressure Clears Nasal Congestion Phenylephrine HCl Cool Burst™ CAPLETS 6 CAPLETS Lil DrugStore ® Principal Display Panel - 6 Caplet Carton" ], "purpose_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20140619", "purpose": [ "Active ingredients (in each 20 mL) Delsym Cough+ Cold Day Time Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant", "Active ingredients (in each 20 mL) Delsym Cough+ Cold Night Time Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine HCl 25 mg Antihistamine/ cough suppressant Phenylephrine HCl 10 mg Nasal decongestant" ], "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 (Night Time only) marked drowsiness may occur (Night Time only) alcohol, sedatives, and tranquilizers may increase drowsiness (Night Time only) avoid alcoholic drinks ( Night Time only) be careful when driving a motor vehicle or operating machinery (Night Time only)" ], "questions": [ "Questions? 1-888-963-3382" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each 20 mL contains: sodium 12 mg do not refrigerate store between 20-25°C (68-77°F) dosing cup provided" ], "indications_and_usage": [ "Uses temporarily relieves these common cold and flu symptoms: nasal congestion cough minor aches and pains headache sore throat runny nose and sneezing (Night Time only) controls cough to help you get to sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Day Time only) temporarily reduces fever" ], "set_id": "a73eebb1-5773-4079-b234-5d39adc7e537", "id": "c0669e7c-ede9-4263-ace6-d43853d77cb2", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Night Time only)" ], "active_ingredient": [ "Active ingredients (in each 20 mL) Delsym Cough+ Cold Day Time Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant", "Active ingredients (in each 20 mL) Delsym Cough+ Cold Night Time Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine HCl 25 mg Antihistamine/ cough suppressant Phenylephrine HCl 10 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients (Delsym Cough+ Cold Day Time) anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient , xanthan gum", "Inactive ingredients (Delsym Cough+ Cold Night Time) anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate , xanthan gum" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses in 24 hours, which is the maximum daily amount with other drugs that contain 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. with any other drug containing diphenhydramine, even one used on the skin (Night Time only) 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 high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma (Night Time only) a breathing problem such as emphysema or chronic bronchitis (Night Time only) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Night Time only) When using this product do not use more than directed excitability may occur, especially in children (Night Time only) marked drowsiness may occur (Night Time only) alcohol, sedatives, and tranquilizers may increase drowsiness (Night Time only) avoid alcoholic drinks ( Night Time only) be careful when driving a motor vehicle or operating machinery (Night Time only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, 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 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. 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 Cough Plus Cold Day Time and Delsym Cough Plus Cold Night Time Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride Delsym Cough Plus Cold Day Time Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin Phenylephrine Hydrochloride Phenylephrine anhydrous citric acid edetate disodium FD&C Blue No. 1 FD&C Red No. 40 glycerin propylene glycol propyl gallate water sodium benzoate sorbitol sucralose trisodium citrate dihydrate xanthan gum Delsym Cough Plus Cold Night Time Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine anhydrous citric acid edetate disodium FD&C Blue No. 1 FD&C Red No. 40 glycerin propylene glycol propyl gallate water sodium benzoate sorbitol sucralose trisodium citrate dihydrate xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma (Night Time only) a breathing problem such as emphysema or chronic bronchitis (Night Time only) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see Overdose warning ) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided with product dose as follows or as directed by a doctor mL = milliliter adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, 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 fever, 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. with any other drug containing diphenhydramine, even one used on the skin (Night Time only) 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 20 mL) Delsym Cough+ Cold Day Time Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
", "
Active ingredients (in each 20 mL) Delsym Cough+ Cold Night Time Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine HCl 25 mg Antihistamine/ cough suppressant
Phenylephrine HCl 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Kit Carton NDC 63824-217-22 COMBO PACK Delsym ® COUGH+™COLD DAY TIME Acetaminophen (Pain Reliever/Fever Reducer) Dextromethorphan HBr (Cough Suppressant) Guaifenesin (Expectorant) Phenylephrine HCl (Nasal Decongestant) ✓ Cough ✓ Sore Throat ✓ Headache ✓ Nasal & Chest Congestion ✓ Fever NIGHT TIME Acetaminophen (Pain Reliever/Fever Reducer) Diphenhydramine HCl (Antihistamine/Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) ✓ Cough ✓ Sore Throat ✓ Fever ✓ Nasal Congestion ✓ Body Aches TWO – 6 fl oz (180 mL) bottles TOTAL – 12 fl oz (360 mL) For Ages 12+ Mixed Berry Flavored Liquid Principal Display Panel - Kit Carton" ], "purpose_table": [ "
Active ingredients (in each 20 mL) Delsym Cough+ Cold Day Time Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
", "
Active ingredients (in each 20 mL) Delsym Cough+ Cold Night Time Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine HCl 25 mg Antihistamine/ cough suppressant
Phenylephrine HCl 10 mg Nasal decongestant
" ], "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 for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20150814", "inactive_ingredient": [ "Inactive ingredients aloe barbadensis leaf extract, anhydrous citric acid, cetyl alcohol, diazodinyl urea, glycerin, glyceryl stearate, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, trolamine" ], "purpose": [ "Purpose Topical analgesic" ], "keep_out_of_reach_of_children": [ "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 Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product • use only as directed • do not get into eyes or on mucous membranes • do not apply to wounds or damaged skin • do not bandage tightly • do not use with a heating pad or apply external heat Stop use and ask a doctor if • condition worsens • redness is present • excessive irritation of the skin develops • pain persists for more than 7 days • symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use." ], "when_using": [ "When using this product • use only as directed • do not get into eyes or on mucous membranes • do not apply to wounds or damaged skin • do not bandage tightly • do not use with a heating pad or apply external heat" ], "questions": [ "Questions? Call 1-800-910-6874" ], "spl_product_data_elements": [ "up and up pain relief odorless Trolamine salicylate TROLAMINE SALICYLATE SALICYLIC ACID ALOE VERA LEAF ANHYDROUS CITRIC ACID CETYL ALCOHOL DIAZOLIDINYL UREA GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN MINERAL OIL PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE STEARIC ACID TROLAMINE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • adults and children 12 years and over: apply generously to affected area, and massage until thoroughly absorbed into skin • apply not more than 4 times daily • children under 12 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 • condition worsens • redness is present • excessive irritation of the skin develops • pain persists for more than 7 days • symptoms clear up and occur again within a few days" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel up and up pain-relief cream odorless trolamine salicylate 10% up and up pain-relief cream odorless trolamine salicylate 10%" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains of muscles and joints due to • arthritis • sprains • simple backache • bruises • strains • cramps" ], "set_id": "a8107155-e901-414b-beb5-1aa65f2e8739", "id": "138521ae-7217-447d-aee3-884c34afdd71", "active_ingredient": [ "Active ingredient Trolamine salicylate 10%" ] }, { "effective_time": "20151125", "purpose": [ "Active ingredients (in each 15 mL = 1 tablespoon) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose" ], "questions": [ "Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each 15 mL (1 TBSP) (½ FL OZ) contains: sodium 5 mg store between 20-25°C (68-77°F). Do not refrigerate. do not use if plastic neck wrap or foil inner seal imprinted with \"SAFETY SEAL®\" is broken or missing" ], "indications_and_usage": [ "Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages promotes nasal and sinus drainage temporarily reduces fever" ], "set_id": "a87323dd-3249-458c-9650-cc88fed36a79", "id": "7370fc2c-db90-47ce-ade1-3fcff411da77", "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 = 1 tablespoon) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 30 mL (2 TBSP) (1 FL OZ) in the dosing cup provided every 4 hours while symptoms last do not take more than 150 mL (10 TBSP) (5 FL OZ) in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, anhydrous citric acid, FD&C yellow no. 6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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. 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion 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 In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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": [ "TYLENOL COLD MULTI-SYMPTOM DAYTIME Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Phenylephrine Hydrochloride Phenylephrine Alcohol anhydrous citric acid FD&C yellow no. 6 glycerin propylene glycol water sodium benzoate sorbitol sucralose Cooling citrus" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 30 mL (2 TBSP) (1 FL OZ) in the dosing cup provided every 4 hours while symptoms last do not take more than 150 mL (10 TBSP) (5 FL OZ) in 24 hours, unless directed by a doctor children under 12 years ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion 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. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each 15 mL = 1 tablespoon) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-257-08 See New Warnings Information TYLENOL ® COLD MULTI-SYMPTOM Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr Pain Reliever/Fever Reducer, Nasal Decongestant, Antitussive Headache, Fever, Sore Throat Nasal Congestion Cough DAYTIME Non-Drowsy Citrus Burst Alcohol 0.5% 8 fl oz (240 ml) Liquid Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each 15 mL = 1 tablespoon) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20120221", "inactive_ingredient": [ "INACTIVE INGREDIENTS acesulfame-potassium, anhydrous citric acid, D&C yellow # 10, FD&C red # 40, glycerin, NA bubble gum flavor FQ5511, polysorbate 80 (tween 80), purified water, sodium benzoate, sucrose, xanthan gum" ], "purpose": [ "OTC - PURPOSE Purpose Pain reliever/ fever reducer" ], "keep_out_of_reach_of_children": [ "OTC - 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 Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if your child: ■ has had stomach ulcers or bleeding problems ■ takes a blood thinning (anticoagulant) or steroid drug ■ takes other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others) ■ takes more or for a longer time than directed Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor." ], "when_using": [ "OTC - WHEN USING When using this product: ■ take with food or milk if stomach upset occurs ■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "OTC - QUESTIONS Questions or Comments? Call 1-877-835-5472, Monday through Friday 9AM - 5PM EST. Keep the carton. It contains important information. See end panel for expiration date. *This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Children’s Motrin ® ." ], "spl_product_data_elements": [ "Ibuprofen Pain Reliever/ Fever Reducer Ibuprofen IBUPROFEN IBUPROFEN ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 FD&C RED NO. 40 GLYCERIN POLYSORBATE 80 WATER SODIUM BENZOATE SUCROSE XANTHAN GUM" ], "ask_doctor": [ "OTC - ASK DOCTOR Ask a doctor before use if: ■ child has problems or serious side effects from taking pain relievers or fever reducers ■ stomach bleeding warning applies to your child ■ child has a history of stomach problems, such as heartburn ■ child has not been drinking fluids ■ child has lost a lot of fluid due to vomiting or diarrhea ■ child has high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ child has asthma ■ child is taking a diuretic" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Directions ■ this product does not contain directions or complete warnings for adult use ■ do not give more than directed ■ shake well before using ■ find right dose on chart below (if possible, use weight to dose; otherwise use age) ■ use only enclosed measuring cup ■ if needed, repeat dose every 6-8 hours ■ do not use more than 4 times a day ■ replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (tsp or mL) under 2 years ask a doctor 24-35 lbs 2-3 years 1 tsp or 5 mL 36-47 lbs 4-5 years 1 ½ tsp or 7.5 mL 48-59 lbs 6-8 years 2 tsp or 10 mL 60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL 72-95 lbs 11 years 3 tsp or 15 mL" ], "stop_use": [ "OTC - STOP USE Stop use and ask a doctor if: ■ child experiences any of the following signs of stomach bleeding ■ feels faint ■ vomits blood ■ has bloody or black stools ■ has stomach pain that does not get better ■ the child does not get any relief within the first day (24 hours) of treatment ■ fever or pain gets worse or lasts more than 3 days ■ redness or swelling is present in the painful area ■ any new symptoms appear" ], "spl_unclassified_section": [ "OTHER INFORMATION Other information ■ each teaspoon contains: sodium 2 mg ■ store between 20° to 25°C (68° to 77°F) ■ do not use if bottle wrap, or imprinted foil inner seal is broken or missing ■ see bottom panel for lot number and expiration date", "Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 07-2011" ], "do_not_use": [ "OTC - DO NOT USE Do not use: ■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 010ab916-figure-01 010ab916-figure-02 010ab916-figure-03" ], "indications_and_usage": [ "INDICATIONS AND USAGE Uses Temporarily: ■ Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache ■ Reduces fever" ], "set_id": "ae1cb9ae-9d01-47f0-b9ec-0d924d913514", "id": "010ab916-bc42-4e69-85d6-6585fc34226d", "ask_doctor_or_pharmacist": [ "OTC - ASK DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if the child is: ■ under doctor’s care for any serious condition ■ taking any other drug" ], "active_ingredient": [ "OTC - ACTIVE INGREDIENT Active Ingredient (in each 5 mL = 1 teaspoon) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tsp or mL)
under 2 years ask a doctor
24-35 lbs 2-3 years 1 tsp or 5 mL
36-47 lbs 4-5 years 1 ½ tsp or 7.5 mL
48-59 lbs 6-8 years 2 tsp or 10 mL
60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL
72-95 lbs 11 years 3 tsp or 15 mL
" ] }, { "effective_time": "20120130", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, D and C red no. 33, FD and C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose" ], "purpose": [ "Purpose 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. (1-800-222-1222)" ], "warnings": [ "Warnings to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in 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)" ], "when_using": [ "When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children" ], "questions": [ "Questions or comments? call 1-877-717-2824" ], "spl_product_data_elements": [ "Childrens Benadryl Allergy Cherry Flavored Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN AMMONIUM GLYCYRRHIZATE POLOXAMER 407 WATER SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE" ], "ask_doctor": [ "Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet" ], "other_safety_information": [ "Other information each 5 mL (1 tsp) contains: sodium 14 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used. do not use if bottle wrap, or foil inner seal imprinted \"SAFETY SEAL®\" is broken or missing see bottom panel for lot number and expiration date" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions find right dose on chart below mL = milliliter; tsp = teaspoonful take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours Age (yr) Dose (mL or tsp) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL (1 tsp) to 10 mL (2 tsp Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "do_not_use": [ "to make a child sleepy with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "NDC 50580-534-08 children's Benadryl® ALLERGY Diphenhydramine HCl 12.5 mg/5 mL oral solution Antihistamine Relieves Runny Nose Sneezing Itchy, Watery Eyes Itchy Throat Cherry FLAVORED LIQUID Alcohol Free THE HISTAMINE BLOCKER ® 8 fl oz (236 ml) Label for Benadryl Allergy Cherry - front Label for Benadryl Allergy Cherry - back" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "ae81a3d0-e448-4b21-8680-7d9a1c4c0d50", "id": "9b34d99d-2ff0-40ed-ac80-8e6774444c49", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers" ], "active_ingredient": [ "Active Ingredient Active ingredient (in each 5 mL = 1 teaspoonful) Diphenhydramine HCl 12.5 mg" ], "dosage_and_administration_table": [ "
Age (yr) Dose (mL or tsp)
children under 2 years do not use
children 2 to 5 years do not use unless directed by a doctor
children 6 to 11 years 5 mL (1 tsp) to 10 mL (2 tsp
" ] }, { "effective_time": "20120123", "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 right away. (1-800-222-1222)" ], "when_using": [ "do not exceed recommended dose 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 or comments? call 1-877-717-2824 Made in Canada Distributed by: McNeil Consumer Healthcare DIVISION OF MCNEIL-PPC, INC. FORT WASHINGTON, PA 19034 USA" ], "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 or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion stuffy nose temporarily relieves these symptoms due to the common cold: runny nose sneezing nasal congestion stuffy nose temporarily relieves sinus congestion and pressure" ], "set_id": "b01bdbb2-c7ba-4aa1-bd08-6a7a2d510287", "id": "958445c9-10a1-4b19-830f-77f4bc0d3383", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active Ingredients (in each 5 ml = 1 tsp) Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg" ], "dosage_and_administration_table": [ "
Age (yr) Dose (mL or tsp)
children under 4 years do not use
children 4 to 5 years do not use unless directed by a doctor
children 6 to 11 years 5 mL (1 tsp)
adults and children 12 years and over 10 mL (2 tsp)
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD and C blue no. 1, FD and C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "warnings": [ "Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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 trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers do not exceed recommended dose 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 symptoms do not improve within 7 days or occur with a 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. (1-800-222-1222)" ], "spl_product_data_elements": [ "Childrens Benadryl-D Allergy and Sinus Diphenhydramine HCl and Phenylephrine HCl Solution DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM EDETATE DISODIUM GLYCERIN FD&C BLUE NO. 1 FD&C RED NO. 40 WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma" ], "other_safety_information": [ "Other information each 5 mL (1 tsp) contains: sodium 10 mg store between 20-25°C (68–77°F). Protect from light. Store in outer carton until contents are used. do not use if bottle wrap or foil inner seal imprinted with \"SAFETY SEAL®\" is broken or missing see bottom panel for lot number and expiration date" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions find right dose on chart below mL = milliliter; tsp = teaspoonful take every 4 hours do not take more than 6 doses in 24 hours Age (yr) Dose (mL or tsp) children under 4 years do not use children 4 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL (1 tsp) adults and children 12 years and over 10 mL (2 tsp) Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever" ], "do_not_use": [ "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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 NDC 50580-781-04 children's Benadryl-D® ALLERGY and SINUS Diphenhydramine HCl/antihistamine Phenylephrine HCl/nasal decongestant oral solution Relieves Runny Nose Sneezing Itchy, Watery Eyes Itchy Throat Diphenhydramine HCl Sinus Congestion Stuffy Nose Phenylephrine HCl Grape FLAVORED LIQUID Alcohol and Sugar Free THE HISTAMINE BLOCKER ® 4 fl oz (118 ml) View of carton label" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Fever reducer/pain reliever" ], "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) 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. 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 • 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. 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) Quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "care one pain relief infants Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not give more than directed (see Liver warning) • shake well before using • 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 • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor • replace dropper tightly to maintain child resistance • this product does not contain directions or complete warnings for adult use Dosing Chart 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) Attention: use only enclosed dropper specifically designed for use with 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." ], "storage_and_handling": [ "Other information • store at 20°-25°C (68°-77°F) • do not use if printed bottle wrap is broken or missing" ], "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": [ "Principal Display Panel Compare to the Active Ingredient of Concentrated Tylenol® Infants’ Drops Infant's Pain Relief Fever Reducer/Pain Reliever Acetaminophen Concentrated Suspension Drops Grape Flavor Alcohol Free Aspirin Free Ibuprofen Free Use only with enclosed dropper See New Warnings Information 80 mg per 0.8 mL Infant's Pain Relief Carton Infant's Pain Relief Carton" ], "indications_and_usage": [ "Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "b030dd91-fc63-4519-b10d-0a0b86cd067e", "id": "dac2a50f-d057-42c8-a3be-cf82c7c9ac2e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each 0.8 mL) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Dosing Chart
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)
" ] } ] }