{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-02", "results": { "skip": 0, "limit": 100, "total": 172 } }, "results": [ { "effective_time": "20120503", "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 use more than directed." ], "questions": [ "Questions? 877-434-2036" ], "storage_and_handling": [ "Other information each teaspoon contains: sodium 2 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing." ], "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": "00ab90e8-7824-411f-bf4d-a540c2a8a4c3", "id": "3614e44e-8510-4fd2-9762-741b9659323d", "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": [ "
Age (yr) Dose (mL or tsp)
tsp. = teaspoon
mL = milliliter
under 6 mos. ask a doctor
6 mos. to under 2 2.5 mL or ½ tsp.
2 to under 4 5 mL or 1 tsp.
4 to under 6 7.5 mL or 1½ tsp.
6 to under 9 10 mL or 2 tsp.
9 to under 11 12.5 mL or 2½ tsp.
11 to under 12 15 mL or 3 tsp.
or as directed by a doctor
" ], "inactive_ingredient": [ "Inactive ingredients artificial flavor, citric acid anhydrous, corn syrup, D&C red #33, FD&C red #40, glycerin, 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 before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. 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. 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 the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens ACCUDIAL Pain reliever/ Fever reducer Acetaminophen Acetaminophen Acetaminophen Citric Acid Monohydrate Corn Syrup FD&C red no. 40 D&C red no. 33 Glycerin Cellulose, Microcrystalline Carboxymethylcellulose Sodium Propylene Glycol Water Sodium benzoate Sucralose Sorbitol Xanthan Gum" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease. Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions This product does not contain directions or complete warnings for adult use. shake well before using if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose. when weight is unknown: use the age chart on the rotating label. use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device Age (yr) Dose (mL or tsp) tsp. = teaspoon mL = milliliter under 6 mos. ask a doctor 6 mos. to under 2 2.5 mL or ½ tsp. 2 to under 4 5 mL or 1 tsp. 4 to under 6 7.5 mL or 1½ tsp. 6 to under 9 10 mL or 2 tsp. 9 to under 11 12.5 mL or 2½ tsp. 11 to under 12 15 mL or 3 tsp. or as directed by a doctor Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs." ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC. Palm Beach Gardens, FL 33408" ], "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 - 120 mL Bottle Carton Children's ACCUDIAL ® Acetaminophen Oral Suspension Pain Reliever / Fever Reducer For ages 6 mos. to under 12 yrs. or 12-95 lbs. Alcohol Free • Aspirin Free • Ibuprofen Free Compares to the active ingredient in Children's Tylenol ® Oral Suspension. ROTATING LABEL FOR WEIGHT-BASED DOSING Bubblegum Flavor 4 FL.OZ. (120 mL) 80 mg per 1/2 teaspoon (160 mg per 5 mL) NDC 45014-137-04 Principal Display Panel - 120 mL Bottle Carton" ] }, { "effective_time": "20111115", "inactive_ingredient": [ "Inactive ingredients Corn Syrup, FD&C Red 40, FD&C Blue 1, Flavors, Menthol, Purified Water, Sucrose, Titanium Dioxide." ], "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 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 chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions Call 1-800-344-7239 or write to Consumer Affairs." ], "spl_product_data_elements": [ "Sucrets Cough Cherry Dextromethorphan Hydrobromide DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CORN SYRUP FD&C RED NO. 40 FD&C BLUE NO. 1 MENTHOL WATER SUCROSE TITANIUM DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions adults and children 12 years of age and over: take 3 lozenges every 6-8 hours, do not take more than 12 lozenges per day children 6 to under 12 years of age: take 1 lozenge every 4 hours, do not take more than 6 lozenges per day children 4 to under 6 years of age: ask a doctor do not use in children under 4 years of age" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if 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 - 18 Lozenge Box SAFETY SEALED: Do not use if foil imprinted with \"Sucrets\" is torn or missing SUCRETS ® Dextromethorphan Hydrobromide–Cough Suppressant 8 Hour Cough Relief DMCOUGH FORMULA Made Stronger To Last Longer! ® 18 COUGH LOZENGES CHERRY Principle Display Panel - 18 Cough Lozenge Box" ], "indications_and_usage": [ "Uses temporarily suppresses coughs due to minor throat and bronchial irritation associated with a cold or inhaled irritants" ], "set_id": "00ad5b08-5371-4a2f-be49-4254106d7f64", "id": "3445f758-b0eb-4c92-aebf-0b67153848b1", "active_ingredient": [ "Active ingredient (per lozenge) Dextromethorphan Hydrobromide 10mg" ] }, { "effective_time": "20110826", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers increase drowsiness" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: runny nose and sneezing cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever" ], "set_id": "015d6dbd-d537-4c14-80c3-a7d4ed077fbf", "id": "6038afb7-254e-4b5c-b586-f5833c75c8d3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "dosage_and_administration_table": [ "
adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD and C blue no.1, FD and C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "spl_product_data_elements": [ "Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ALCOHOL CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE SUCROSE SUCRALOSE DOXYLAMINE SUCCINATE DOXYLAMINE" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland" ], "other_safety_information": [ "Other information each 30 mL dose cup contains: sodium 43 mg store at room temperature" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hours adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "Package label Night Time Cold/Flu Relief Original image of bottle label" ], "overdosage": [ "Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20121101", "inactive_ingredient": [ "Inactive ingredients Corn syrup, D&C yellow #10, FD&C blue #1, methyl salicylate, propylene glycol, sucrose, titanium dioxide, water" ], "purpose": [ "Purpose Oral anesthetic Oral anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor right away. Do not use more than 2 days or give to children under 12 years of age. Stop using this product and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-634-7680" ], "spl_product_data_elements": [ "Otis Clapp Thorets HEXYLRESORCINOL, MENTHOL HEXYLRESORCINOL HEXYLRESORCINOL MENTHOL MENTHOL CORN SYRUP D&C YELLOW NO. 10 FD&C BLUE NO. 1 METHYL SALICYLATE PROPYLENE GLYCOL SUCROSE TITANIUM DIOXIDE WATER green OVAL N Medi-First Plus Sore Throat Max HEXYLRESORCINOL, MENTHOL HEXYLRESORCINOL HEXYLRESORCINOL MENTHOL MENTHOL CORN SYRUP D&C YELLOW NO. 10 FD&C BLUE NO. 1 METHYL SALICYLATE PROPYLENE GLYCOL SUCROSE TITANIUM DIOXIDE WATER green OVAL N" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed Adults and children: (12 years and older) Allow 1 lozenge to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all warnings and directions before use. TAMPER EVIDENT: Do not use if packet is torn, ripped or shows any signs of tampering. store at room temperature 15º-30ºC (59º-86ºF) protect from moisture" ], "stop_use": [ "Stop using this product and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "package_label_principal_display_panel": [ "909B MFP Sore Throat Max Label 100 Lozenges 100 Pastillas Medi First® Plus Sore Throat Max Pull to Open Anesthetic Throat Lozenges Pastillas para el alivio del dolor de garganta Individually wrapped Throat Lozenges Individualmente Envuelto Pastillas para alivio del dolor de garganta Figure", "909B OC Thorets Label Otis Clapp Quality and Integrity Since 1840 THORETS ™ Sore Throat Lozenges Maximum Strength Anesthetic Throat Lozenges New Formula! Hexylresorcinol 2.4 mg Menthol 4.5 mg Tear Out Along Perforation To Dispense PROFESSIONAL HEALTHCARE 300 Lozenges Figure" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms occasional minor irritation pain sore mouth sore throat" ], "set_id": "022d0c43-baba-4523-9ffd-6beb5ef9dd03", "id": "3cc46011-479c-494f-a24a-573783c2588c", "active_ingredient": [ "Active ingredient (in each lozenge) Hexylrescorcinol 2.4mg Menthol 4.5mg" ] }, { "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": "20111115", "inactive_ingredient": [ "Inactive ingredients Acesulfame potassium, asorbic acid, corn syrup, FD&C red #40, dried pomegranate, green tea extract, natural and artificial blackberry, blueberry, raspberry and strawberry flavors, propylene glycol, sodium ascorbate, sucrose." ], "purpose": [ "Active ingredient (per lozenge) Purpose Menthol 5.0 mg Cough Suppressant Pectin 6.0 mg Demulcent" ], "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 Sore throat warning Severe or persistent sore throat or sore throat that occurs with or is followed by high fever, headache, rash, nausea or vomiting may be serious. Ask doctor right away. Do not use more than 2 days or give to children under 2 years of age unless directed by a doctor. Ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days cough lasts more than 7 days, comes back, or occurs with 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 CALL 1-800-344-7239" ], "spl_product_data_elements": [ "Sucrets Herbal Berry Pomegranate Menthol and Pectin MENTHOL MENTHOL PECTIN PECTIN ACESULFAME POTASSIUM ASCORBIC ACID CORN SYRUP FD&C RED NO. 40 POMEGRANATE BLACKBERRY BLUEBERRY PROPYLENE GLYCOL SODIUM ASCORBATE SUCROSE" ], "ask_doctor": [ "Ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions adults and children 3 years of age and older: Dissolve 1 lozenge slowly in the mouth. May be repeated every 1 hour as needed or as directed by a doctor or dentist. children under 3 years of age: consult a doctor or dentist." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "DIST. BY: INSIGHT PHARMACEUTICALS CORP. LANGHORNE, PA 19047-1749" ], "stop_use": [ "Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other Information Avoid storing at high temperature (greater than 100°F). Use only if lozenge blister seals are unbroken" ], "active_ingredient_table": [ "
Active ingredient (per lozenge) Purpose
Menthol 5.0 mg Cough Suppressant
Pectin 6.0 mg Demulcent
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL- 18 Lozenges Container SUCRETS ® HERBAL PECTIN / DEMULCENT • MENTHOL / COUGH SUPPRESSANT Serious Relief of Sore Throat Protects Irritated Throat Suppresses Cough PLUS Vitamin C 18 LOZENGES Made with Green Tea Berry Pomegranate 66006B Principal Display Panel - 18 Lozenges Container" ], "indications_and_usage": [ "Uses temporarily relieves: occasional minor irritation, pain, sore throat and sore mouth cough associated with a cold or inhaled irritants for protection of irritated areas in sore mouth and throat" ], "set_id": "08f56f2a-86c0-447b-9abb-e139cc6208e9", "id": "2cbbec9a-39e1-4440-b3e0-baead1077006", "purpose_table": [ "
Active ingredient (per lozenge) Purpose
Menthol 5.0 mg Cough Suppressant
Pectin 6.0 mg Demulcent
" ], "active_ingredient": [ "Active ingredient (per lozenge) Purpose Menthol 5.0 mg Cough Suppressant Pectin 6.0 mg Demulcent" ] }, { "effective_time": "20131212", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "questions": [ "Questions or Comments? 1-800-883-0085" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing" ], "set_id": "0901526a-2fa5-4555-928c-e55117110c6b", "id": "d56b2225-d9de-4cca-8e6b-310a344a0b85", "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 30mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients cherry extract, citric acid, ethanol, FD and C blue no.1, FD and C yellow no.5, high fructose corn syrup, I-menthol, methyl p-hydroxybenzoate, polyethylene glycol 400, polysorbate 80, propyl p-hydroxybenzoate, propylene glycol, purified water, sodium citrate, sodium saccharin" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "spl_product_data_elements": [ "Night Time Cold/Flu Relief Original Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOL 400 POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM CITRATE SACCHARIN SODIUM DIHYDRATE" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet" ], "other_safety_information": [ "Other information each 30 mL dose cup contains : sodium 11.32 mg store at room temperature" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "Package Label Nighttime Cold and Flu image of bottle label" ], "overdosage": [ "Overdose warning Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20121101", "inactive_ingredient": [ "Inactive ingredients corn syrup, D&C yellow no. 10, FD&C blue no. 1, methyl salicylate, propylene glycol, sucrose, titanium dioxide, water" ], "purpose": [ "Purpose Oral anesthetic Oral anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor right away. Do not use more than 2 days or give to children under 12 years of age. Stop using this product and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-634-7680" ], "spl_product_data_elements": [ "Medique Sepasoothe HEXYLRESORCINOL, MENTHOL HEXYLRESORCINOL HEXYLRESORCINOL MENTHOL MENTHOL CORN SYRUP D&C YELLOW NO. 10 FD&C BLUE NO. 1 METHYL SALICYLATE PROPYLENE GLYCOL SUCROSE TITANIUM DIOXIDE WATER green OVAL N" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed Adults and children : (12 years and older) Allow 1 lozenge to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all warnings and directions before use. TAMPER EVIDENT: Do not use if packet is torn, ripped or shows any signs of tampering. store at room temperature 15º-30ºC (59º-86ºF) protect from moisture" ], "stop_use": [ "Stop using this product and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days" ], "package_label_principal_display_panel": [ "909B Medique Sepasoothe Label Medique ® Sepasoothe Pull to Open Hexylresorcinol 2.4 mg Menthol 4.5 mg Anesthetic 24 Lozenges (24 x 1) 909B Medique Sepasoothe Label" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms occasional minor irritation pain sore mouth sore throat" ], "set_id": "0a122ebb-1f33-40ff-857e-861bee77ff57", "id": "5e47d38b-2b5f-44e9-a55a-2d9d27e1fe05", "active_ingredient": [ "Active ingredient (in each lozenge) Hexylresorcinol 2.4mg Menthol 4.5mg" ] }, { "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": "20120504", "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 use more than directed." ], "questions": [ "Questions? 877-434-2036" ], "storage_and_handling": [ "Other information each teaspoon contains: sodium 2 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing." ], "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": "12a94174-5a3d-4111-a48e-b84fbdfc9070", "id": "e3231b59-92e6-4c68-9e50-e469fc2c2958", "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": [ "
Age (yr) Dose (mL or tsp)
tsp. = teaspoon
mL = milliliter
under 6 mos. ask a doctor
6 mos. to under 2 2.5 mL or ½ tsp.
2 to under 4 5 mL or 1 tsp.
4 to under 6 7.5 mL or 1½ tsp.
6 to under 9 10 mL or 2 tsp.
9 to under 11 12.5 mL or 2½ tsp.
11 to under 12 15 mL or 3 tsp.
or as directed by a doctor
" ], "inactive_ingredient": [ "Inactive ingredients artificial flavor, citric acid anhydrous, corn syrup, glycerin, 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 before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. 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. 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 the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens ACCUDIAL Pain reliever/ Fever reducer Acetaminophen Acetaminophen Acetaminophen Cherry Citric Acid Monohydrate Corn Syrup Glycerin Cellulose, Microcrystalline Carboxymethylcellulose Sodium Propylene Glycol Water Sodium benzoate Sucralose Sorbitol Xanthan Gum" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease. Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions This product does not contain directions or complete warnings for adult use. shake well before using if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose. when weight is unknown: use the age chart on the rotating label. use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device Age (yr) Dose (mL or tsp) tsp. = teaspoon mL = milliliter under 6 mos. ask a doctor 6 mos. to under 2 2.5 mL or ½ tsp. 2 to under 4 5 mL or 1 tsp. 4 to under 6 7.5 mL or 1½ tsp. 6 to under 9 10 mL or 2 tsp. 9 to under 11 12.5 mL or 2½ tsp. 11 to under 12 15 mL or 3 tsp. or as directed by a doctor Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs." ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC. Palm Beach Gardens, FL 33408" ], "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 - 120 mL Bottle Carton Children's ACCUDIAL ® Acetaminophen Oral Suspension Pain Reliever / Fever Reducer For ages 6 mos. to under 12 yrs. or 12-95 lbs. Alcohol Free • Aspirin Free • Ibuprofen Free Compares to the active ingredient in Children's Tylenol ® Oral Suspension. ROTATING LABEL FOR WEIGHT-BASED DOSING Dye-Free Cherry Flavor 4 FL.OZ. (120 mL) 80 mg per 1/2 teaspoon (160 mg per 5 mL) NDC 45014-139-04 Principal Display Panel - 120 mL Bottle Carton" ] }, { "effective_time": "20100603", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "questions": [ "Questions? 1-800-362-1683" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains: potassium 5 mg, sodium 19 mg store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing" ], "set_id": "17387d2c-8895-4d57-b0ba-2113bed742db", "id": "5bf4433c-09e7-4e6b-a440-88729c4a389a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "dosage_and_administration_table": [ "
adults & children 12 yrs and over 30 ml (2 TBSP) every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, alcohol, citric acid, FD&C Blue 1, FD&C Red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate" ], "warnings": [ "Warnings Liver warning Product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hrs with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than directed dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Vicks NyQuil Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine succinate Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Doxylamine succinate Doxylamine" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hrs adults & children 12 yrs and over 30 ml (2 TBSP) every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other DayQuil® or NyQuil products, carefully read each label to insure correct dosing" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202. www.vicks.com" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 295 ml Bottle Label Special Edition Cherry Vanilla Swirl VICKS ® NyQuil ® COLD & FLU Multi-Symptom Relief Acetaminophen…Aches, Fever Dextromethorphan…Cough Doxylamine…Sneezing, Runny Nose 10 FL OZ (295 ml) Alcohol 10% See Drug Facts Principle Display Panel - 295 ml Bottle Label" ], "overdosage": [ "Overdose warning Taking more than directed dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20111020", "inactive_ingredient": [ "Inactive ingredients Acesulfame potassium, asorbic acid, corn syrup, D&C yellow #10, green tea extract, natural and artificial honey and lemon flavors, propylene glycol, Siberian ginseng powder, sodium ascorbate, sucrose." ], "purpose": [ "Active ingredient (per lozenge) Purpose Menthol 5.0 mg Cough Suppressant Pectin 6.0 mg Demulcent" ], "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 Sore throat warning Severe or persistent sore throat or sore throat that occurs with or is followed by high fever, headache, rash, nausea or vomiting may be serious. Ask doctor right away. Do not use more than 2 days or give to children under 2 years of age unless directed by a doctor. Ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days cough lasts more than 7 days, comes back, or occurs with 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 CALL 1-800-344-7239" ], "spl_product_data_elements": [ "Sucrets Herbal Honey Lemon Ginseng Menthol and Pectin MENTHOL MENTHOL PECTIN PECTIN ACESULFAME POTASSIUM ASCORBIC ACID CORN SYRUP D&C YELLOW NO. 10 PROPYLENE GLYCOL ELEUTHERO SODIUM ASCORBATE SUCROSE" ], "ask_doctor": [ "Ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions adults and children 3 years of age and older: Dissolve 1 lozenge slowly in the mouth. May be repeated every 1 hour as needed or as directed by a doctor or dentist. children under 3 years of age: consult a doctor or dentist." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "DIST. BY: INSIGHT PHARMACEUTICALS CORP. LANGHORNE, PA 19047-1749" ], "stop_use": [ "Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other Information Avoid storing at high temperature (greater than 100°F). Use only if lozenge blister seals are unbroken" ], "active_ingredient_table": [ "
Active ingredient (per lozenge) Purpose
Menthol 5.0 mg Cough Suppressant
Pectin 6.0 mg Demulcent
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 18 Lozenges Container SUCRETS ® HERBAL PECTIN / DEMULCENT • MENTHOL / COUGH SUPPRESSANT Serious Relief of Sore Throat Protects Irritated Throat Suppresses Cough PLUS Vitamin C 18 LOZENGES Made with Green Tea Honey Lemon Ginseng 66005B Principle Display Panel - 18 Lozenges Container" ], "indications_and_usage": [ "Uses temporarily relieves: occasional minor irritation, pain, sore throat and sore mouth cough associated with a cold or inhaled irritants for protection of irritated areas in sore mouth and throat" ], "set_id": "18af4012-0ccd-45c8-b18a-53b1e4be6419", "id": "8b157ae8-8559-44c6-a54d-a45c65fbf547", "purpose_table": [ "
Active ingredient (per lozenge) Purpose
Menthol 5.0 mg Cough Suppressant
Pectin 6.0 mg Demulcent
" ], "active_ingredient": [ "Active ingredient (per lozenge) Purpose Menthol 5.0 mg Cough Suppressant Pectin 6.0 mg Demulcent" ] }, { "effective_time": "20091103", "spl_unclassified_section_table": [ "
Age Dose
adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet daily
children under 6 ask a doctor
consumers who have liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS artificial & natural flavor, aspartame, citric acid, colloidal silicon dioxide, corn syrup solids, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, modified food starch, sodium bicarbonate" ], "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." ], "warnings": [ "WARNINGS Do not use 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 or kidney disease. Your doctor should determine if you need a different dose. When using this product do not use more than directed. Taking more than recommended may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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. Taking more than recommended may cause drowsiness." ], "questions": [ "QUESTIONS OR COMMENTS? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675" ], "spl_product_data_elements": [ "CHILDRENS DIMETAPP NON-DROWSY ALLERGY ODT loratadine loratadine loratadine white to off white flat faced round beveled tablet A;24 Flat minty flavor" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "3", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "DIRECTIONS tablet melts in mouth. Can be taken with or without water. Age Dose adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet daily children under 6 ask a doctor consumers who have liver or kidney disease ask a doctor", "OTHER INFORMATION Phenylketonurics: Contains Phenylalanine 8.4 mg per tablet store at 20-25ºC (68-77ºF) keep in a dry place" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients" ], "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. Children’s Dimetapp ND Non-Drowsy* Allergy Loratadine Orally Disintegrating Tablet, 10mg, Antihistamine 24 Hr. Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes, Itching of Nose & Throat 24 Hour COOL BLAST MELTS IN YOUR MOUTH 12 Orally Disintegrating Tablets *When taken as directed, see DRUG FACTS Panel. Visit our website at www.dimetapp.com Wyeth Distributed by: Wyeth Consumer Healthcare Madison, NJ 07940 EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN. Children's Dimetapp ND (Non-Drowsy) Allergy Packaging" ], "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": "1b139418-4836-abc9-de65-f78b38538f02", "id": "0f1d2f40-5352-3f1c-55c6-6d93c2ad2808", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine 10 mg" ] }, { "effective_time": "20120619", "inactive_ingredient": [ "NON-MEDICINAL INGREDIENTS: NATURAL FLAVOURS (HONEY LEMON, LEMON), NATURAL COLOURS (BETA CAROTENE, CURCUMIN), CITRIC ACID, CORN SYRUP, SUGAR, HONEY." ], "purpose": [ "RECOMMENDED USE: FOR THE TEMPORARY RELIEF OF COUGH AND SORE THROAT." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "RISK INFORMATION: CONSULT A HEALTH CARE PRACTITIONER IF SYMPTOMS PERSIST OR WORSEN, IF SORE THROAT SYMPTOMS ARE SEVERE OR PERSIST FOR MORE THAN TWO DAYS, IF COUGH WORSENS, PERSISTS FOR MORE THAN SEVEN DAYS OR IS ACCOMPANIED BY HIGH FEVER. CONSULT A HEALTH CARE PRACTITIONER PRIOR TO USE IF YOU TAKE IMMUNOSUPPRESSANTS OR HAVE A PROGRESSIVE SYSTEMIC DISEASE SUCH AS TUBERCULOSIS, LEUKOSIS, COLLAGENOSIS OR MULTIPLE SCLEROSIS." ], "spl_product_data_elements": [ "Herbon Original Lemon Honey Menthol and Echinacea Purpurea Menthol Menthol Echinacea Purpurea Echinacea Purpurea Citric Acid Monohydrate Sucrose Corn Syrup Honey Transulucent golden yellow with opaque yellow speckles" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "RECOMMENDED DOSE: ADOLESCENTS (10 TO 14 YEARS): DISSOLVE 1 LOZENGE SLOWLY IN THE MOUTH THREE TIMES DAILY OR MORE AS NEEDED. ADULTS AND ADOLESCENTS (14 YEARS AND OLDER): DISSOLVE 1 LOZENGE SLOWLY IN THE MOUTH SIX TIMES DAILY OR MORE AS CONSULT A HEALTH CARE PRACTITIONER FOR USE BEYOND 8 WEEKS." ], "storage_and_handling": [ "STORE IN A COOL, DRY PLACE." ], "do_not_use": [ "DO NOT USE IF PACKAGE IS OPEN OR TORN." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 10 Lozenges Herbon ® ECHINACEA Cough and Sore Throat Drops Original ALL NATURALLY-SOURCED ACTIVE INGREDIENTS LEMON HONEY 10 Lozenges Principal Display Panel" ], "indications_and_usage": [ "RECOMMENDED USE: FOR THE TEMPORARY RELIEF OF COUGH AND SORE THROAT." ], "set_id": "1b379002-e777-43a1-8b44-1ce7055979d0", "id": "5549489c-a05d-43a4-b94a-e73a92248685", "active_ingredient": [ "MEDICINAL INGREDIENTS: EACH LOZENGE CONTAINS: ECHINACEA (Echinacea purpurea) ROOT EXTRACT 22:1 (EQUIVALENT TO 162 MG DRIED HERB) 7.35 MG, MENTHOL (FROM Mentha arvensis LEAF) 8 MG." ] }, { "effective_time": "20120620", "inactive_ingredient": [ "Non-medicinal Ingredients: Natural flavours (chocolate, peppermint, wintermint), natural colour (carmine), corn syrup, sugar, cocoa powder." ], "purpose": [ "Recommended Use: For the temporary relief of cough and sore throat pain. Helps ease nasal congestion and make nasal passages feel clearer. Helps shorten the duration and relieve symptoms of the common cold." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "Risk Information: Consult a health care practitioner if symptoms persist or worsen, if sore throat symptoms are severe or persist for more than two days, if cough worsens, persists for more than seven days or is accompanied by high fever. Consult a health care practitioner prior to use if you take immunosuppressants or have a progressive systemic disease such as tuberculosis, leukosis, collagenosis or multiple sclerosis." ], "spl_product_data_elements": [ "Herbon Rockhopper Chocomint Menthol and Echinacea Purpurea Menthol Menthol Echinacea Purpurea Echinacea Purpurea Cocoa Sucrose Corn Syrup Slightly opaque deep brown with deep pink speckles Herbon Rockhopper Chocomint Menthol and Echinacea Purpurea Menthol Menthol Echinacea Purpurea Echinacea Purpurea Cocoa Sucrose Corn Syrup Slightly opaque deep brown with deep pink speckles" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Recommended Dose: Adolescents (10 to 14 years): Dissolve 1 lozenge slowly in the mouth three times daily or more as needed. Adults and adolescents (14 years and older): Dissolve 1 lozenge slowly in the mouth six times daily or more as needed. Note: Do not exceed 14 lozenges per day. Consult a health care practitioner for use beyond eight weeks." ], "storage_and_handling": [ "STORE IN A COOL, DRY PLACE." ], "do_not_use": [ "DO NOT USE IF BAG IS OPEN OR TORN." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 20 Lozenge Bag Herbon ® ROCKHOPPERS TM/MC ECHINACEA Cough and Sore Throat Drops Temporary Relief of Cough & Sore Throat Helps Ease Nasal Congestion ALL NATURALLY-SOURCED ACTIVE INGREDIENTS CHOCOMINT REFRESHING BURSTS of WINTERMINT 20 Lozenges Principal Display Panel - 20 Lozenge Bag", "PRINCIPAL DISPLAY PANEL - 10 Lozenge Bag Herbon ® ROCKHOPPERS TM/MC ECHINACEA Cough and Sore Throat Drops ALL NATURALLY-SOURCED ACTIVE INGREDIENTS CHOCOMINT 10 Lozenges Principal Display Panel - 10 Lozenge Bag" ], "indications_and_usage": [ "INDICATIONS AND USAGE Recommended Use: For the temporary relief of cough and sore throat pain. Helps ease nasal congestion and make nasal passages feel clearer. Helps shorten the duration and relieve symptoms of the common cold." ], "set_id": "1d68241c-f4a7-4e90-a125-92e01307f2fd", "id": "85e93a8f-1a3d-4abb-a011-7306b8c6d8fa", "active_ingredient": [ "Medicinal Ingredients: Each lozenge contains: Echinacea (Echinacea purpurea) root extract 22:1 (equivalent to 162 mg dried herb) .....................................7.35 mg Menthol (from Mentha arvensis leaf) ...................................6.5 mg" ] }, { "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": "20121011", "inactive_ingredient": [ "Inactive ingredients carboxymethylcellulose sodium, citric acid, D&C Yellow No. 10, FD&C Yellow No. 6, flavor, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if you have a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-800-251-3374" ], "spl_product_data_elements": [ "Vicks DayQuil Mucus Control Guaifenesin Guaifenesin Guaifenesin carboxymethylcellulose sodium citric acid monohydrate D&C Yellow No. 10 FD&C Yellow No. 6 high fructose corn syrup propylene glycol water saccharin sodium dihydrate sodium benzoate sodium citrate" ], "ask_doctor": [ "Ask a doctor before use if you have a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions use dose cup or tablespoon (TBSP) do not exceed 6 doses per 24 hours adults and children 12 years and over 30 ml (2 TBSP) every 4 hours children 6 to under 12 years 15 ml (1 TBSP) every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use when using other DayQuil or NyQuil® products, carefully read each label to insure correct dosing" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202. www.vicks.com" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each tablespoon contains sodium 25 mg store at room temperature" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 295 ml Bottle Label NEW VICKS ® NON-DROWSY DayQuil ® Mucus Control™ EXPECTORANT Maximum Strength 4 hour Formula Guaifenesin...Expectorant 10 FL OZ (295 ml) Citrus Blend Flavor See Drug Facts Principle Display Panel - 295 ml Bottle Label" ], "indications_and_usage": [ "Use helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus" ], "set_id": "21064f47-f23d-4da1-8faf-3c6842893864", "id": "fec90bc7-4524-4b74-9d3b-32fdee3bd608", "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Guaifenesin 200 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 30 ml (2 TBSP) every 4 hours
children 6 to under 12 years 15 ml (1 TBSP) every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years do not use
" ] }, { "effective_time": "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": "20130731", "inactive_ingredient": [ "Inactive ingredients corn starch, corn syrup, corn syrup solids, FD&C red #40, flavoring, glycerin, hydrogenated coconut oil, maltodextrin, sorbitol, soy lecithin, soy protein, sucrose, and titanium dioxide" ], "purpose": [ "Active ingredients (in each chew) Purpose Calcium carbonate 1177 mg Antacid Simethicone 80 mg Antigas" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs. Do not take more than 6 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. Keep out of reach of children." ], "when_using": [ "Do not take more than 6 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician." ], "questions": [ "Questions? call 1-800-223-0182" ], "spl_product_data_elements": [ "Rolaids Plus Calcium Carbonate and Dimethicone Calcium Carbonate Carbonate ion Dimethicone Dimethicone starch, corn corn syrup FD&C red no. 40 glycerin hydrogenated coconut oil maltodextrin sorbitol lecithin, soybean soy protein sucrose titanium dioxide Off white to Tan Cube Tropical Fruit" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions chew and swallow 2 to 3 chews, hourly if needed" ], "spl_unclassified_section": [ "Drug Facts" ], "storage_and_handling": [ "Other information each chew contains: calcium 510 mg, magnesium 5 mg, sodium 2 mg contains soy store between 20 - 25° C (68 - 77° F) in a dry place tamper evident statement see back panel for lot number and expiration date" ], "active_ingredient_table": [ "
Active ingredients (in each chew) Purpose
Calcium carbonate 1177 mg Antacid
Simethicone 80 mg Antigas
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Image not available Principal Display Panel" ], "indications_and_usage": [ "Uses relieves: heartburn sour stomach acid indigestion upset stomach due to these symptoms bloating, pressure, and discomfort commonly referred to as gas" ], "set_id": "22d9b22a-e438-4158-890a-2d03506ac6f0", "id": "b481a7a3-3deb-4ea9-ab10-4ffda70fbfd5", "purpose_table": [ "
Active ingredients (in each chew) Purpose
Calcium carbonate 1177 mg Antacid
Simethicone 80 mg Antigas
" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each chew) Purpose Calcium carbonate 1177 mg Antacid Simethicone 80 mg Antigas" ] }, { "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": "20110826", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers increase drowsiness" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing" ], "set_id": "28b74efa-fbf4-4cc4-85e8-56807c773ee6", "id": "e1147c11-b7c7-4426-8dae-835da9205faa", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "dosage_and_administration_table": [ "
adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD and C blue no.1, FD and C yellow no.5, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "spl_product_data_elements": [ "Night Time Cold/Flu Relief Original Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ALCOHOL CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE SUCROSE SUCRALOSE DOXYLAMINE SUCCINATE DOXYLAMINE" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland" ], "other_safety_information": [ "Other information each 30 mL dose cup contains: sodium 43 mg store at room temperature" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hours adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "Package label Night Time Cold/Flu Relief Original image of bottle label" ], "overdosage": [ "Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20120306", "purpose": [ "Active ingredients (in each lozenge) Purpose Benzocaine 15 mg Oral pain reliever Menthol 3.6 mg Oral pain reliever" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Do not exceed recommended dosage." ], "questions": [ "Questions? Call 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 tamper evident: product is sealed in blister package for your protection. Do not use if carton or blister package has been disturbed or opened. store at room temperature 20-25°C (68-77°F) protect contents from humidity" ], "indications_and_usage": [ "Uses temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores" ], "set_id": "29757715-e851-4e9f-b0a9-6fc05dda0205", "id": "29757715-e851-4e9f-b0a9-6fc05dda0205", "active_ingredient": [ "Active ingredients (in each lozenge) Purpose Benzocaine 15 mg Oral pain reliever Menthol 3.6 mg Oral pain reliever" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, cetylpyridinium chloride, corn syrup, D&C red #33, FD&C red #40, flavors, propylene glycol, purified water, sodium bicarbonate, sucrose" ], "warnings": [ "Warnings Allergy alert Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics. 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 5 years of age. Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage." ], "spl_product_data_elements": [ "Cepacol Sore Throat Benzocaine and Menthol Benzocaine Benzocaine Menthol Menthol acesulfame potassium cetylpyridinium chloride corn syrup D&C red no. 33 FD&C red no. 40 propylene glycol water sodium bicarbonate sucrose C" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: do not use" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224 Repackaged by: Rebel Distributors Corp, Thousand Oaks, CA 91320" ], "stop_use": [ "Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops" ], "do_not_use": [ "Do not use in a child under 5 years of age." ], "active_ingredient_table": [ "
Active ingredients (in each lozenge) Purpose
Benzocaine 15 mg Oral pain reliever
Menthol 3.6 mg Oral pain reliever
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Cepacol 15mg/3.6mg" ], "purpose_table": [ "
Active ingredients (in each lozenge) Purpose
Benzocaine 15 mg Oral pain reliever
Menthol 3.6 mg Oral pain reliever
" ] }, { "effective_time": "20150730", "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, alcohol, cherry essence, citric acid hydrate, FD&C Blue No. 1, FD&C Red No. 40, high fructose corn syrup, L-menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate hydrate, sodium saccharin" ], "indications_and_usage_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
" ], "purpose": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever running nose and sneezing" ], "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. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "when_using": [ "When using this product excitability may occur, especially in chldren marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "spl_product_data_elements": [ "Family Care Cold and Flu Multi Symptom Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACESULFAME POTASSIUM ALCOHOL CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP MENTHOL METHYLPARABEN POLYETHYLENE GLYCOLS PROPYLENE GLYCOL PROPYLPARABEN WATER" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet", "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thining drug warfarin" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Distributed by: United Exchange Corp. Cerritos, CA 90703 U.S.A. Made in Korea" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each 30 mL dose cup contains: potassium 3 mg sodium 7 mg store at room temperature" ], "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 presction monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "Directions take only as directed use dose cup or tablespoon (TBSP) 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" ], "set_id": "29d67a45-780f-4749-8b39-9f9ef4081874", "id": "a729707a-4add-4db6-aa48-cf71bcc9e2d8", "active_ingredient": [ "Active ingredients (in each 30 mL dose cup) Purpose Acetaminophen 650 mg...............................................Pain reliever/fever reducer Dextromethorphan HBr 30 mg................................................Cough suppressant Doxylamine succinate 12.5 mg.......................................................Antihistamine" ] }, { "effective_time": "20120618", "inactive_ingredient": [ "Non-medicinal Ingredients: Natural flavours (cinnamon, peppermint, wintermint), natural colour (carmine), corn syrup, sugar." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "Risk Information: Consult a health care practitioner if symptoms persist or worsen, if sore throat symptoms are severe or persist for more than two days, if cough worsens, persists for more than seven days or is accompanied by high fever. Consult a health care practitioner prior to use if you take immunosuppressants or have a progressive systemic disease such as tuberculosis, leukosis, collagenosis or multiple sclerosis." ], "spl_product_data_elements": [ "Herbon Cinnagreen Menthol and Echinacea Purpurea Menthol Menthol Echinacea Purpurea Echinacea Purpurea Sucrose Corn Syrup Translucent golden yellow with opaque yellow speckles Herbon Cinnagreen Menthol and Echinacea Purpurea Menthol Menthol Echinacea Purpurea Echinacea Purpurea Sucrose Corn Syrup Translucent golden yellow with opaque yellow speckles" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Recommended Dose: Adolescents (10 to 14 years): Dissolve 1 lozenge slowly in the mouth three times daily or more as needed. Adults and adolescents (14 years and older): Dissolve 1 lozenge slowly in the mouth six times daily or more as needed. Note: Do not exceed 14 lozenges per day. Consult a health care practitioner for use beyond eight weeks." ], "storage_and_handling": [ "STORE IN A COOL, DRY PLACE." ], "do_not_use": [ "DO NOT USE IF BAG IS OPEN OR TORN." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 20 Lozenge Bag Herbon ® ECHINACEA Cough and Sore Throat Drops Original Temporary Relief of Cough & Sore Throat Helps Ease Nasal Congestion ALL NATURALLY-SOURCED ACTIVE INGREDIENTS CINNAGREEN REFRESHING BURTS of WINTERMINT 20 Lozenges Principal Display Panel", "PRINCIPAL DISPLAY PANEL - 10 Lozenge Bottle Label Herbon ® ECHINACEA Cough and Sore Throat Drops Original ALL NATURALLY-SOURCED ACTIVE INGREDIENTS CINNAGREEN 10 Lozenges Principal Display Panel - 10 Lozenge Bottle Label" ], "indications_and_usage": [ "Recommended Use: For the temporary relief of cough and sore throat pain. Helps relieve nasal congestion and make nasal passages feel clearer. Helps shorten the duration and relieve symptoms of the common cold." ], "set_id": "2bd2b499-99df-4d6f-9327-4fe953339f17", "id": "1e97f449-2f56-45e2-bb4d-300b852c0c83", "active_ingredient": [ "Medicinal Ingredients: Each lozenge contains: Echinacea (Echinacea purpurea) root extract 22:1 (equivalent to 162 mg dried herb) ................................7.35 mg Menthol (from Mentha arvensis leaf) ................................... 8 mg" ] }, { "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": "20150122", "purpose": [ "Active ingredients (in each lozenge) Purpose Dextromethorphan HBr 5 mg Cough suppressant Menthol 5 mg Oral pain reliever" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Or to report an adverse event call 1-800-245-2898. Monday-Friday 8AM to 4PM EST" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing. store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms: sore throat sore mouth minor mouth irritation cough due to minor throat and bronchial irritation as may occur with the common cold" ], "set_id": "354d3cef-0976-4f8d-aad1-fe6907c2f507", "id": "ed8ffdca-53a0-4325-86e7-de6c7894caa2", "ask_doctor_or_pharmacist": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient": [ "Active ingredients (in each lozenge) Purpose Dextromethorphan HBr 5 mg Cough suppressant Menthol 5 mg Oral pain reliever" ], "inactive_ingredient": [ "Inactive ingredients Corn syrup, FD C yellow 10, FD C yellow 6, glycerin, natural and artificial flavors, propylene glycol, sucralose and water. Soybean oil and corn starch use as processing aids." ], "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 in a child under 6 years of age. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that is accompanied by excessive phlegm (mucus) Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling develops cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "BestHealth Cough Relief Honey Lemon Flavor DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN MENTHOL MENTHOL CORN SYRUP D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL SUCRALOSE WATER SOYBEAN OIL STARCH, CORN B" ], "ask_doctor": [ "Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that is accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor children under 6 years of age, do not use" ], "spl_unclassified_section": [ "BestHealth Cough Relief Honey Lemon Flavor" ], "stop_use": [ "Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling develops 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 under 6 years of age." ], "active_ingredient_table": [ "
Active ingredients (in each lozenge) Purpose
Dextromethorphan HBr 5 mg Cough suppressant
Menthol 5 mg Oral pain reliever
" ], "package_label_principal_display_panel": [ "BestHealth Cough Relief Honey Lemon Flavor 16 Count (52642-006-16) HoneyLemonFlavor" ], "purpose_table": [ "
Active ingredients (in each lozenge) Purpose
Dextromethorphan HBr 5 mg Cough suppressant
Menthol 5 mg Oral pain reliever
" ] }, { "effective_time": "20120711", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: runny nose and sneezing cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever" ], "set_id": "36263ccb-c5b2-42e0-bc16-b4b4000671bc", "id": "649e7b4c-23a5-4b95-8947-6a0afaa3701c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each 30 ml dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD and C blue no.1, FD and C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose, xanthan gum" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "spl_product_data_elements": [ "Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ALCOHOL CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SACCHARIN SODIUM DIHYDRATE SODIUM CITRATE SUCROSE SUCRALOSE DOXYLAMINE SUCCINATE DOXYLAMINE XANTHAN GUM" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet" ], "other_safety_information": [ "Other information each 30 mL dose cup contains : sodium 43 mg store at room temperature" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "Package label Night Time Cold/Flu Relief Cherry image of bottle label" ], "overdosage": [ "Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20130206", "inactive_ingredient": [ "Inactive ingredients artificial flavor, citric acid, corn syrup FD&C blue #1, D&C red #33, glycerin, purified water sodium benzoate, sodium saccharin, sucralose, xanthan gum." ], "ask_doctor_or_pharmacist_table": [ "
Age (yr) Dose (TSP)
TSP = teaspoon
under 4 yrs. ask a doctor
4 to under 6 ½ TSP to 1 TSP
6 to under 12 1 TSP to 2 TSP
or as directed by a doctor
" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Ask a doctor before use if the child has a cough that occurs with too much phlegm (mucus) or persistant or chronic cough such as occurs with asthma. Directions may be given every 4 hours do not use more than 6 times in 24 hours use only enclosed dosing cup to dose this product. Do not use any other dosing device. 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. Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product. Age (yr) Dose (TSP) TSP = teaspoon under 4 yrs. ask a doctor 4 to under 6 ½ TSP to 1 TSP 6 to under 12 1 TSP to 2 TSP or as directed by a doctor Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms." ], "questions": [ "Questions? 877-434-2036" ], "spl_product_data_elements": [ "Chest Congestion Guaifenesin Guaifenesin Guaifenesin Citric Acid Monohydrate Corn Syrup FD&C Blue No. 1 D&C Red No. 33 Glycerin Water Sodium Benzoate Saccharin Sodium Sucralose Xanthan Gum" ], "ask_doctor": [ "Ask a doctor before use if the child has a cough that occurs with too much phlegm (mucus) or persistant or chronic cough such as occurs with asthma." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions may be given every 4 hours do not use more than 6 times in 24 hours use only enclosed dosing cup to dose this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: AccuDial® Pharmaceutical, Inc. Palm Beach Gardens, FL 33408" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness." ], "storage_and_handling": [ "Other information each teaspoon contains: sodium 3 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton ACCU DIAL ® Children's Chest Congestion Guaifenesin Oral Solution Expectorant Relieves Chest Congestion Thins & Loosens Mucus Earth-Friendly Package! For Ages 4 yrs to under 12 yrs Tamper Evident Compares to Mucinex ® For Kids GRAPE FLAVOR NDC 45014-163-04 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": "37c6ebc3-55fe-4158-a5d6-05c5b4bb5f50", "id": "c7ba2caf-ed17-4171-b900-4d3e0155cdc4", "ask_doctor_or_pharmacist": [ "Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product. Age (yr) Dose (TSP) TSP = teaspoon under 4 yrs. ask a doctor 4 to under 6 ½ TSP to 1 TSP 6 to under 12 1 TSP to 2 TSP or as directed by a doctor" ], "warnings_table": [ "
Age (yr) Dose (TSP)
TSP = teaspoon
under 4 yrs. ask a doctor
4 to under 6 ½ TSP to 1 TSP
6 to under 12 1 TSP to 2 TSP
or as directed by a doctor
" ], "active_ingredient": [ "Active ingredient (in each 5 mL = 1 teaspoon) Guaifenesin, USP 100 mg" ] }, { "effective_time": "20150729", "inactive_ingredient": [ "Inactive ingredients citric acid hydrate, FD&C red no. 40, fruit mixing essence, glycerin, high fructose corn syrup, L-menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate hydrate, sucralose" ], "indications_and_usage_table": [ "
age dose
adults and children 12 years and over 10 mL every 4 hours
children under 12 years do not use
" ], "purpose": [ "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 brnchial tubes." ], "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 until 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." ], "spl_product_data_elements": [ "Family Care Cough and Cold Dextromethorphan hydrobromide, and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP MENTHOL POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Distributed by: United Exchange Corp. 17211 Valley View Ave. Cerritos, CA 90703 USA Made in Korea" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each 10 mL contains: sodium 3 mg Store at 20° to 25°C (68° to 77°F). Do not refrigerate." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "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" ], "set_id": "3bb3a81d-d39a-4f79-84f1-ab0c075d7d34", "id": "2fd95da5-2608-4030-a124-4e16f9c0a824", "active_ingredient": [ "Active ingredients (in each 10 mL) Purpose Dextromethorphan HBr, USP 20 mg............................................Cough suppressant Guaifenesin, USP 200 mg....................................................................Expectorant" ] }, { "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": "20120618", "inactive_ingredient": [ "Inactive Ingredients: Canola Oil, Corn Syrup, Echinacea Angustifolia, Echinacea Purpurea, Malic Acid, Natural Banana and Honey Flavoring, Natural Color, Sucrose, Vitamin C blend (Ascorbic Acid and Sodium Ascorbate)." ], "purpose": [ "Purpose Oral Demulcent" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. Consult a physician promptly. If symptoms are severe, do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician. Ask a doctor before use if you have: persistent or chronic cough associated with smoking, asthma, or emphysema. cough accompanied by excessive phlegm (mucus). Stop use and ask a doctor if: sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. sore mouth symptoms do not improve in 7 days. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children." ], "questions": [ "Questions? 800-421-2998" ], "spl_product_data_elements": [ "Herbon Banana Man Goodypops Pectin and Echinacea Purpurea Pectin Pectin Echinacea Purpurea Echinacea Purpurea Sucrose Corn Syrup Malic Acid Ascorbic Acid Sodium Ascorbate Echinacea Purpurea Pale yellow/beige candied head lollipop with white stick" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults and children 3 years of age and older: allow Goodypop to dissolve slowly in the mouth. May be repeated as needed or as directed by a physician. Children under 3 years of age: consult a physician." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if: sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. sore mouth symptoms do not improve in 7 days." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 8 Goodypops herbon ® kids Soothes Your Child's Sore Throat 8 GOODYPOPS BananaMan & BUZZBEE ® also contains Echinacea + Vitamin C Banana Honey Flavor Net Wt 2.3oz (65g) Principal Display Panel" ], "indications_and_usage": [ "Uses For the temporary relief of: minor discomfort and protection of irritated areas in sore mouth and sore throat." ], "set_id": "3ce70e8a-6a94-4dea-ab16-baf590fb2f08", "id": "fc55e4e8-393f-4c71-97cf-e06d247b6744", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you have: persistent or chronic cough associated with smoking, asthma, or emphysema. cough accompanied by excessive phlegm (mucus)." ], "active_ingredient": [ "Active Ingredient (per pop) Pectin 10mg" ] }, { "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": "20120906", "purpose": [ "Active ingredients (in each teaspoonful (5 mL)) Purposes Dextromethorphan HBr USP 10 mg Cough suppressant Guaifenesin USP 100 mg Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? call 1-888-838-2872 , weekdays, 8 AM - 5 PM Eastern Time" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information each teaspoonful (5 mL) contains : sodium 3 mg store at room temperature 15°-30°C (59°-86°F)" ], "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": "3d9264e7-09d1-462a-be59-9dacd36003ba", "id": "9b2b712c-66c1-475e-8911-e1e6cc85457e", "active_ingredient": [ "Active ingredients (in each teaspoonful (5 mL)) Purposes Dextromethorphan HBr USP 10 mg Cough suppressant Guaifenesin USP 100 mg Expectorant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 teaspoonfuls every 4 hours or as directed by a doctor
children under 12 years do not use
" ], "inactive_ingredient": [ "Inactive ingredients artificial cherry flavor, citric acid, corn syrup, FD&C red #40, glycerin, menthol, purified water, sodium benzoate, sodium saccharin" ], "warnings": [ "Warnings Do not use in a child under 12 years 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 lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Guiatuss DM Dextromethorphan Hydrobromide and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE CORN SYRUP FD&C RED NO. 40 GLYCERIN MENTHOL WATER SODIUM BENZOATE SACCHARIN SODIUM DIHYDRATE reddish-pink" ], "ask_doctor": [ "Ask a doctor before use if you have a cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough 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 adults and children 12 years and over 2 teaspoonfuls every 4 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 cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use in a child under 12 years if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each teaspoonful (5 mL)) Purposes
Dextromethorphan HBr USP 10 mg Cough suppressant
Guaifenesin USP 100 mg Expectorant
" ], "package_label_principal_display_panel": [ "." ], "purpose_table": [ "
Active ingredients (in each teaspoonful (5 mL)) Purposes
Dextromethorphan HBr USP 10 mg Cough suppressant
Guaifenesin USP 100 mg Expectorant
" ] }, { "effective_time": "20120425", "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 use more than directed." ], "questions": [ "Questions? 877-434-2036" ], "storage_and_handling": [ "Other information each teaspoon contains: sodium 2 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing." ], "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": "3db4cd21-3994-442c-81a5-089b732fb2e6", "id": "33988a22-7905-4454-a0ee-6e402fd9ba5e", "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": [ "
Age (yr) Dose (mL or tsp)
tsp. = teaspoon
mL = milliliter
under 6 mos. ask a doctor
6 mos. to under 2 2.5 mL or ½ tsp.
2 to under 4 5 mL or 1 tsp.
4 to under 6 7.5 mL or 1½ tsp.
6 to under 9 10 mL or 2 tsp.
9 to under 11 12.5 mL or 2½ tsp.
11 to under 12 15 mL or 3 tsp.
or as directed by a doctor
" ], "inactive_ingredient": [ "Inactive ingredients artificial flavor, citric acid anhydrous, corn syrup, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, 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 before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. 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. 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 the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens Accudial Pain reliever/ Fever reducer Acetaminophen Acetaminophen Acetaminophen Grape Citric Acid Monohydrate Corn Syrup FD&C red no. 40 D&C red no. 33 Glycerin Cellulose, Microcrystalline Carboxymethylcellulose Sodium Propylene Glycol Water Sodium benzoate Sucralose Sorbitol Xanthan Gum" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease. Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions This product does not contain directions or complete warnings for adult use. shake well before using if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose. when weight is unknown: use the age chart on the rotating label. use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device Age (yr) Dose (mL or tsp) tsp. = teaspoon mL = milliliter under 6 mos. ask a doctor 6 mos. to under 2 2.5 mL or ½ tsp. 2 to under 4 5 mL or 1 tsp. 4 to under 6 7.5 mL or 1½ tsp. 6 to under 9 10 mL or 2 tsp. 9 to under 11 12.5 mL or 2½ tsp. 11 to under 12 15 mL or 3 tsp. or as directed by a doctor Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs." ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC. Palm Beach Gardens, FL 33408" ], "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 - 120 mL Bottle Carton Children's ACCUDIAL ® Acetaminophen Oral Suspension Pain Reliever / Fever Reducer For ages 6 mos. to under 12 yrs. or 12-95 lbs. Alcohol Free • Aspirin Free • Ibuprofen Free Compares to the active ingredient in Children's Tylenol ® Oral Suspension. ROTATING LABEL FOR WEIGHT-BASED DOSING Grape Flavor 4 FL.OZ. (120 mL) 80 mg per 1/2 teaspoon (160 mg per 5 mL) NDC 45014-136-04 Principal Display Panel" ] }, { "effective_time": "20111101", "inactive_ingredient": [ "Inactive ingredients Acesulfame Potassium, Ascorbic Acid, Cherry Flavor, Citric Acid, Corn Syrup, FD&C Red #40, Propylene Glycol, Sodium Ascorbate, Sucrose, Tartaric Acid, Water, Zinc Gluconate." ], "purpose": [ "Active ingredient (per lozenge) Purpose Dyclonine Hydrochloride 3.0 mg Oral Anesthetic/Analgesic Menthol 6.0 mg 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 Sore throat warning Severe or persistent sore throat or sore throat that occurs with or is followed by high fever, headache, rash, swelling and nausea may be serious. Ask doctor right away. Do not use more than 2 days or give to children under 2 years of age unless directed by a doctor. Ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops cough lasts more than 7 days, comes back, or occurs with fever, 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 CALL 1-800-344-7239 www.sucrets.com" ], "spl_product_data_elements": [ "Sucrets Black Cherry Dyclonine Hydrochloride DYCLONINE HYDROCHLORIDE DYCLONINE CORN SYRUP FD&C BLUE NO. 1 FD&C RED NO. 40 MENTHOL PROPYLENE GLYCOL WATER SUCROSE TARTARIC ACID TITANIUM DIOXIDE S" ], "ask_doctor": [ "Ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions adults and children 2 years of age and older: Dissolve 1 lozenge slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 2 years of age: consult a doctor or dentist." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "DIST. BY: INSIGHT PHARMACEUTICALS CORP. LANGHORNE, PA 19047-1749" ], "stop_use": [ "Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops cough lasts more than 7 days, comes back, or occurs with fever, or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other Information Avoid storing at high temperature (greater than 100°F). Use only if lozenge blister seals are unbroken" ], "active_ingredient_table": [ "
Active ingredient (per lozenge) Purpose
Dyclonine Hydrochloride 3.0 mg Oral Anesthetic/Analgesic
Menthol 6.0 mg Cough Suppressant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 24 Lozenge Container BONUS 33% MORE 24 Lozenges for the price of 18 Lozenges SUCRETS ® Dyclonine Hydrochloride • Sore Throat/Oral Anesthetic Maximum Strength SORE THROAT Made Stronger To Last Longer! ® 24 SORE THROAT LOZENGES BLACK CHERRY Principle Display Panel - 24 Lozenge Container" ], "indications_and_usage": [ "Uses temporarily relieves: occasional minor irritation, pain, sore throat and sore mouth cough associated with a cold or inhaled irritants" ], "set_id": "3ffdf9c8-26a0-4373-8e15-c4fbbad79efe", "id": "ec060aae-ffaf-48ba-a00f-c6afc6ceb96a", "purpose_table": [ "
Active ingredient (per lozenge) Purpose
Dyclonine Hydrochloride 3.0 mg Oral Anesthetic/Analgesic
Menthol 6.0 mg Cough Suppressant
" ], "active_ingredient": [ "Active ingredient (per lozenge) Purpose Dyclonine Hydrochloride 3.0 mg Oral Anesthetic/Analgesic Menthol 6.0 mg Cough Suppressant" ] }, { "effective_time": "20100617", "inactive_ingredient": [ "Inactive ingredients alcohol, carboxymethylcellulose sodium, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, polyethylene oxide, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate" ], "purpose": [ "Purpose Cough suppressant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-800-342-6844 www.vicks.com" ], "spl_product_data_elements": [ "Vicks 44 Cough Relief Dextromethorphan Hydrobromide Dextromethorphan Hydrobromide Dextromethorphan" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use dose cup, teaspoon (tsp), or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 years and over 1 TBSP (15 ml) every 6 – 8 hours children 6 to under 12 years 1½ tsp (7½ ml) every 6 – 8 hours children under 6 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each tablespoon contains sodium 28 mg store at room temperature" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label NON- DROWSY VICKS ® FORMULA 44 COUGH RELIEF Maximum Strength Cough Relief Dextromethorphan HBr...Cough Suppressant 6 FL OZ (177 ml) Alcohol 5% PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label" ], "indications_and_usage": [ "Use temporarily relieves cough due to minor throat and bronchial irritation associated with a cold" ], "set_id": "4127e5d9-a2bd-4a0c-9737-0174bad93c4f", "id": "e7e7b424-d9ba-4d6f-b5e6-8906ca4c4866", "active_ingredient": [ "Active ingredient (in each 15 ml tablespoon) Dextromethorphan HBr 30 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 TBSP (15 ml) every 6 – 8 hours
children 6 to under 12 years 1½ tsp (7½ ml) every 6 – 8 hours
children under 6 years ask a doctor
" ] }, { "effective_time": "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": "20091015", "inactive_ingredient": [ "Inactive Ingredients: Citric Acid, Corn Syrup, Echinacea Angustifolia, Echinacea Purpurea, Elderberry, Elderberry Juice Color, Fritillaria, Licorice Root, Linden Flower, Natural Flavor, Sugar, Wild Cherry Bark." ], "purpose": [ "Purpose Soothes Sore Throats" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children - beware of accidental ingestion." ], "warnings": [ "Warnings Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. Consult a physician promptly. Do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician. Ask a doctor before use if you have: Persistent or chronic cough associated with smoking, asthma, or emphysema Cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor if: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, persistent headache, rash, nausea, or vomiting. Sore mouth symptoms do not improve in 2 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children - beware of accidental ingestion." ], "questions": [ "Questions? 800-421-2998" ], "spl_product_data_elements": [ "Herbon Wild Cherry Menthol and Echinacea Menthol Menthol Echinacea Echinacea Citric Acid Monohydrate Fritillaria Sucrose Corn Syrup e Wild Cherry" ], "ask_doctor": [ "Ask a doctor before use if you have: Persistent or chronic cough associated with smoking, asthma, or emphysema Cough accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children 3 years of age and older: allow lozenge to dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a physician. Children under 3 years of age: consult a physician." ], "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: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, persistent headache, rash, nausea, or vomiting. Sore mouth symptoms do not improve in 2 days" ], "do_not_use": [ "Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. Consult a physician promptly. Do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 18 Lozenge Bag herbon ® naturally flavored wild cherry herbal throat drops Soothing & Delicious Menthol - Soothes Sore Throats 18 Drops Net Wt 2.1oz (62g) Principal Display Panel - 18 Lozenge Bag" ], "indications_and_usage": [ "Uses For the temporary relief of: Occasional minor sore throat pain, irritation and sore mouth" ], "set_id": "444743af-7833-46c5-a88d-27e76ea3f03a", "id": "e0d6456f-1308-4c97-b2c0-228534403621", "active_ingredient": [ "Active Ingredient (per drop) Menthol 2mg" ] }, { "effective_time": "20100604", "purpose": [ "Active ingredients (in each 15 ml tablespoon) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "questions": [ "Questions? 1-800-362-1683" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains sodium 19 mg store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing" ], "set_id": "446417bd-4a52-440a-923a-52ce09b9f2d2", "id": "fe195559-1472-458f-8d0a-ee085b4b64ef", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine" ], "dosage_and_administration_table": [ "
adults & children 12 yrs and over 30 ml (2 TBSP) every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD&C Blue 1, FD&C Red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate" ], "warnings": [ "Warnings Liver warning Product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hrs with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than directed dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Doxylamine succinate Doxylamine" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hrs adults & children 12 yrs and over 30 ml (2 TBSP) every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other DayQuil® or NyQuil products, carefully read each label to insure correct dosing" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202. www.vicks.com" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "active_ingredient_table": [ "
Active ingredients (in each 15 ml tablespoon) Purpose
Acetaminophen 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 295 ml Bottle Label VICKS ® NyQuil ® Cherry Flavor COLD & FLU Multi-Symptom Relief Acetaminophen…Aches, Fever Dextromethorphan…Cough Doxylamine…Sneezing, Runny Nose 10 FL OZ (295 ml) Alcohol 10% See Drug Facts Principal Display Panel - 295 ml Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 15 ml tablespoon) Purpose
Acetaminophen 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
" ], "overdosage": [ "Overdose warning Taking more than directed dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20110829", "inactive_ingredient": [ "Inactive ingredients cherry flavor, citric acid, FD and C red no. 40, glycerin, high fructose corn syrup, sucrose, sucralose, menthol, propylene glycol, purified water, xanthan gum, polysorbate, saccharin sodium, sodium benzoate" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if, cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Tussin Chest Guaifenesin GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP SUCROSE SUCRALOSE MENTHOL PROPYLENE GLYCOL WATER XANTHAN GUM POLYSORBATE 80 SACCHARIN SODIUM SODIUM BENZOATE" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "other_safety_information": [ "Other information each teaspoon contains :sodium 1mg store at 20-25°C (68-77°F) alcohol-free dosage cup provided" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than 6 doses in any 24-hour period Age Dose adults and children 12 years and over 2-4 tsp every 4 hours children 6 years to under 12 years 1-2 tsp every 4 hours children 2 years to under 6 years 1/2-1 tsp every 4 hours under 2 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if, cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "package_label_principal_display_panel": [ "Package label Tussin Chest image of carton label" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive." ], "set_id": "44deb716-d5ee-473f-bac3-9510d326224a", "id": "0d5c9dfc-7adc-499d-8da9-0ccd034826bb", "active_ingredient": [ "Active ingredients (in each 5mL tsp) Guaifenesin, USP 100mg" ], "dosage_and_administration_table": [ "
Age Dose
adults and children 12 years and over 2-4 tsp every 4 hours
children 6 years to under 12 years 1-2 tsp every 4 hours
children 2 years to under 6 years 1/2-1 tsp every 4 hours
under 2 years ask a doctor
" ] }, { "effective_time": "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": "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": "20110112", "inactive_ingredient": [ "Inactive ingredients Inactive ingredients citric acid anhydrous, D&C Red #33, edetate disodium, ethylcellulose, FD&C Blue #1, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, xanthan gum" ], "purpose": [ "Purpose Use(s) temporarily relieves • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the impulse to cough to help you get to sleep" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children" ], "warnings": [ "Warnings Warnings 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. Ask a doctor before use if you have • chronic cough that lasts 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 When using this product Stop use and ask a doctor if Stop use and ask a doctor if cough 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 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." ], "spl_product_data_elements": [ "Delsym Dextromethorphan Polistirex DEXTROMETHORPHAN DEXTROMETHORPHAN CITRIC ACID MONOHYDRATE D&C RED NO. 33 EDETATE DISODIUM ETHYLCELLULOSES FD&C BLUE NO. 1 HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYETHYLENE GLYCOL 3350 POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER SUCROSE TRAGACANTH CORN OIL XANTHAN GUM Delsym Dextromethorphan Polistirex DEXTROMETHORPHAN DEXTROMETHORPHAN CITRIC ACID MONOHYDRATE D&C RED NO. 33 EDETATE DISODIUM ETHYLCELLULOSES FD&C BLUE NO. 1 HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYETHYLENE GLYCOL 3350 POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER SUCROSE TRAGACANTH CORN OIL XANTHAN GUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Directions • shake bottle well before use • measure only with dosing cup provided. Do not use dosing cup with other products. • dose as follows or as directed by a doctor adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use Other information • each 5 mL contains: sodium 7 mg • store at 20°-25°C (68°-77°F) • dosing cup provided Drug Facts Distributed by: Reckitt Benckiser Inc., Parsippany, NJ 07054-0224 ©RBI 2009" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Delsym 30mg/ 5ml", "Package/Label Principal Display Panel Delsym 30mg/ 5ml" ], "indications_and_usage": [ "Uses Use(s) temporarily relieves • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the impulse to cough to help you get to sleep" ], "set_id": "4abb0813-e080-4bae-b829-e2c29d0a8d4f", "id": "4abb0813-e080-4bae-b829-e2c29d0a8d4f", "active_ingredient": [ "Active ingredient Dextromethorphan Polistirex" ] }, { "effective_time": "20140314", "inactive_ingredient": [ "inactive ingredients: Corn syrup, corn syrup solids, FD&C yellow #6 aluminum lake, glycerin, hydrogenated coconut oil, natural and artificial flavors, non-fat dairy milk powder, soy lecithin, and sucrose. Soybean oil and corn starch used as processing aids." ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain perscription drugs. Do not take more than 6 chews in a 34-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician." ], "questions": [ "Questions? Or to report an adverse event call 1-800-245-2898, Monday - Friday, 8AM -4PM EST" ], "spl_product_data_elements": [ "Orange Antacid Softchew Calcium Carbonate SUCROSE CALCIUM CARBONATE CALCIUM CATION" ], "other_safety_information": [ "Other information Each chew contains: calcium 470 mg, mangesium 5mg Contains milk and soy Store between 20° to 25ºC (68º to 77ºF) in a dry place" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Chew and swallow 2 to 3 chews, as symptoms occur or as directed by a physician." ], "pregnancy_or_breast_feeding": [ "If you ae pregnant or nursing a baby, ask a doctor before using this product." ], "package_label_principal_display_panel": [ "BestHealth Orange Antacid 32ct" ], "indications_and_usage": [ "Uses: relieves heartburn sour stomach acid indigestion upset stomach due to these symptoms" ], "set_id": "4be28e4b-6ccf-6b26-e054-00144ff8d46c", "id": "4be28e4b-6cd0-6b26-e054-00144ff8d46c", "active_ingredient": [ "Active ingredient (in each chew) Calcium Carbonate 1177 mg" ] }, { "effective_time": "20100617", "purpose": [ "Active ingredients (in each 15 ml tablespoon) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 200 mg Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-800-342-6844 www.vicks.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each tablespoon contains sodium 28 mg store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves cough due to the common cold helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus" ], "set_id": "4e08255e-ae1f-41e0-8ad0-212613626b5e", "id": "577adb89-748a-4f4c-b779-8b041b6bc363", "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 200 mg Expectorant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 TBSP (15 ml) every 4 hours
children 6 to under 12 years 1½ tsp (7½ ml) every 4 hours
children under 6 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, carboxymethylcellulose sodium, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, polyethylene oxide, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate" ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Vicks 44 E Cough and Chest Congestion Relief Dextromethorphan Hydrobromide and Guaifenesin Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin" ], "ask_doctor": [ "Ask a doctor before use if you have a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use dose cup, teaspoon (tsp), or tablespoon (TBSP) do not exceed 6 doses per 24 hours adults and children 12 years and over 1 TBSP (15 ml) every 4 hours children 6 to under 12 years 1½ tsp (7½ ml) every 4 hours children under 6 years ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each 15 ml tablespoon) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 200 mg Expectorant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label NON- DROWSY VICKS ® FORMULA 44 E EXPECTORANT Cough & Chest Congestion Relief Cough Suppressant...Expectorant 6 FL OZ (177 ml) Alcohol 5% PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 15 ml tablespoon) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 200 mg Expectorant
" ] }, { "effective_time": "20150113", "purpose": [ "Active ingredients (in each 5 mL) Purpose Brompheniramine Maleate 2 mg Antihistamine Pseudoephedrine HCl 30 mg Nasal Decongestant Dextromethorphan HBr 10 mg 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. 800-222-1222" ], "when_using": [ "When using this product marked drowsiness may occur do not exceed recommended dosage avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? Call 1-877-622-6836" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use" ], "storage_and_handling": [ "Other information Store at 25°C (77°F): Excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Temperature) Tamper Evident: Do not use if seal is broken or missing. Protect from freezing." ], "indications_and_usage": [ "Uses temporarily relieves runny nose sneezing itching of the nose and throat itching, watery eyes due to hay fever or other upper respiratory allergies nasal congestion due to the common cold cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep" ], "set_id": "4e81f64f-73aa-462f-86af-a1ab2a840271", "id": "d2588d5b-d6e6-4fe4-b364-6270b1ab4e05", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you or your child are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each 5 mL) Purpose Brompheniramine Maleate 2 mg Antihistamine Pseudoephedrine HCl 30 mg Nasal Decongestant Dextromethorphan HBr 10 mg Cough Suppressant" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and older 2 teaspoonsful
Children 6 to under 12 years of age 1 teaspoonful
Children 4 to under 6 years of age 1/2 teaspoonful
" ], "inactive_ingredient": [ "Inactive ingredients Alcohol Dehydrated, Butter Scotch Flavor, Citric Acid Anhydrous, FD&C Red #40, Glycerin, High Fructose Corn Syrup, Methyl Paraben, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate." ], "warnings": [ "Warnings may cause excitability, or increased irritability especially in children Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease diabetes glaucoma thyroid disease high blood pressure trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with emphysema, chronic bronchitis or asthma cough accompanied by too much phlegm (mucus) Ask a doctor or pharmacist before use if you or your child are taking sedatives or tranquilizers When using this product marked drowsiness may occur do not exceed recommended dosage avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 800-222-1222" ], "spl_product_data_elements": [ "Brom/PSE/DM Cough BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE BROMPHENIRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ALCOHOL ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP METHYLPARABEN PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease diabetes glaucoma thyroid disease high blood pressure trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with emphysema, chronic bronchitis or asthma cough accompanied by too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take every 4 hours do not take more than 4 doses in 24 hours or as directed by a doctor Adults and children 12 years of age and older 2 teaspoonsful Children 6 to under 12 years of age 1 teaspoonful Children 4 to under 6 years of age 1/2 teaspoonful Do Not Use in Children under 4 years of age" ], "package_label_principal_display_panel_table": [ "
Each 5 mL (one teaspoonful) for oral administration contains:
Brompheniramine Maleate 2 mg
Pseudoephedrine HCl 30 mg
Dextromethorphan HBr 10 mg
" ], "spl_unclassified_section": [ "Drug Facts", "Manufactured for: Macoven Pharmaceuticals, LLC Magnolia, TX 77354" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness." ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL) Purpose
Brompheniramine Maleate 2 mg Antihistamine
Pseudoephedrine HCl 30 mg Nasal Decongestant
Dextromethorphan HBr 10 mg Cough Suppressant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 44183-220-16 Brom/PSE/DM Cough Syrup ANTIHISTAMINE, NASAL DECONGESTANT, COUGH SUPPRESSANT Butter Scotch Flavor Each 5 mL (one teaspoonful) for oral administration contains: Brompheniramine Maleate 2 mg Pseudoephedrine HCl 30 mg Dextromethorphan HBr 10 mg 16 fl. oz. (473 mL) MACOVEN PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 5 mL) Purpose
Brompheniramine Maleate 2 mg Antihistamine
Pseudoephedrine HCl 30 mg Nasal Decongestant
Dextromethorphan HBr 10 mg Cough Suppressant
" ] }, { "effective_time": "20091107", "inactive_ingredient": [ "Inactive ingredients blue 1, butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, red 33, sodium benzoate, sorbitol, sucralose, xanthan gum" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children. Enter section text here" ], "warnings": [ "Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if your child takes: • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning)" ], "spl_product_data_elements": [ "Childrens Acetaminophen Oral Grape Flavor Acetaminophen ACETAMINOPHEN ACETAMINOPHEN SODIUM BENZOATE BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE GLYCERIN HIGH FRUCTOSE CORN SYRUP PROPYLENE GLYCOL SORBITOL SUCRALOSE XANTHAN GUM FD&C BLUE NO. 1 D&C RED NO. 33 WATER grape flavor" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use. • 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 more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 ask a doctor 24-35 2-3 1 teaspoon or 5 mL 36-47 4-5 1 1/2 teaspoons or 7.5 mL 48-59 6-8 2 teaspoons or 10 mL 60-71 9-10 2 1/2 teaspoons or 12.5 mL 72-95 11 3 teaspoons or 15 mL" ], "stop_use": [ "Stop use and ask a doctor if • new symptoms occur • redness or swelling is present • pain gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days These could be signs of a serious condition." ], "spl_unclassified_section": [ "Other information • store at controlled room temperature • see bottom panel for lot number and expiration date" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist" ], "package_label_principal_display_panel": [ "Principal Display Panel Children's Non-Aspirin Acetaminophen Oral Suspension Fever Reducer Pain Reliever Alcohol Free Aspirin Free Ibuprofen Free Grape Flavor 4 fl oz (118mL) image of label" ], "indications_and_usage": [ "Uses temporarily reduces fever temporarily relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache" ], "set_id": "51ceeb73-f078-4ca9-bb96-6cee33a14ad6", "id": "52b0da86-e5b6-4f33-a84a-52b969eb6b93", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin." ], "overdosage": [ "Overdose Warning Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredient Acetaminophen 160 mg" ] }, { "effective_time": "20110209", "inactive_ingredient": [ "Inactive ingredients caramel powder, citric acid, corn syrup, FD&C red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "purpose": [ "" ], "warnings": [ "Warnings Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "1-800-645-2158, 9 am – 5 pm ET, Monday – Friday" ], "spl_product_data_elements": [ "Cough Guaifenesin Guaifenesin Guaifenesin Caramel Citric Acid Monohydrate Corn Syrup FD&C RED NO. 40 Glycerin Menthol Propylene Glycol Water Sodium Benzoate Saccharin Sodium Reddish-Pink" ], "ask_doctor": [ "Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take every four hours do not take more than 6 doses in 24 hours adults and children 12 years and over 2–4 teaspoonfuls children 6 to under 12 years 1–2 teaspoonfuls children under 6 years do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each teaspoonful contains: sodium 3 mg store at room temperature 15°–30°C (59°–86°F)" ], "do_not_use": [ "TAMPER EVIDENT DO NOT USE IF INNER FOIL SEAL OVER MOUTH OF BOTTLE IS BROKEN OR MISSING" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label Rebel Distributors Corp NDC 21695-705-04 FOR ADULTS AND CHILDREN NON-NARCOTIC EXPECTORANT ALCOHOL FREE Cough SYRUP Guaifenesin, USP 4 fl oz (118 mL) Guaifenesin 100mg/5ml" ], "indications_and_usage": [ "Uses helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus" ], "set_id": "5379a585-584d-45f5-9113-dffc277d5876", "id": "5379a585-584d-45f5-9113-dffc277d5876", "active_ingredient": [ "Active ingredient (in each 5 mL teaspoonful) Guaifenesin 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2–4 teaspoonfuls
children 6 to under 12 years 1–2 teaspoonfuls
children under 6 years do not use
" ] }, { "effective_time": "20140501", "purpose": [ "Active ingredients (in each 30 mL dose cup) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine succinate 7.5 mg Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "questions": [ "Questions? 1-877-340-8824" ], "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 36 mg store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing" ], "set_id": "55f70b26-9cbf-4fe4-88fd-82d9f3ba6d77", "id": "6928f982-bbd0-432d-8950-e72aff7e8dff", "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) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine succinate 7.5 mg Antihistamine" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over 30 mL (2 TBSP) every 6 hrs
children under 12 yrs ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients citric acid, flavor, glycerin, high fructose corn syrup, honey, polyethylene glycol, propylene glycol, purified water, sodium citrate" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. 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 can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Vicks NyQuil Nature Fusion Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Doxylamine succinate Doxylamine citric acid monohydrate glycerin high fructose corn syrup honey polyethylene glycols propylene glycol water sodium citrate" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL (2 TBSP) every 6 hrs children under 12 yrs ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "active_ingredient_table": [ "
Active ingredients (in each 30 mL dose cup) Purpose
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 30 mg Cough suppressant
Doxylamine succinate 7.5 mg Antihistamine
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 236 ml Bottle Carton Relieves the Same Symptoms as NyQuil Cold & Flu VICKS ® NyQuil ® Nature Fusion ™ COLD & FLU Nighttime Relief Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr Headache, Fever, Sore Throat Minor Aches & Pains Sneezing, Runny Nose Cough FREE OF Artificial Sweetener Artificial Flavor Artificial Dye Alcohol Gluten with Real Honey 8 FL OZ (236 ml) PRINCIPAL DISPLAY PANEL - 236 ml Bottle Carton" ], "purpose_table": [ "
Active ingredients (in each 30 mL dose cup) Purpose
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 30 mg Cough suppressant
Doxylamine succinate 7.5 mg Antihistamine
" ] }, { "effective_time": "20101119", "inactive_ingredient": [ "Inactive Ingredients Corn Syrup, FD&C Blue #1, FD&C Red #40, Flavor, Glycerine, Propylene Glycol, Soy Lecithin, Sucrose, Water" ], "purpose": [ "Purpose Oral Anesthetic/Analgesic", "Purpose Oral Anesthetic/Analgesic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy Alert : Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics. Sore Throat Warning : Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor. When using this product: do not exceed recommended dosage. Stop use and ask a dentist or doctor if: sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product: do not exceed recommended dosage." ], "questions": [ "Questions? 1-800-552-7932 or www.chloraseptic.com" ], "spl_product_data_elements": [ "Chloraseptic Sore Throat Max Liquid Center Menthol and Benzocaine MENTHOL MENTHOL BENZOCAINE BENZOCAINE CORN SYRUP FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN LECITHIN, SOYBEAN SUCROSE WATER PROPYLENE GLYCOL C" ], "ask_doctor": [ "Stop use and ask a dentist or doctor if: sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth. Children under 6 years of age: Consult a doctor or dentist." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other Information Store between 59 º F and 86 º F (15 º C - 30 º C). Protect from moisture. Check expiration date before using. Tamper Evident: Do not use if blister package with “Chloraseptic ® ” name has been disturbed or opened." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Chloraseptic® Max SORE THROAT FAST ACTING RELIEF 15 lozenges | Wild Berries PRINCIPAL DISPLAY PANEL Chloraseptic® Max SORE THROAT FAST ACTING RELIEF 15 lozenges | Wild Berries" ], "indications_and_usage": [ "Uses Temporarily relieves: occasional minor irritation, pain, sore throat and sore mouth" ], "set_id": "5815a5e4-9b84-43bc-bbf3-4b85596e43d6", "id": "6c4af544-de64-4504-ae68-31b3e4d37c6d", "active_ingredient": [ "Active Ingredients (in each lozenge) Benzocaine 15 mg", "Active Ingredients (in each lozenge) Menthol 10 mg" ] }, { "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": "20100702", "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product DO NOT EXCEED RECOMMENDED DOSAGE: taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage." ], "questions": [ "Questions? For further information you may contact us at: 1-800-7-LITTLE Mon.-Fri. 8:00 a.m. to 8:00 p.m. EST, or visit us at www.LittleRemedies.com. ©2010 Dist. by: Medtech Products Inc., Irvington, NY 10533, a Prestige Brands Company Made in U.S.A. LR089101" ], "description": [ "Act ive Ingredient (in each 1.0 mL ) Acetaminophen 80mg", "Purpose Pain Reliever/Fever Reducer" ], "indications_and_usage": [ "Uses Temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache." ], "set_id": "5d3857b2-7579-44e4-84d1-24d72c0066b0", "id": "d74cce29-359d-4e1d-9555-83a342d86999", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin ." ], "dosage_and_administration_table": [ "
Weight (Ibs) Age (yrs) Dose
Under 24 Under 2 Ask a doctor
24-35 2-3 2.0 mL (1.0 mL + 1.0mL)
36-47 4-5 3.0 mL (1.0mL + 1.0 mL + 1.0mL)
" ], "inactive_ingredient": [ "Inactive Ingredients: Citric Acid, Glycerin, High Fructose Corn Syrup, Natural Flavors, PEG, Propylene Glycol, Purified Water, Sodium Benzoate and 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. 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 . Do not use: with any other products containing acetaminophen, (prescription or non-prescription). 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. Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting, consult a doctor promptly. When using this product DO NOT EXCEED RECOMMENDED DOSAGE: taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage. Stop use and ask a doctor if: new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days 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) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms. Directions This product does not contain directions or complete warnings for adult use. Shake well before using. Find the right dose on the chart below. (If possible, use weight to dose; otherwise, use age.) Only use the enclosed dropper. Do not use any other dropper, spoon or dosing device when giving this medicine to your child. Fill the enclosed dropper to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek). If needed, repeat dose every 4 hours while symptoms last. Do not give more than 5 times in any 24-hour period (see overdose warning). Replace dropper tightly to maintain child resistance. Weight (Ibs) Age (yrs) Dose Under 24 Under 2 Ask a doctor 24-35 2-3 2.0 mL (1.0 mL + 1.0mL) 36-47 4-5 3.0 mL (1.0mL + 1.0 mL + 1.0mL)" ], "spl_product_data_elements": [ "Little Fevers by Little Remedies Acetaminophen ACETAMINOPHEN ACETAMINOPHEN HIGH FRUCTOSE CORN SYRUP SODIUM BENZOATE GLYCERIN POLYETHYLENE GLYCOL PROPYLENE GLYCOL SUCRALOSE WATER ANHYDROUS CITRIC ACID" ], "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. Shake well before using. Find the right dose on the chart below. (If possible, use weight to dose; otherwise, use age.) Only use the enclosed dropper. Do not use any other dropper, spoon or dosing device when giving this medicine to your child. Fill the enclosed dropper to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek). If needed, repeat dose every 4 hours while symptoms last. Do not give more than 5 times in any 24-hour period (see overdose warning). Replace dropper tightly to maintain child resistance. Weight (Ibs) Age (yrs) Dose Under 24 Under 2 Ask a doctor 24-35 2-3 2.0 mL (1.0 mL + 1.0mL) 36-47 4-5 3.0 mL (1.0mL + 1.0 mL + 1.0mL)" ], "spl_unclassified_section": [ "Drug Facts", "Other Information Store at 20-25°C (68-77°F) Oral dosing device enclosed. Tamper Evident: This product has a foil seal under the cap. Do not use if broken or missing. Check expiration date on bottle or box before using." ], "stop_use": [ "Stop use and ask a doctor if: new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present. These could be signs of a serious condition." ], "do_not_use": [ "Do not use: with any other products containing acetaminophen, (prescription or non-prescription). 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. Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting, consult a doctor promptly." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL MEDICATED FOR INFANTS Little Fevers ® by Little Remedies® NEW! FEVER/PAIN RELIEVER Acetaminophen SAFE, GENTLE & EFFECTIVE NATURAL BERRY FLAVOR SEE NEW WARNINGS INFORMATION. 1 FL. OZ. (30 mL ) PRINCIPAL DISPLAY PANEL Little Fevers by Little Remedies 1 FL. OZ. (30mL)" ], "overdosage": [ "Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms." ], "warnings_table": [ "
Weight (Ibs) Age (yrs) Dose
Under 24 Under 2 Ask a doctor
24-35 2-3 2.0 mL (1.0 mL + 1.0mL)
36-47 4-5 3.0 mL (1.0mL + 1.0 mL + 1.0mL)
" ] }, { "effective_time": "20150731", "inactive_ingredient": [ "Inactive ingredients citric acid hydrate, D-sorbitol, FD&C red no. 40, glycerin, high fructose corn syrup, lemon essence, L-menthol, propylene glycol, purified water, sodium benzoate, sodium citrate hydrate, sucralose" ], "indications_and_usage_table": [ "
age dose
adults and children 12 years and over 10 mL every 4 hours
children under 12 years do not use
" ], "purpose": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occuring with a cold nasal congestion cough due to minor throat and bronchial irritation." ], "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 until 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." ], "when_using": [ "When using this product do not use more than directed." ], "spl_product_data_elements": [ "Family Care Multi Symptom Cold Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE SORBITOL FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP MENTHOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE" ], "ask_doctor": [ "Ask a doctor or pharmacist before us if you are taking any other oral nasal decongestant or stimulant." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Distribued by: United Exchange Corp. 17211 Valley View Ave. Cerritos, CA 90703 U.S.A Made in Korea" ], "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 10 mL contains: sodium 2 mg store at 20° to 25°C (68° to 77°F) Do not refrigerate" ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "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" ], "set_id": "5f02745f-0197-4c58-9b46-92b8aa78bf3b", "id": "afe68de8-2c7f-42aa-b7ac-612902f952d0", "active_ingredient": [ "Active ingredient (in each 10 mL) Purpose Gextromethorphan HBr, USP 20 mg.............................Cough suppressant Guaifenesin, USP 200 mg......................................................Expectorant Phenylephrine HCI, USP 10 mg....................................Nasal decongestant" ] }, { "effective_time": "20130715", "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose/carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum", "Inactive ingredients citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose/carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum" ], "purpose": [ "Purpose Fever reducer/pain reliever", "Purpose Fever reducer/pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning . Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.", "Keep out of reach of children. Overdose warning . Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 non-prescription). 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 dosage (see overdose warning) Stop use and ask a doctor if: pain gets worse or lasts for more than 5 days. fever gets worse or lasts for 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.", "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 non-prescription). 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 dosage (see overdose warning) Stop use and ask a doctor if: pain gets worse or lasts for more than 5 days. fever gets worse or lasts for 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 dosage (see overdose warning)", "When using this product do not exceed recommended dosage (see overdose warning)" ], "questions": [ "Questions or comments? 1-888-474-3099 Mon.-Fri. 8 am to 8 pm EST PediaCare.com", "Questions or comments? 1-888-474-3099 Mon.-Fri. 8 am to 8 pm EST PediaCare.com" ], "spl_product_data_elements": [ "PediaCare Single Dose Fever Reducer Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE POTASSIUM SORBATE WATER SORBITOL XANTHAN GUM SUCRALOSE PediaCare Single Dose Fever Reducer Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE POTASSIUM SORBATE WATER SORBITOL XANTHAN GUM SUCRALOSE" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease.", "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. • Each packet provides 1 dose for a child who is 48 to 59 pounds or 6 to 8 years of age. If possible, use weight to determine dose; otherwise use age. To use: • Fold back at the dotted line to reveal the tear strip. • Tear across (not up & down) at the exposed tear slit • Remove and discard strip • Squeeze medicine into child’s mouth. • If needed, repeat dose every 4 hours while symptoms last. • Do not give more than 5 times in 24 hours (see overdose warning). • Do not give more than 5 days unless directed by a doctor.", "Directions • This product does not contain directions or complete warnings for adult use. • Each packet provides 1 dose for a child who is 36 to 47 pounds or 4 to 5 years of age. If possible, use weight to determine dose; otherwise use age. To use: • Fold back at the dotted line to reveal the tear strip. • Tear across (not up & down) at the exposed tear slit • Remove and discard strip • Squeeze medicine into child’s mouth. • If needed, repeat dose every 4 hours while symptoms last. • Do not give more than 5 times in 24 hours (see overdose warning). • Do not give more than 5 days unless directed by a doctor." ], "spl_unclassified_section": [ "CHILDREN Ages 6-8 NEW! or 48-59 lbs Drug Facts", "Other information • Store at room temperature • See bottom panel for lot number and expiration date • Keep this box for future reference", "Other information • Store at room temperature • See bottom panel for lot number and expiration date • Keep this box for future reference" ], "stop_use": [ "Stop use and ask a doctor if: pain gets worse or lasts for more than 5 days. fever gets worse or lasts for more than 3 days. new symptoms occur. redness or swelling is present. These could be signs of a serious condition.", "Stop use and ask a doctor if: pain gets worse or lasts for more than 5 days. fever gets worse or lasts for 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 non-prescription). 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.", "Do not use with any other drug containing acetaminophen (prescription or non-prescription). 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 Children Ages 6-8 or 48-59 lbs PediaCare Squeezable Packet Fever Reducer Pain Reliever Acetaminophen 160mg/5mL Oral Suspension 6 Single Dose Packets 0.34 FL OZ (10 mL) EACH CHILDREN Ages 4-5 NEW! or 36-47 lbs Drug Facts Children Ages 6-8 or 48-59 lbs PediaCare Squeezable Packet Fever Reducer Pain Reliever Acetaminophen 160mg/5mL Oral Suspension 6 Single Dose Packets 0.34 FL OZ (10 mL) EACH", "PRINCIPAL DISPLAY PANEL Children Ages 4-5 or 36-47 lbs PediaCare Squeezable Packet Fever Reducer Pain Reliever Acetaminophen 160mg/5mL Oral Suspension 7 Single Dose Packets 0.25 FL OZ (7.5 mL) EACH Children Ages 4-5 or 36-47 lbs PediaCare Squeezable Packet Fever Reducer Pain Reliever Acetaminophen 160mg/5mL Oral Suspension 7 Single Dose Packets 0.25 FL OZ (7.5 mL) EACH" ], "indications_and_usage": [ "Uses: temporarily reduces fever relieves minor aches and pains due to: ○ the common cold ○ flu ○ headache ○ sore throat ○ toothache", "Uses: temporarily reduces fever relieves minor aches and pains due to: ○ the common cold ○ flu ○ headache ○ sore throat ○ toothache" ], "set_id": "6032dc92-44e5-4f32-b1a6-bba6695d2dcc", "id": "a1ba1753-d907-4172-8e06-16e7234d9d5c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.", "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 ) Acetaminophen 160 mg", "Active ingredient (in each 5 mL ) Acetaminophen 160 mg" ] }, { "effective_time": "20141028", "inactive_ingredient": [ "Inactive ingredients Carboxymethylcellulose, Flavor, Glycerin, High Fructose Corn Syrup, Methyl Paraben, Microcrystal Cellulose, Polyethylene Glycol 1450, Propyl Paraben, Propylene Glycol, Purified Water, Saccharin Sodium, Sorbitol, Sucralose, Xanthan Gum" ], "purpose": [ "Purposes Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children." ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Sore throat warning: if sore throat is severe, persist 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 non-prescription). 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 is taking the blood thinning drug warfarin. Ask a Doctor before use if your child has liver disease. When using this product do not exceed recommended dosage (see overdose warning ) Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or last more than 5 days. fever gets worse or lasts for more than 3 days. These could be signs of a serious condition. Keep this and all drugs out of reach of children. Overdose Warning Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately (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 dosage (see overdose warning )" ], "questions": [ "Questions or comments? 1-732-249-6363" ], "spl_product_data_elements": [ "Infants Pain Relief Acetaminophen Acetaminophen Acetaminophen Xanthan Gum Carboxymethylcellulose Cellulose, Microcrystalline Methylparaben Propylparaben Sucralose Saccharin Sodium Propylene Glycol Polyethylene Glycol 1450 High Fructose Corn syrup Glycerin Sorbitol Water" ], "ask_doctor": [ "Ask a doctor before use if your child is taking the blood thinning drug warfarin. 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 shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only the enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe into hole at top of bottle and turn upside down. pull back plunger of syringe until syringe filled slightly over prescribed level. Turn to original position, simply push plunger back until you have reached the prescribed level. Pull syringe out of the bottle. dispense liquid slowly into baby's mouth, toward the inner cheek. if needed repeat dose every 4 hours while symptoms last. do not use more than 5 times in 24 hours (see overdose warning ). replace cap 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 5 mL Attention: use only the enclosed syringe designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY CHAIN DRUG CONSORTIUM 3301 NW BOCA RATON BLVD SUITE 101, BOCA RATON, FL 33431" ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or last more than 5 days. fever gets worse or lasts for more than 3 days. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at controlled room temperature each 5 mL contains: sodium 2 mg" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or non-prescription). 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 - 59 mL Bottle Label NDC 68016-160-02 Premier Value ® Infants' Pain Relief PAIN RELIEVER - FEVER REDUCER ACETAMINOPHEN SUSPENSION LIQUID • Dye Free • Alcohol Free • Aspirin Free Use only with enclosed syringe Cherry Flavor INDEPENDENTLY TESTED PV SATISFACTION GUARANTEED 2 FL OZ (59 mL) Principal Display Panel - 59 mL Bottle 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": "60476951-a730-4ee6-b270-2f4ac868cfe0", "id": "991bcb88-e32d-43c9-86f9-2a9c8af5ed6a", "active_ingredient": [ "Active ingredient (in each 5 mL) Acetaminophen 160 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 5 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": "20121101", "inactive_ingredient": [ "Inactive ingredients Corn syrup, D&C yellow #10, FD&C blue #1, methyl salicylate, propylene glycol, sucrose, titanium dioxide, water" ], "purpose": [ "Purpose Oral anesthetic Oral anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor right away. Do not use more than 2 days or give to children under 12 years of age. Stop using this product and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-869-6970" ], "spl_product_data_elements": [ "Green Guard Sore Throat Relief HEXYLRESORCINOL, MENTHOL HEXYLRESORCINOL HEXYLRESORCINOL MENTHOL MENTHOL CORN SYRUP D&C YELLOW NO. 10 FD&C BLUE NO. 1 METHYL SALICYLATE PROPYLENE GLYCOL SUCROSE TITANIUM DIOXIDE WATER green OVAL N" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed Adults and children : (12 years and older) Allow 1 lozenge to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age. Other information read all warnings and directions before use. TAMPER EVIDENT: Do not use if packet is torn, ripped or shows any signs of tampering. store at room temperature 15º-30ºC (59º-86ºF) protect from moisture" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop using this product and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days" ], "package_label_principal_display_panel": [ "909B Green Guard Sore Throat Relief Label With Hexylresorcinol Sore Throat relief™ Pull to Open Hexylrescorcinol 2.4 mg Menthol 4.5 mg Hexilresorcinol 2.4 mg Mentol 4.5 mg Green Guard® 50 Lozenges Order #2213 Distributed by Green Guard®, St Louis, MO 6345 909B Green Guard Sore Throat Relief Label" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms occasional minor irritation pain sore mouth sore throat" ], "set_id": "659be1c2-fd3c-401f-bac4-fa0784999653", "id": "c7a2573a-5dd6-4161-82d1-a888051e4fd4", "active_ingredient": [ "Active ingredient (in each lozenge) Hexylrescorcinol 2.4mg Menthol 4.5mg" ] }, { "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": "20120830", "inactive_ingredient": [ "Inactive ingredients citric acid, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, xanthan gum" ], "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 chronic cough that lasts 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, 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. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-888-963-3382 You may also report side effects to this phone number." ], "spl_product_data_elements": [ "Delsym Dextromethorphan Dextromethorphan Dextromethorphan Dextromethorphan Hydrobromide Polistirex citric acid monohydrate edetate disodium ethylcelluloses FD&C Yellow No. 6 high fructose corn syrup methylparaben polyethylene glycol 3350 polysorbate 80 propylene glycol propylparaben water sucrose tragacanth xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if you have chronic cough that lasts as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions shake bottle well before use 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 of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age 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: Reckitt Benckiser, Parsippany, NJ 07054-0224 ©RB 2011 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146" ], "stop_use": [ "Stop use and ask a doctor if cough 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." ], "storage_and_handling": [ "Other information each 5 mL contains: sodium 7 mg store at 20°-25°C (68°-77°F) dosing 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": [ "PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton NDC 54868-6003-0 Delsym ® Dextromethorphan Polistirex Extended-Release Suspension (Cough Suppressant) COUGH DAY OR NIGHT 12 HOUR COUGH RELIEF Orange Flavored Liquid 89 mL (3 fl oz) Alcohol-free PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep" ], "set_id": "671b249d-60f8-450d-8888-269552339b2f", "id": "d5eac7eb-f3db-4562-a97b-f4f2117d361b", "active_ingredient": [ "Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
children under 4 years of age do not use
" ] }, { "effective_time": "20120404", "inactive_ingredient": [ "Inactive ingredients Citric Acid, Corn Syrup, FD&C Red 40, Flavor, Propylene Glycol, Purified Water, Sucrose." ], "purpose": [ "Purpose Sore Throat/Oral Anesthetic" ], "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 Stop use and ask a doctor if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting sore mouth symptoms last more than 7 days, or irritation, pain, or redness continues or worsens 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 Call 1-800-344-7239 or write to Consumer Affairs." ], "spl_product_data_elements": [ "Sucrets Childrens Cherry Dyclonine Hydrochloride DYCLONINE HYDROCHLORIDE DYCLONINE CITRIC ACID MONOHYDRATE CORN SYRUP FD&C RED NO. 40 MENTHOL PROPYLENE GLYCOL WATER SUCROSE" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions adults and children 6 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor. Do not take more than 10 lozenges per day. children under 6 years of age: ask a dentist or doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: INSIGHT Pharmaceuticals, LLC. Langhorne, PA 19047-1749" ], "stop_use": [ "Stop use and ask a doctor if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting sore mouth symptoms last more than 7 days, or irritation, pain, or redness continues or worsens" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 18 Lozenge Carton SAFETY SEALED: Do not use if foil imprinted with \"Sucrets\" is torn or missing SUCRETS ® Dyclonine Hydrochloride • Sore Throat/Oral Anesthetic Children's Formula Made Stronger To Last Longer! ® 18 SORE THROAT LOZENGES Cherry Principal Display Panel - 18 Lozenge Carton" ], "indications_and_usage": [ "Uses for the temporary relief of the following occasional mouth and throat symptoms: pain minor irritation sore mouth sore throat" ], "set_id": "68f3e4d6-4292-4c5c-96de-2c4d38ec6399", "id": "ef0a1637-58a1-4d52-a8de-5be39ae50b5f", "active_ingredient": [ "Active ingredient (per lozenge) Dyclonine Hydrochloride 1.2 mg" ] }, { "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": "20091015", "inactive_ingredient": [ "Inactive ingredients caramel powder, citric acid, corn syrup, FD&C red no. 40, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium saccharin." ], "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? 877-434-2036" ], "spl_product_data_elements": [ "Chest Congestion Guaifenesin Guaifenesin Guaifenesin Caramel Citric Acid Monohydrate Corn Syrup FD&C RED NO. 40 Glycerin Menthol Propylene Glycol Water Sodium Benzoate Saccharin Sodium Reddish-Pink" ], "ask_doctor": [ "Ask a doctor before use if 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 to find right dose, use rotating bottle label to dose by weight; otherwise, use chart at right to dose by age specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other device Age Dose children 6 years to under 12 years 5 mL to 10 mL or 1-2 teaspoonfuls every 4 hours childen 4 years to under 6 years 2.5 mL to 5 mL or 1/2-1 teaspoonful every 4 hours children under 4 years do not use" ], "spl_unclassified_section": [ "CHEST CONGESTION 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 foil seal under bottle cap is broken or missing. store between 20°-25°C (68°-77°F)" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Carton CHILDREN'S ACCU DIAL ROTATING DOSING LABEL ACCURATE DOSING BY WEIGHT Guaifenesin Oral Solution Expectorant RELIEVES Chest Congestion Thins & Loosens Mucus For Ages 4 to under 12 Alcohol Free Compares to Mucinex ® For Kids! MENTHOL FLAVOR 4 FL. OZ. (118 mL) NDC 45014-150-04 Chest Congestion Principal Display Panel - 118 mL 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": "6ab51aca-4ee8-401b-a0db-746dcde92517", "id": "f0ffa4f3-7a9c-44ed-a4c1-cba9af870345", "active_ingredient": [ "Active ingredient (in each 5 mL tsp) Guaifenesin 100 mg" ], "dosage_and_administration_table": [ "
Age Dose
children 6 years to under 12 years 5 mL to 10 mL or 1-2 teaspoonfuls every 4 hours
childen 4 years to under 6 years 2.5 mL to 5 mL or 1/2-1 teaspoonful every 4 hours
children under 4 years do not use
" ] }, { "effective_time": "20100618", "purpose": [ "Active ingredients (in each 5 ml teaspoon) Purpose Acetaminophen 162.5 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 7.5 mg Cough suppressant" ], "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 drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "questions": [ "Questions? 1-800-342-6844 www.vicks.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each teaspoon contains sodium 8 mg store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves cough/cold/flu symptoms: cough due to minor throat and bronchial irritation sneezing headache sore throat fever runny nose" ], "set_id": "6ad81e03-ff5d-4d20-9ce0-1e605e4fb3b8", "id": "cb099053-f071-46b6-9cc9-effb50e2419a", "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 teaspoon) Purpose Acetaminophen 162.5 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 7.5 mg Cough suppressant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 4 tsp (20 ml) every 6 hours
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, carboxymethylcellulose sodium, citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, polyethylene oxide, propylene glycol, purified water, saccharin sodium, sodium citrate" ], "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/fever reducers. Acetaminophen may cause liver damage. Sore throat warning If sore throat is severe, persists more than two days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use with other medicines 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 glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not use more than directed excitability may occur, especially in children drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Vicks 44 M Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide Acetaminophen Acetaminophen Chlorpheniramine maleate Chlorpheniramine Dextromethorphan Hydrobromide Dextromethorphan" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as recommended - see Overdose warning use dose cup or teaspoon (tsp) do not exceed 4 doses per 24 hours adults and children 12 years and over 4 tsp (20 ml) every 6 hours children under 12 years ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if 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 other medicines 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 5 ml teaspoon) Purpose
Acetaminophen 162.5 mg Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg Antihistamine
Dextromethorphan HBr 7.5 mg Cough suppressant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label NEW FORMULA- Pseudoephedrine Free VICKS ® FORMULA 44 M MULTI-SYMPTOM Cough, Cold & Flu Relief Maximum Strength Cough Formula Attacks coughs at the source Soothing formula Acetaminophen . . . . . . . . . . . aches, fever Chlorpheniramine . . sneezing, runny nose Dextromethorphan . . . . . . . . . . . . . .cough 8 FL OZ (236 ml) ALCOHOL 10% PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 5 ml teaspoon) Purpose
Acetaminophen 162.5 mg Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg Antihistamine
Dextromethorphan HBr 7.5 mg Cough suppressant
" ] }, { "effective_time": "20120711", "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD and C blue no.1, FD and C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose, xanthan gum" ], "purpose": [ "Purpose 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." ], "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. to make a child sleep Ask a doctor before use if you have glaucoma excessive phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness. Stop use and ask a doctor if 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 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." ], "spl_product_data_elements": [ "Night Time Cough Dextromethorphan HBr, Doxylamine succinate DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ALCOHOL CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SACCHARIN SODIUM DIHYDRATE SODIUM CITRATE SUCROSE SUCRALOSE XANTHAN GUM" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma excessive phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet" ], "other_safety_information": [ "Other information each 30mL dose cup contains : sodium 36 mg store at room temperature" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 years and over 2 TBSP (30ml) every 6 hours 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 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. to make a child sleep" ], "package_label_principal_display_panel": [ "Package label Night Time Cough Relief image of bottle label" ], "indications_and_usage": [ "Uses temporarily relieves common cold symptoms: cough runny nose and sneezing" ], "set_id": "6b83166a-470d-4e4a-a11d-27bcda37400c", "id": "fb220855-dc51-43cf-8a9b-f04ed170a667", "active_ingredient": [ "Active ingredients (in each 30 ml dose cup) Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 TBSP (30ml) every 6 hours
children under 12 years ask a doctor
" ] }, { "effective_time": "20150312", "inactive_ingredient": [ "Inactive Ingredients butylparaben, carboxymethylcellulose sodium, carrageenan, citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol" ], "purpose": [ "Purpose Pain reliever/Fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Overdose warning Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms. Do not use with any other product containing acetaminophen. Stop use and ask a doctor if • new symptoms occur • redness or swelling is present • pain gets worse or lasts for more than 5 days • fever gets worse or lasts for more than 3 days • sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting Keep out of reach of children." ], "spl_product_data_elements": [ "Childrens Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN butylparaben carboxymethylcellulose sodium carrageenan citric acid monohydrate D&C red no. 33 FD&C blue no. 1 glycerin high fructose corn syrup cellulose, microcrystalline propylene glycol water sodium benzoate sorbitol" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • Use as directed per healthcare professional. • do not use more than directed (see overdose warning ) • shake cups well before using • repeat dose every 4 hours, if needed • do not use more than 5 times in 24 hours" ], "spl_unclassified_section": [ "160 mg/5 mL 325 mg/10.15 mL 650 mg/20.3 mL Grape Flavor", "For Hospital Use Only", "Drug Facts", "Other Information • each teaspoon contains: sodium 3 mg • store at room temperature 15° - 30°C (59° - 86°F) • This product is not the same concentration as Infant's Drops. Use as directed per healthcare professional. • see individual label or shipper label for lot number and expiration date", "Alcohol Free, Aspirin Free, Ibuprofen Free", "How Supplied NDC 68094-593-58 5 mL per unit dose syringe Fifty (50) unit dose syringes per shipper NDC 68094-593-61 5 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-593-62 5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-614-62 10.15 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-650-62 20.3 mL per unit dose cup Thirty (30) cups per shipper", "Mfg. By: Perrigo 515 Eastern Avenue Allegan, MI 49010 Pkg. By: Precision Dose, Inc. 722 Progressive Lane S. Beloit, IL 61080 LI806 Rev. 02/10" ], "stop_use": [ "Stop use and ask a doctor if • new symptoms occur • redness or swelling is present • pain gets worse or lasts for more than 5 days • fever gets worse or lasts for more than 3 days • sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting" ], "do_not_use": [ "Do not use with any other product containing acetaminophen." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Children's ACETAMINOPHEN Oral Suspension 160 mg/5 mL 5 x 5 mL UNIT DOSE CUPS Bag Label" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains due to: • the common cold • flu • headaches • sore throat • immunizations • toothaches • reduces fever" ], "set_id": "6b9d50d3-0d4e-498d-9b6f-a06d2d20e9a3", "id": "24372c44-7b46-40aa-b8a0-795802ddce95", "active_ingredient": [ "Active Ingredient (in each 5 mL) Acetaminophen 160 mg" ] }, { "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": "20150504", "inactive_ingredient": [ "Inactive ingredients butylparaben, citric acid, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, hypromellose, purified water, sodium benzoate, sorbitol solution, xanthan gum" ], "purpose": [ "Purpose Pain reliever/ fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning)" ], "spl_product_data_elements": [ "Childrens QPAP acetaminophen ACETAMINOPHEN ACETAMINOPHEN BUTYLPARABEN CITRIC ACID MONOHYDRATE D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP HYPROMELLOSES WATER SODIUM BENZOATE SORBITOL XANTHAN GUM" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "openfda": {}, "version": "4", "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. 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 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 (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) Attention: Specifically designed for use with enclosed measuring cup. Use only enclosed measuring cup to dose this product. Do not use any other dosing device." ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "spl_unclassified_section": [ "Other information each 5 mL (1 tsp) contains: sodium 2 mg store at 15° to 30°C (59° to 86°F) You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.", "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev.3/15 R8 8273437 0843" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL This is an image of the carton for the Children's Q-PAP Oral Suspension Grape Flavor." ], "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": "6e1baf9e-2182-4123-a6db-0f37691160b9", "id": "0af79ad8-db5f-42c8-8922-5d42a67b4862", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin" ], "overdosage": [ "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredient (in each 5 mL = 1 tsp) Acetaminophen, USP 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 (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": "20140501", "purpose": [ "Active ingredients (in each 30 mL dose cup) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 200 mg Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-877-340-8824" ], "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 36 mg store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves cough associated with the common cold helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus" ], "set_id": "6ea0b397-3b8d-4869-b3a4-5cb72cbfb032", "id": "fd50a0fa-5085-4ca5-8197-394982d85bca", "ask_doctor_or_pharmacist": [ "If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient": [ "Active ingredients (in each 30 mL dose cup) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 200 mg Expectorant" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over 30 mL (2 TBSP) every 4 hrs
children under 12 yrs ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients citric acid, flavor, glycerin, high fructose corn syrup, honey, polyethylene glycol, propylene glycol, purified water, sodium citrate" ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) a sodium-restricted diet Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Vicks DayQuil Nature Fusion Cough and Chest Congestion Dextromethorphan Hydrobromide and Guaifenesin Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin citric acid monohydrate glycerin high fructose corn syrup honey polyethylene glycols propylene glycol water sodium citrate" ], "ask_doctor": [ "Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) a sodium-restricted diet" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions use dose cup, or tablespoon (TBSP) do not exceed 6 doses per 24 hours adults & children 12 yrs & over 30 mL (2 TBSP) every 4 hrs children under 12 yrs ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug." ], "active_ingredient_table": [ "
Active ingredients (in each 30 mL dose cup) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 200 mg Expectorant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 236 ml Bottle Carton Relieves the Same Symptoms as DayQuil Mucus Control DM VICKS ® DayQuil ® Nature Fusion™ COUGH & CHEST CONGESTION Dextromethorphan HBr, Guaifenesin Cough Suppressant Expectorant FREE OF Artificial Sweetener Artificial Flavor Artificial Dye Alcohol Gluten Non-Drowsy with Real Honey 8 FL OZ (236 ml) Principal Display Panel - 236 ml Bottle Carton" ], "purpose_table": [ "
Active ingredients (in each 30 mL dose cup) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 200 mg Expectorant
" ] }, { "effective_time": "20090731", "inactive_ingredient": [ "Inactive ingredients Citric Acid, Corn Syrup, D&C Yellow 10, Flavors, Menthol, Propylene Glycol, Purified Water, Sucrose, Titanium Dioxide." ], "purpose": [ "Purpose Sore Throat/Oral Anesthetic" ], "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 Stop use and ask a doctor if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting sore mouth symptoms last more than 7 days, or irritation, pain, or redness continues or worsens 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 Call 1-800-344-7239 or write to Consumer Affairs." ], "spl_product_data_elements": [ "Sucrets MS Wintergreen Dyclonine Hydrochloride DYCLONINE HYDROCHLORIDE DYCLONINE CITRIC ACID MONOHYDRATE CORN SYRUP D&C YELLOW NO. 10 MENTHOL PROPYLENE GLYCOL WATER SUCROSE TITANIUM DIOXIDE light green" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions adults and children 6 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor. Do not take more than 10 lozenges per day. children under 6 years of age: ask a dentist or doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749 Visit us on the web at www.insightpharma.com" ], "stop_use": [ "Stop use and ask a doctor if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting sore mouth symptoms last more than 7 days, or irritation, pain, or redness continues or worsens" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 18 Lozenges container SAFETY SEALED: Do not use if foil imprinted with \"Sucrets\" is torn or missing SUCRETS ® Dyclonine Hydrochloride • Sore Throat/Oral Anesthetic Maximum Strength SORE THROAT Made Stronger To Last Longer! ® 18 SORE THROAT LOZENGES WINTERGREEN Principle Display Panel - 18 Lozenges container" ], "indications_and_usage": [ "Uses for the temporary relief of the following occasional mouth and throat symptoms: pain minor irritation sore mouth sore throat" ], "set_id": "6fde9446-0f8d-4bba-98dc-3e3a1f170488", "id": "0683c696-2ef8-461b-9c9c-cc6bdafa951c", "active_ingredient": [ "Active ingredient (per lozenge) Dyclonine Hydrochloride 3.0 mg" ] }, { "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": "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": "20120227", "inactive_ingredient": [ "Inactive Ingredients purified water U.S.P., natural wild cherry flavor, hydroxypropyl methylcellulose, xanthan gum, sodium benzoate, glycerin, citric acid, sorbitol, high fructose corn syrup, FDandC Red No. 40" ], "purpose": [ "Purpose Pain reliever/ fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "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 Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 5 days fever gest worse or lasts for more than 3 days Keep out of reach of children. Overdose warning: Taking ore than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. quick medical attention is critical even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? Call toll free 1-800-858-3889 or www.dlclaboratories.com" ], "spl_product_data_elements": [ "De La Cruz Dolofebril Children ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN WATER XANTHAN GUM SODIUM BENZOATE GLYCERIN CITRIC ACID MONOHYDRATE SORBITOL HIGH FRUCTOSE CORN SYRUP FD&C RED NO. 40" ], "description": [ "Distributed by: De La Cruz Products A Division of DLC Laboratories, Inc. Paramount, CA 90723" ], "other_safety_information": [ "Other Information Each teaspoon contains: sodium 2mg Do not use if bottle wrap is broken or missing Store between 15-20 degreesC (59-86degreesC) see bottom panel for lot number and exipiration date." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Do not exceed recommended dose (see overdose warning) Shake well before using find right dose on chart below. If possible, use weight to dose; otherwise use age if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours only use enclosed measuring cup Dosing Table Weight (lb) Age (Years) Dose (teaspoons under 24 under 2 ask a doctor 34-35 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 Attention: Specifically designed for use with the enclosed measuring cup. Do not use any other dosing device." ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 5 days fever gest worse or lasts for more than 3 days" ], "do_not_use": [ "Do not use with any other product containing acetaminophen" ], "package_label_principal_display_panel": [ "Package Labeling Dolofebril For Pain and FEver Free of Alcohol, Aspirin and Ibuprofen Ages 2 - 11 Children's Cherry Flavor Dolofebril Childrens" ], "indications_and_usage": [ "Uses: temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat immunizations toothache" ], "set_id": "710f30d4-06a8-4eab-bde9-2f1385dec972", "id": "cee6bd40-c5de-4a31-bd06-635715c1dc21", "overdosage": [ "Overdose warning: Taking ore than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. quick medical attention is critical even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredient (in each 5mL=1 teaspoon) Acetaminophen 160mg Purpose Pain reliever/ fever reducer" ], "dosage_and_administration_table": [ "
Dosing Table
Weight (lb) Age (Years) Dose (teaspoons
under 24 under 2 ask a doctor
34-35 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
" ] }, { "effective_time": "20100507", "inactive_ingredient": [ "Inactive ingredients Corn syrup, FDC Red No. 40 lake, flavor, fructose syrup, glycerin, methylparaben, phosphoric acid, purified water." ], "purpose": [ "Uses For the relief of nausea associated with upset stomach, including that due to overindulgence in food or drink." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product do not take more than 6 does in a 24-hour period." ], "questions": [ "Questions? 1-800-792-2582" ], "spl_product_data_elements": [ "Nauzene Sodium Citrate TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID Dextrose Dextrose Fructose Fructose corn syrup FD&C Red No. 40 High fructose corn syrup Glycerin Methylparaben Phosphoric acid Water flavor" ], "ask_doctor": [ "Ask a doctor before use if you you have diabetes because this product contains sugar are on a sodium-restricted diet." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Read all package directions and warnings before use and use only as directed. Adults: 1 - 2 tablespoons (15 - 30 mL). Children: Consult a doctor for appropriate dosage. Dosage may be repeated after 30 minutes not to exceed 6 doses in a 24-hour period unless advised by a doctor. For maximum effectiveness never dilute Nauzene or drink fluids of any kind immediately before or after taking Nauzene. Nauzene Liquid is intended for use by normally healthy persons only. Persons under 18 years of age should use only as directed by a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nausea lasts more than two weeks or recurs frequently." ], "do_not_use": [ "Do not use if you have Hereditary Fructose Intolerance (HFI). This product contains fructose." ], "information_for_patients": [ "Other information Sodium content 193 mg/tablespoon (15 mL). Store at room temperature. ** Contents sealed: Each bottle of Nauzene Liquid has a tamper evident seal around the cap and a safety seal under the cap. Do not use if either of these seals appears broken. NOTE: Nauzene is not intended as a substitute for a balanced nutritional diet or as an electrolyte replenishment. Serious side effects associated with the use of this product may be reported to the phone number provided below." ], "package_label_principal_display_panel": [ "Nauzene Liquid PDP" ], "set_id": "728376f5-6cab-404e-b519-f6c595291d6f", "id": "b35b5e0f-9b2e-40ae-9db7-65f245e40844", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other medications. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each 15-mL tablespoon) Dextrose (glucose) 4.35 g...........................anti-nausea Levulose (fructose) 4.17 g...........................anti-nausea Sodium citrate dihydrate, 0.921 g................antacid" ] }, { "effective_time": "20140501", "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." ], "questions": [ "Questions? 1-877-340-8824" ], "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 36 mg store at room temperature" ], "indications_and_usage": [ "Use temporarily relieves cough due to minor throat and bronchial irritation associated with a cold" ], "set_id": "7547e98c-cf51-4df4-a9d2-4c30e2b80801", "id": "55be0d3e-f720-4e92-bae7-0798faa4b41c", "ask_doctor_or_pharmacist": [ "If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient": [ "Active ingredient (in each 30 mL dose cup) Dextromethorphan HBr 30 mg Purpose Cough suppressant" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over 30 mL (2 TBSP) every 6 - 8 hrs
children under 12 yrs ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients citric acid, flavor, glycerin, high fructose corn syrup, honey, polyethylene glycol, propylene glycol, purified water, sodium citrate" ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Vicks DayQuil Nature Fusion Cough Dextromethorphan Hydrobromide Dextromethorphan Hydrobromide Dextromethorphan citric acid monohydrate glycerin high fructose corn syrup honey polyethylene glycols propylene glycol water sodium citrate" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions use dose cup, or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults & children 12 yrs & over 30 mL (2 TBSP) every 6 - 8 hrs children under 12 yrs ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 236 ml Bottle Carton Same Powerful Symptom Relief as DayQuil Cough VICKS ® DayQuil ® Nature Fusion ™ COUGH Dextromethorphan HBr Cough Suppressant 8 HR UP TO 8 HOURS OF RELIEF FREE OF Artificial Sweetener Artificial Flavor Artificial Dye Alcohol Gluten with Real Honey Non-Drowsy 8 FL OZ (236 ml) Principal Display Panel - 236 ml Bottle Carton" ] }, { "effective_time": "20120618", "inactive_ingredient": [ "Inactive Ingredients: Corn Syrup, Echinacea Angustifolia, Echinacea Purpurea, Malic Acid, Natural Fruit Flavor Blend, Red Beet Juice Color, Sugar, Vitamin C blend (Ascorbic Acid and Sodium Ascorbate)" ], "purpose": [ "Purpose Soothes Sores Throats" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children - beware of accidental ingestion" ], "warnings": [ "Warnings Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. Consult a physician promptly. Do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician. Ask a physician before use if you have: Persistent or chronic cough associated with smoking, asthma, or emphysema. Cough accompanied by excessive phlegm (mucus). Stop use and ask a doctor if: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, persistent headache, rash, nausea, or vomiting. Sore mouth symptoms do not improve in 2 days. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children - beware of accidental ingestion" ], "questions": [ "Questions? 1.604-214-0705" ], "spl_product_data_elements": [ "Herbon Berry Buddies Pectin and Echinacea Purpurea Pectin Pectin Echinacea Purpurea Echinacea Purpurea Sucrose Corn Syrup Malic Acid Ascorbic Acid Sodium Ascorbate Dark pink lollipop with white stick" ], "ask_doctor": [ "Ask a physician before use if you have: Persistent or chronic cough associated with smoking, asthma, or emphysema. Cough accompanied by excessive phlegm (mucus)." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children 3 years of age and older: allow Goodypop to dissolve slowly in the mouth. May be repeated as needed or as directed by a physician. Children under 3 years of age: consult a physician." ], "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: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, persistent headache, rash, nausea, or vomiting. Sore mouth symptoms do not improve in 2 days." ], "do_not_use": [ "Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. Consult a physician promptly. Do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 8 Lozenge Bag herbon ® kids Soothing & Delicious Sore Throat Relief BerryBuddies 8 GOODYPOPS Field Berry Flavor with Pectin Net Wt 2.3oz (65g) Principal Display Panel - 8 Lozenge Bag" ], "indications_and_usage": [ "Uses For the temporary relief of: Occasional minor sore throat pain, irritation and sore mouth." ], "set_id": "79955b96-8f8c-49bb-a415-88a9cbeae633", "id": "bc057a83-5e85-4a11-9664-528403279009", "active_ingredient": [ "Active Ingredient (per pop) Pectin 10mg" ] }, { "effective_time": "20141028", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage (see overdose warning )" ], "questions": [ "Questions or comments? 1-732-249-6363" ], "storage_and_handling": [ "Other information store at controlled room temperature dosage cup provided each teaspoon contains: sodium 2 mg" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache" ], "set_id": "79d06662-1677-4032-bf55-314af0f68d15", "id": "fb03bf24-dbff-419e-82c7-04e1917b5208", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the 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 ask a doctor
24-35 2-3 1 tsp or 5 mL
36-47 4-5 1½ tsps or 7.5 mL
48-59 6-8 2 tsps or 10 mL
60-71 9-10 2½ tsps or 12.5 mL
72-95 11 3 tsps or 15 mL
" ], "inactive_ingredient": [ "Inactive ingredients Carboxymethylcellulose, D & C Red # 33, FD & C Red # 40, Flavors, Glycerin, High Fructose Corn Syrup, Methylparaben, Microcrystalline Cellulose, Polyethylene Glycol 1450, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sorbitol Solution, Sucralose Powder, 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 non-prescription). 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 the child is taking the blood thinning drug warfarin When using this product do not exceed recommended dosage (see overdose warning ) Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts for more than 3 days. These could be signs of a serious condition. Keep this and all drugs out of the reach of children. Overdose Warning Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens Pain Relief Acetaminophen Acetaminophen Acetaminophen Xanthan Gum Carboxymethylcellulose Cellulose, Microcrystalline Methylparaben Propylparaben Sucralose Saccharin Sodium Propylene Glycol Polyethylene Glycol 1450 High Fructose Corn Syrup Glycerin Sorbitol D&C Red No. 33 FD&C Red No. 40 Water" ], "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 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 tsp = teaspoon, mL = milliliter if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 ask a doctor 24-35 2-3 1 tsp or 5 mL 36-47 4-5 1½ tsps or 7.5 mL 48-59 6-8 2 tsps or 10 mL 60-71 9-10 2½ tsps or 12.5 mL 72-95 11 3 tsps or 15 mL" ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY CHAIN DRUG CONSORTIUM 3301 NW BOCA RATON BLVD SUITE 101, BOCA RATON, FL 33431" ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts for more than 3 days. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or non-prescription). 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 - 118 mL Bottle Label NDC 68016-178-04 Premier Value ® Children's Pain Relief PAIN RELIEVER - FEVER REDUCER ACETAMINOPHEN SUSPENSION LIQUID • Alcohol Free • Aspirin Free • Ibuprofen Free Bubble Gum Flavor 4 FL OZ (118 mL) INDEPENDENTLY TESTED PV SATISFACTION GUARANTEED Principal Display Panel - 118 mL Bottle Label" ] }, { "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": "20100119", "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." ], "questions": [ "Questions? 877-434-2036" ], "storage_and_handling": [ "Storage & Package Safety do not use if inner foil seal is broken or missing store between 20°-25°C (68°-77°F) 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 headache sore throat toothache temporarily reduces fever" ], "set_id": "7eb3f185-6b4a-4674-8658-79132b1f6aec", "id": "c9eb1f5c-6b5a-4ba5-932f-412a2fa463a1", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the 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": [ "
Age (yr) Dose (mL or tsp)
under 2 years ask a doctor
2-3 years 5 mL or 1 tsp.
4-5 years 7.5 mL or 1½ tsp.
6-8 years 10 mL or 2 tsp.
9-10 years 12.5 mL or 2½ tsp.
11 years 15 mL or 3 tsp.
" ], "inactive_ingredient": [ "Inactive ingredients artificial flavor, citric acid, corn syrup, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethyl cellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol, 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. Ask a doctor before use if the child has liver disease. Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin. When using this product Do not exceed recommended dose. 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 the 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": [ "Pain and Fever Acetaminophen Acetaminophen Acetaminophen Cherry Citric Acid Monohydrate Corn Syrup FD&C RED NO. 40 Glycerin Cellulose, Microcrystalline CarboxymethylCellulose Sodium Propylene Glycol Water Sodium benzoate Sucralose Sorbitol Xanthan Gum" ], "ask_doctor": [ "Ask a doctor before use if the child has liver disease." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions shake well before using if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device Age (yr) Dose (mL or tsp) under 2 years ask a doctor 2-3 years 5 mL or 1 tsp. 4-5 years 7.5 mL or 1½ tsp. 6-8 years 10 mL or 2 tsp. 9-10 years 12.5 mL or 2½ tsp. 11 years 15 mL or 3 tsp." ], "spl_unclassified_section": [ "Drug Facts", "Other information each teaspoon contains: sodium 2 mg" ], "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." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 120 mL Carton CHILDREN'S ACCU DIAL ROTATING DOSING LABEL ACCURATE DOSING BY WEIGHT CONTAINS Acetaminophen Oral Suspension Pain Reliever, Fever Reducer For Ages 2 to under 12 Alcohol Free • Aspirin Free • Ibuprofen Free 80 mg per 1/2 teaspoon (160 mg per 5 mL) CHERRY FLAVOR Compares to Children's Tylenol ® . 4 FL.OZ. (120 mL) NDC 45014-131-04 Principal Display Panel - 120 mL Carton" ] }, { "effective_time": "20121226", "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." ], "when_using": [ "When using this product do not use more than directed. Taking more than recommended may cause drowsiness." ], "questions": [ "Questions or comments? call weekdays from 9 AM to 5 PM EST at 1-800-ALAVERT (1-800-252-8378)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information Phenylketonurics : Contains Phenylalanine 8.4 mg per tablet store at 20-25°C (68-77°F) keep in a dry place" ], "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": "7f4ecbce-74f7-4dfe-8c7d-7703458fdbb1", "id": "d8fd80c9-b8a2-4427-8636-6db06d0fc2ee", "active_ingredient": [ "Active ingredient (in each tablet) Loratadine 10 mg" ], "dosage_and_administration_table": [ "
Age Dose
adults and children 6 years and over 1 tablet daily, do not use more than 1 tablet daily
children under 6 ask a doctor
consumers who have liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients artificial & natural flavor, aspartame, citric acid, colloidal silicon dioxide, corn syrup solids, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, modified food starch, sodium bicarbonate" ], "warnings": [ "Warnings Do not use 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 or kidney disease. Your doctor should determine if you need a different dose. When using this product do not use more than directed. Taking more than recommended may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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": [ "Alavert Allergy Loratadine Loratadine Loratadine off white beveled A;24" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions tablet melts in mouth. Can be taken with or without water Age Dose adults and children 6 years and over 1 tablet daily, do not use more than 1 tablet daily children under 6 ask a doctor consumers who have liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Wyeth Consumer Healthcare, Madison, NJ 07940 ©2006 www.alavert.com" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 1 Tablet Carton MELTS IN YOUR MOUTH! Same Fresh Mint Flavor! allergy ALAVERT ® Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine Non-Drowsy* Allergy Relief 24 HOUR Relief of Sneezing Runny Nose Itchy, Watery Eyes Itching of Nose & Throat Original Flavor 1 Orally Disintegrating Tablet *When taken as directed. See Drug Facts Panel. 1 Orally Disintegrating TABLET THE ORIGINAL Lil' Drug Store ® PRINCIPAL DISPLAY PANEL - 1 Tablet Carton" ] }, { "effective_time": "20150415", "purpose": [ "Active ingredients (in each lozenge) Purpose Benzocaine 7.5 mg Oral pain reliever Dextromethorphan hydrobromide 5 mg Cough suppressant" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Do not exceed recommended dosage." ], "questions": [ "Questions? Call 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 tamper evident: product is sealed in blister package for your protection. Do not use if carton or blister package has been disturbed or opened. store at room temperature 20-25°C (68-77°F) protect contents from humidity" ], "indications_and_usage": [ "Uses temporarily relieves sore throat sore mouth minor mouth irritation pain associated with canker sores cough due to minor throat and bronchial irritation as may occur with the common cold" ], "set_id": "7f5f3517-1091-40fd-a402-ebcfa803922b", "id": "d7c356e2-17c9-46a1-adf7-5882823488cc", "active_ingredient": [ "Active ingredients (in each lozenge) Purpose Benzocaine 7.5 mg Oral pain reliever Dextromethorphan hydrobromide 5 mg Cough suppressant" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, cetylpyridinium chloride, corn syrup, FD&C blue #1, FD&C red #40, flavors, propylene glycol, purified water, sodium bicarbonate, sucrose" ], "warnings": [ "Warnings Allergy alert Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics. 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 6 years of age. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that is accompanied by excessive phlegm (mucus) Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling develops cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage." ], "spl_product_data_elements": [ "Cepacol Sore Throat and Cough Benzocaine and Dextromethorphan Hydrobromide Benzocaine Benzocaine Dextromethorphan Hydrobromide Dextromethorphan acesulfame potassium cetylpyridinium chloride FD&C blue NO. 1 FD&C red NO. 40 dextrose propylene glycol water sodium bicarbonate sucrose corn syrup C" ], "ask_doctor": [ "Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that is accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor children under 6 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 or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling develops 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 under 6 years of age. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each lozenge) Purpose
Benzocaine 7.5 mg Oral pain reliever
Dextromethorphan hydrobromide 5 mg Cough suppressant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton NDC 63824-740-16 NEW PACK, SAME RELIEF! Cēpacol ® SORE THROAT & COUGH Benzocaine 7.5 mg | Dextromethorphan HBr 5 mg Oral Pain Reliever | Cough Suppressant • Instant Acting • Maximum Strength Numbing 16 Lozenges mixed berry Principal Display Panel - 16 Lozenge Carton" ], "purpose_table": [ "
Active ingredients (in each lozenge) Purpose
Benzocaine 7.5 mg Oral pain reliever
Dextromethorphan hydrobromide 5 mg Cough suppressant
" ] }, { "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": "20130313", "purpose": [ "Active ingredients (in each chewable tablet) Purpose Famotidine 10 mg Acid reducer Calcium carbonate 800 mg Antacid Magnesium hydroxide 165 mg Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-570-8650" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each tablet contains: calcium 320 mg; magnesium 70 mg read the directions and warnings before use keep the carton. It contains important information. store at 20°-30°C (68°- 86 ° F) protect from moisture" ], "indications_and_usage": [ "Use relieves heartburn associated with acid indigestion and sour stomach" ], "set_id": "823da444-1664-47d1-bf0a-2794eb1cc9b5", "id": "eae62b07-b2c1-4737-851e-5845b24225dd", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each chewable tablet) Purpose Famotidine 10 mg Acid reducer Calcium carbonate 800 mg Antacid Magnesium hydroxide 165 mg Antacid" ], "inactive_ingredient": [ "Inactive ingredients cellulose acetate, corn starch, corn syrup solids, crospovidone, dextrose, FD&C yellow #5 aluminum lake (tartrazine), FD&C yellow #6 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, maltodextrin, mineral oil, sucralose, triacetin" ], "warnings": [ "Warnings Allergy alert Do not use if you are allergic to famotidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "ConRx Acid Reducer Famotidine, Calcium carbonate, and Magnesium Hydroxide Famotidine Famotidine Calcium carbonate Calcium Cation Magnesium Hydroxide Magnesium Cation CELLULOSE ACETATE CORN SYRUP STARCH, CORN CROSPOVIDONE DEXTROSE FD&C YELLOW NO. 5 ALUMINUM OXIDE FD&C YELLOW NO. 6 ACACIA HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES LACTOSE MAGNESIUM STEARATE MALTODEXTRIN MINERAL OIL SUCRALOSE TRIACETIN CRX" ], "ask_doctor": [ "Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years and over: do not swallow tablet whole: chew completely to relieve symptoms, do not use more than 2 chewable tablets in 24 hours children under 12 years: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers" ], "active_ingredient_table": [ "
Active ingredients (in each chewable tablet) Purpose
Famotidine 10 mg Acid reducer
Calcium carbonate 800 mg Antacid
Magnesium hydroxide 165 mg Antacid
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 25 Pouch Box Compare to the Active Ingredients in Pepcid Complete ® * 1 Tablet Relieves Heartburn ConRx™ AR Acid Reducer Antacid Tropical Fruit Flavor Chewable Tablet TO OPEN PUSH IN TAB AND PULL OUT Compare to the Active Ingredients in Pepcid Complete ® * 25 Pouches of 1 Tablets Each PRINCIPAL DISPLAY PANEL - 25 Pouch Box" ], "purpose_table": [ "
Active ingredients (in each chewable tablet) Purpose
Famotidine 10 mg Acid reducer
Calcium carbonate 800 mg Antacid
Magnesium hydroxide 165 mg Antacid
" ] }, { "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": "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": "20130215", "purpose": [ "PURPOSE In Pediatric Patients , : For reduction of fever in patients aged 6 months up to 2 years of age. For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. For relief of signs and symptoms of juvenile arthritis. In Adults , : For treatment of primary dysmenorrhea. For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis." ], "precautions": [ "PRECAUTIONS General Ibuprofen suspension cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of ibuprofen suspension in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. Hepatic Effects Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including ibuprofen suspension. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with ibuprofen suspension. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), ibuprofen suspension should be discontinued. Hematological Effects Anemia is sometimes seen in patients receiving NSAIDs, including ibuprofen suspension. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including ibuprofen suspension, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia. In two postmarketing clinical studies the incidence of a decreased hemoglobin level was greater than previously reported. Decrease in hemoglobin of 1 gram or more was observed in 17.1% of 193 patients on 1600 mg ibuprofen daily (osteoarthritis), and in 22.8% of 189 patients taking 2400 mg of ibuprofen daily (rheumatoid arthritis). Positive stool occult blood tests and elevated serum creatinine levels were also observed in these studies. NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving ibuprofen suspension who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored. Preexisting Asthma Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, ibuprofen suspension should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma. Aseptic Meningitis Aseptic meningitis, with fever and coma, has been observed on rare occasions in patients on ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease. Diabetics Ibuprofen suspension contains 270 mg high fructose corn syrup and 2.43 calories per mL, or 1350 mg high fructose corn syrup and 12.15 calories per teaspoonful, which should be taken into consideration when treating diabetic patients with this product. Information for Patients Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. Ibuprofen suspension, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization, and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS - Cardiovascular Effects ). Ibuprofen suspension, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization or even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS - Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation ). Ibuprofen suspension, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash or contact their physicians as soon as possible. Patients should promptly report signs and symptoms of unexplained weight gain or edema to their physicians. Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritis, jaundice, right upper quadrant tenderness, and \"flu-like\" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy. Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS ). In late pregnancy, as with other NSAIDs, ibuprofen suspension should be avoided because it may cause premature closure of the ductus arteriosus. Laboratory Tests Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, ibuprofen suspension should be discontinued. Drug Interactions ACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. Aspirin As with other NSAIDs, concomitant administration of IBUPROFEN and aspirin is not generally recommended because of the potential of increased adverse effects. Diuretics Clinical studies, as well as post marketing observations, have shown that ibuprofen suspension can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS - Renal Effects ), as well as to assure diuretic efficacy. Lithium Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.) Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate. Warfarin Several short-term controlled studies failed to show that ibuprofen significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on warfarin-type anticoagulants. However, because bleeding has been reported when ibuprofen and other NSAIDs have been administered to patients on warfarin-type anticoagulants, the physician should be cautious when administering ibuprofen to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. Pregnancy Teratogenic Effects Pregnancy Category C Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Ibuprofen should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided. Labor and Delivery In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of ibuprofen suspension on labor and delivery in pregnant women are unknown. Therefore, administration of ibuprofen suspension is not recommended during labor and delivery. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ibuprofen suspension, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness of ibuprofen suspension in pediatric patients below the age of 6 months have not been established (see CLINICAL PHARMACOLOGY - Clinical Studies ). Dosing of ibuprofen suspension in children 6 months or older should be guided by their body weight (see DOSAGE AND ADMINISTRATION ). Geriatric Use As with any NSAID, caution should be exercised in treating the elderly (65 years and older)." ], "keep_out_of_reach_of_children": [ "Enter section text here" ], "clinical_pharmacology_table": [ "
Table 1 Pharmacokinetic Parameters of Ibuprofen Suspension [Mean values (% coefficient of variation)]
Dose 200mg (2.8mg/kg) in Adults 10mg/kg in Febrile Children
Formulation Suspension Suspension
Number of Patients 24 18
AUCinf (µg•h/mL) 64 (27%) 155 (24%)
Cmax (µg/mL) 19 (22%) 55 (23%)
Tmax (h) 0.79 (69%) 0.97 (57%)
CI/F(mL/h/kg) 45.6 (22%) 68.6 (22%)
" ], "indications_and_usage": [ "INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen suspension and other treatment options before deciding to use ibuprofen suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). In Pediatric Patients , ibuprofen suspension is indicated: For reduction of fever in patients aged 6 months up to 2 years of age. For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. For relief of signs and symptoms of juvenile arthritis. In Adults , ibuprofen is indicated: For treatment of primary dysmenorrhea. For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended. (See PRECAUTIONS - Drug Interactions )." ], "set_id": "84c2b3e4-366c-433e-8a5e-14d606c5201e", "id": "f9091453-e7e9-4b6c-9f53-c5c0c4417261", "active_ingredient": [ "DESCRIPTION The active ingredient in ibuprofen suspension is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 74° to 77°C. It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is C 13 H 18 0 2 and it has the following structural formula: Ibuprofen suspension is a sweetened, orange colored, berry flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). image of chemical structure" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Inactive ingredients include: butylparaben, citric acid, corn syrup, D&C red #33, FD&C yellow #6, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum." ], "contraindications": [ "CONTRAINDICATIONS Ibuprofen suspension is contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen suspension should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDS have been reported in such patients (see WARNINGS - Anaphylactoid Reactions and PRECAUTIONS - Preexisting Asthma ). Ibuprofen suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS )." ], "warnings": [ "WARNINGS CARDIOVASCULAR EFFECTS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS ). Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS ). Hypertension NSAIDs, including ibuprofen suspension, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ibuprofen suspension, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Congestive Heart Failure and Edema Fluid retention and edema have been observed in some patients taking NSAIDs. Ibuprofen suspension should be used with caution in patients with fluid retention or heart failure. Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation NSAIDs, including ibuprofen suspension, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered. Renal Effects Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. Advanced Renal Disease No information is available from controlled clinical studies regarding the use of ibuprofen suspension in patients with advanced renal disease. Therefore, treatment with ibuprofen suspension is not recommended in these patients with advanced renal disease. If ibuprofen suspension therapy must be initiated, close monitoring of the patient's renal function is advisable. Anaphylactoid Reactions As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to ibuprofen suspension. Ibuprofen suspension should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS – Preexisting Asthma ). Emergency help should be sought in cases where an anaphylactoid reaction occurs. Skin Reactions NSAIDs, including ibuprofen suspension, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Pregnancy In late pregnancy, as with other NSAIDs, ibuprofen should be avoided because it may cause premature closure of the ductus arteriosus." ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN BUTYLPARABEN CITRIC ACID MONOHYDRATE CORN SYRUP D&C RED NO. 33 FD&C YELLOW NO. 6 HYPROMELLOSES POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL XANTHAN GUM GLYCERIN" ], "boxed_warning": [ "R x Only Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS ). Ibuprofen suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS )." ], "adverse_reactions_table": [ "
Body as a whole - fever, infection, sepsis
Cardiovascular system - congestive heart failure in patients with marginal cardiac function, hypertension, tachycardia, syncope
Digestive system - dry mouth, duodenitits, esophagitis, gastric or duodenal ulcer with bleeding and/or perforation, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding
Hemic and lymphatic system - ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, thrombocytopenia
Metabolic and nutritional - weight changes
Nervous system - anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, vertigo
Respiratory system - asthma, dyspnea
Skin and appendages - alopecia, photosensitivity, sweat
Special senses - blurred vision
Urogenital system - cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, acute renal failure in patients with pre-existing significantly impaired renal function
", "
Body as a whole - anaphylactic reactions, anaphylactoid reactions, appetite changes
Cardiovascular system - arrhythmia, cerebrovascular accident, hypotension, myocardial infarction, palpitations, vasculitis
Digestive system - eructation, gingival ulcer, hepatorenal syndrome, liver necrosis, liver failure, pancreatitis
Hemic and lymphatic system - agranulocystosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, pancytopenia
Metabolic and nutritional - hyperglycemia
Nervous system - convulsions, coma, emotional lability, hallucinations, aseptic meningitis
Respiratory - apnea, respiratory depression, pneumonia, rhinitis
Skin and appendages - angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens Johnson syndrome, urticaria, vesiculobullous eruptions
Special senses - amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision), conjunctivitis, dry eyes, hearing impairment
Urogenital - azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, tubular necrosis
" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of ibuprofen suspension and other treatment options before deciding to use ibuprofen suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with ibuprofen suspension, the dose and frequency should be adjusted to suit an individual patient's needs. PEDIATRIC PATIENTS Fever reduction For reduction of fever in children, 6 months up to 2 years of age, the dosage should be adjusted on the basis of the initial temperature level (see CLINICAL PHARMACOLOGY ). The recommended dose is 5 mg/kg if the baseline temperature is less than 102.5°F, or 10 mg/kg if the baseline temperature is 102.5°F or greater. The duration of fever reduction is generally 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg. Analgesia For relief of mild to moderate pain in children 6 months up to 2 years of age, the recommended dosage is 10 mg/kg, every 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg. Doses should be given so as not to disturb the child's sleep pattern. Juvenile Arthritis The recommended dose is 30 to 40 mg/kg/day divided into three to four doses (see Individualization of Dosage ). Patients with milder disease may be adequately treated with 20 mg/kg/day. In patients with juvenile arthritis, doses above 50 mg/kg/day are not recommended because they have not been studied and doses exceeding the upper recommended dose of 40 mg/kg/day may increase the risk of causing serious adverse events. The therapeutic response may require from a few days to several weeks to be achieved. Once a clinical effect is obtained, the dosage should be lowered to the smallest dose of ibuprofen needed to maintain adequate control of symptoms. Pediatric patients receiving doses above 30 mg/kg/day or if abnormal liver function tests have occurred with previous NSAID treatments should be carefully followed for signs and symptoms of early liver dysfunction. ADULTS Primary Dysmenorrhea For the treatment of primary dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen suspension should be given in a dose of 400 mg every 4 hours, as necessary, for the relief of pain. Rheumatoid arthritis and osteoarthritis Suggested dosage: 1200-3200 mg daily (300 mg q.i.d. or 400 mg, 600 mg or 800 mg t.i.d. or q.i.d.). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk. Individualization of Dosage The dose of ibuprofen suspension should be tailored to each patient, and may be lowered or raised from the suggested doses depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond. One fever study showed that, after the initial dose of ibuprofen suspension, subsequent doses may be lowered and still provide adequate fever control. In a situation when low fever would require the ibuprofen suspension 5 mg/kg dose in a child with pain, the dose that will effectively treat the predominant symptom should be chosen. In chronic conditions, a therapeutic response to ibuprofen suspension therapy is sometimes seen in a few days to a week, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required. Patients with rheumatoid arthritis seem to require higher doses than do patients with osteoarthritis. The smallest dose of ibuprofen suspension that yields acceptable control should be employed. Ibuprofen suspension may be used in combination with gold salts and/or corticosteroids." ], "adverse_reactions": [ "ADVERSE REACTIONS In patients taking ibuprofen or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are: Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, fluid retention, gastrointestinal experiences (including abdominal pain, bloating, constipation, diarrhea, dyspepsia, epigastric pain, flatulence, heartburn, nausea, vomiting), headaches, increased bleeding time, nervousness, pruritus, rashes (including maculopapular) and tinnitus. Additional adverse experiences reported occasionally include: Body as a whole - fever, infection, sepsis Cardiovascular system - congestive heart failure in patients with marginal cardiac function, hypertension, tachycardia, syncope Digestive system - dry mouth, duodenitits, esophagitis, gastric or duodenal ulcer with bleeding and/or perforation, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding Hemic and lymphatic system - ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, thrombocytopenia Metabolic and nutritional - weight changes Nervous system - anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, vertigo Respiratory system - asthma, dyspnea Skin and appendages - alopecia, photosensitivity, sweat Special senses - blurred vision Urogenital system - cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, acute renal failure in patients with pre-existing significantly impaired renal function Other adverse reactions, which occur rarely are: Body as a whole - anaphylactic reactions, anaphylactoid reactions, appetite changes Cardiovascular system - arrhythmia, cerebrovascular accident, hypotension, myocardial infarction, palpitations, vasculitis Digestive system - eructation, gingival ulcer, hepatorenal syndrome, liver necrosis, liver failure, pancreatitis Hemic and lymphatic system - agranulocystosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, pancytopenia Metabolic and nutritional - hyperglycemia Nervous system - convulsions, coma, emotional lability, hallucinations, aseptic meningitis Respiratory - apnea, respiratory depression, pneumonia, rhinitis Skin and appendages - angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens Johnson syndrome, urticaria, vesiculobullous eruptions Special senses - amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision), conjunctivitis, dry eyes, hearing impairment Urogenital - azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, tubular necrosis" ], "how_supplied": [ "HOW SUPPLIED/STORAGE AND HANDLING Ibuprofen Suspension, 100 mg/5 mL is available as follows: Orange-colored, berry-flavored suspension Bottles of 120 mL - NDC 54868-4342-0 Shake well before using. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. MANUFACTURED AND DISTRIBUTED BY PERRIGO ® ALLEGAN, MI 49010 Revised 07/08 Relabeling of \"Additional Barcode Label\" by: Physicians Total Care, Inc. Tulsa, OK 74146" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Ibuprofen Suspension, 100 mg/5 mL 120 mL image of package label" ], "spl_medguide": [ "Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAlDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: with longer use of NSAID medicines in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a \"coronary artery bypass graft (CABG).\" NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: can happen without warning symptoms may cause death The chance of a person getting an ulcer or bleeding increases with: taking medicines called \"corticosteroids\" and \"anticoagulants\" longer use smoking drinking alcohol older age having poor health NSAID medicines should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: different types of arthritis menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine for pain right before or after heart bypass surgery Tell your healthcare provider: about all your medical conditions. about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy. if you are breastfeeding. Talk to your doctor. What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Serious side effects include: Other side effects include: heart attack stroke high blood pressure heart failure from body swelling (fluid retention) kidney problems including kidney failure bleeding and ulcers in the stomach and intestine low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions liver problems including liver failure asthma attacks in people who have asthma stomach pain constipation diarrhea gas heartburn nausea vomiting dizziness Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing chest pain weakness in one part or side of your body slurred speech swelling of the face or throat Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: nausea more tired or weaker than usual itching your skin or eyes look yellow stomach pain flu-like symptoms vomit blood there is blood in your bowel movement or it is black and sticky like tar unusual weight gain skin rash or blisters with fever swelling of the arms and legs, hands and feet These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines. Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days. NSAID medicines that need a prescription Generic Name Tradename Celecoxib Celebrex Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol) Diflunisal Dolobid Etodolac Lodine, Lodine XL Fenoprofen Nalfon, Nalfon 200 Flurbiprofen Ansaid Ibuprofen Motrin, Tab-Profen, Vicoprofen * (combined with hydrocodone), Combunox (combined with oxycodone) Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan Ketoprofen Oruvail Ketorolac Toradol Mefenamic Acid Ponstel Meloxicam Mobic Nabumetone Relafen Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, NapraPAC (copackaged with lansoprazole) Oxaprozin Daypro Piroxicam Feldene Sulindac Clinoril Tolmetin Tolectin, Tolectin DS, Tolectin 600 * Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC label warns that long term continuous use may increase the risk of heart attack or stroke. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This Medication Guide has been approved by the U.S. Food and Drug Administration." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Pharmacodynamics Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that possesses anti-inflammatory, analgesic and antipyretic activity. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition. After absorption of the racemic ibuprofen, the [-]R-enantiomer undergoes interconversion to the [+]S-form. The biological activities of ibuprofen are associated with the [+]S-enantiomer. Pharmacokinetics Ibuprofen is a racemic mixture of [-]R-and [+]S-isomers. In vivo and in vitro studies indicate that the [+]S-isomer is responsible for clinical activity. The [-]R-form, while thought to be pharmacologically inactive, is slowly and incompletely (~60%) interconverted into the active [+]S species in adults. The degree of interconversion in children is unknown, but is thought to be similar. The [-]R-isomer serves as a circulating reservoir to maintain levels of active drug. Ibuprofen is well absorbed orally, with less than 1% being excreted in the urine unchanged. It has a biphasic elimination time curve with a plasma half-life of approximately 2 hours. Studies in febrile children have established the dose-proportionality of 5 and 10 mg/kg doses of ibuprofen. Studies in adults have established the dose-proportionality of ibuprofen as a single oral dose from 50 to 600 mg for total drug and up to 1200 mg for free drug. Absorption In vivo studies indicate that ibuprofen is well absorbed orally from the suspension formulation, with peak plasma levels usually occurring within 1 to 2 hours (see Table 1 ). Table 1 Pharmacokinetic Parameters of Ibuprofen Suspension [Mean values (% coefficient of variation)] Dose 200mg (2.8mg/kg) in Adults 10mg/kg in Febrile Children Formulation Suspension Suspension Number of Patients 24 18 AUCinf (µg•h/mL) 64 (27%) 155 (24%) Cmax (µg/mL) 19 (22%) 55 (23%) Tmax (h) 0.79 (69%) 0.97 (57%) CI/F(mL/h/kg) 45.6 (22%) 68.6 (22%) Legend: AUCinf = Area-under-the-curve to infinity Tmax = Time-to-peak plasma concentration Cmax = Peak plasma concentration CI/F = Clearence divided by fraction at drug absorbed Antacids A bioavailability study in adults has shown that there was no interference with the absorption of ibuprofen when given in conjunction with an antacid containing both aluminum hydroxide and magnesium hydroxide. H-2 Antagonists In studies with human volunteers, coadministration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations. Food Effects Absorption is most rapid when ibuprofen is given under fasting conditions. Administration of ibuprofen suspension with food affects the rate but not the extent of absorption. When taken with food, T max is delayed by approximately 30 to 60 minutes, and peak levels are reduced by approximately 30 to 50%. Distribution Ibuprofen, like most drugs of its class, is highly protein bound (>99% bound at 20 µg/mL). Protein binding is saturable and at concentrations >20 µg/mL binding is non-linear. Based on oral dosing data there is an age- or fever-related change in volume of distribution for ibuprofen. Febrile children <11 years old have a volume of approximately 0.2 L/kg while adults have a volume of approximately 0.12 L/kg. The clinical significance of these findings is unknown. Metabolism Following oral administration, the majority of the dose was recovered in the urine within 24 hours as the hydroxy-(25%) and carboxypropyl-(37%) phenylpropionic acid metabolites. The percentages of free and conjugated ibuprofen found in the urine were approximately 1% and 14%, respectively. The remainder of the drug was found in the stool as both metabolites and unabsorbed drug. Elimination Ibuprofen is rapidly metabolized and eliminated in the urine. The excretion of ibuprofen is virtually complete 24 hours after the last dose. It has a biphasic plasma elimination time curve with a half-life of approximately 2.0 hours. There is no difference in the observed terminal elimination rate or half-life between children and adults, however, there is an age-or fever-related change in total clearance. This suggests that the observed change in clearance is due to changes in the volume of distribution of ibuprofen (see Table 1 for CI/F values). Clinical Studies Controlled clinical trials comparing doses of 5 and 10 mg/kg ibuprofen suspension and 10-15 mg/kg of acetaminophen elixir have been conducted in children 6 months to 12 years of age with fever primarily due to viral illnesses. In these studies there were no differences between treatments in fever reduction for the first hour and maximum fever reduction occurred between 2 and 4 hours. Response after 1 hour was dependent on both the level of temperature elevation as well as the treatment. In children with baseline temperatures at or below 102.5°F both ibuprofen doses and acetaminophen were equally effective in their maximum effect. In children with temperatures above 102.5°F, the ibuprofen 10 mg/kg dose was more effective. By 6 hours, children treated with ibuprofen 5mg/kg tended to have recurrence of fever, whereas children treated with ibuprofen 10 mg/kg still had significant fever reduction at 8 hours. In control groups treated with 10 mg/kg acetaminophen, fever reduction resembled that seen in children treated with 5 mg/kg of ibuprofen, with the exception that temperature elevation tended to return 1-2 hours earlier. In patients with primary dysmenorrhea, ibuprofen has been shown to reduce elevated levels of prostaglandin activity in the menstrual fluid and to reduce testing and active intrauterine pressure, as well as the frequency of uterine contractions. The probable mechanism of action is to inhibit prostaglandin synthesis rather than simply to provide analgesia." ], "overdosage": [ "OVERDOSAGE The toxicity of ibuprofen overdose is dependent upon the amount of drug ingested and the time elapsed since ingestion, though individual response may vary, which makes it necessary to evaluate each case individually. Although uncommon, serious toxicity and death have been reported in the medical literature with ibuprofen overdosage. The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy and drowsiness. Other central nervous system symptoms include headache, tinnitus, CNS depression and seizures. Metabolic acidosis, coma, acute renal failure and apnea (primarily in very young children) may rarely occur. Cardiovascular toxicity, including hypotension, bradycardia, tachycardia and atrial fibrillation, also have been reported. The treatment of acute ibuprofen overdose is primarily supportive. Management of hypotension, acidosis and gastrointestinal bleeding may be necessary. In cases of acute overdose, the stomach should be emptied through ipecac-induced emesis or lavage. Emesis is most effective if initiated within 30 minutes of ingestion. Orally administered activated charcoal may help in reducing the absorption and reabsorption of ibuprofen. In children, the estimated amount of ibuprofen ingested per body weight may be helpful to predict the potential for development of toxicity although each case must be evaluated. Ingestion of less than 100 mg/kg is unlikely to produce toxicity. Children ingesting 100 to 200 mg/kg may be managed with induced emesis and a minimal observation time of four hours. Children ingesting 200 to 400 mg/kg of ibuprofen should have immediate gastric emptying and at least four hours observation in a health care facility. Children ingesting greater than 400 mg/kg require immediate medical referral, careful observation and appropriate supportive therapy. Ipecac-induced emesis is not recommended in overdoses greater than 400 mg/kg because of the risk for convulsions and the potential for aspiration of gastric contents. In adult patients the history of the dose reportedly ingested does not appear to be predictive of toxicity. The need for referral and follow-up must be judged by the circumstances at the time of the overdose ingestion. Symptomatic adults should be carefully evaluated, observed and supported." ], "spl_medguide_table": [ "
Serious side effects include: Other side effects include:
heart attack stroke high blood pressure heart failure from body swelling (fluid retention) kidney problems including kidney failure bleeding and ulcers in the stomach and intestine low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions liver problems including liver failure asthma attacks in people who have asthma stomach pain constipation diarrhea gas heartburn nausea vomiting dizziness
", "
Generic Name Tradename
Celecoxib Celebrex
Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbiprofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, NapraPAC (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600
" ] }, { "effective_time": "20120619", "inactive_ingredient": [ "Inactive Ingredients: Bee Propolis, Citric Acid, Corn Syrup, Echinacea Angustifolia, Echinacea Purpurea, Licorice Root, Natural Flavor, Sugar." ], "purpose": [ "Purpose Cough Suppressant Oral Anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children - beware of accidental ingestion." ], "warnings": [ "Warnings Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. A persistent cough may be a sign of a serious condition. Consult a physician promptly. Do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician. Ask a doctor before use if you have: Persistent or chronic cough associated with smoking, asthma, or emphysema Cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor if: Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache Sore mouth symptoms do not improve in 2 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children - beware of accidental ingestion." ], "questions": [ "Questions? 800-421-2998" ], "spl_product_data_elements": [ "Herbon Orange Tingle Mentol, Echinacea Purpurea, and Licorice Menthol Menthol Echinacea Purpurea Echinacea Purpurea Licorice Licorice Citric Acid Monohydrate Sucrose Corn Syrup Greenish/brown e" ], "ask_doctor": [ "Ask a doctor before use if you have: Persistent or chronic cough associated with smoking, asthma, or emphysema Cough accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults and children 3 years of age and older: allow lozenge to dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a physician. Children under 3 years of age: consult a physician." ], "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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache Sore mouth symptoms do not improve in 2 days" ], "do_not_use": [ "Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. A persistent cough may be a sign of a serious condition. Consult a physician promptly. Do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 18 Lozenge Bag herbon ® naturally flavored orange tingle herbal cough drops Soothing & Delicious Menthol - Cough Suppressant / Oral Anesthetic 18 Drops Net Wt 2.1oz (62g) Principal Display Panel - 18 Lozenge Bag" ], "indications_and_usage": [ "Uses For the temporary relief of: Cough due to minor throat and bronchial irritation associated with the common cold. Occasional minor sore throat pain, irritation and sore mouth" ], "set_id": "84d8fa30-9c31-4994-8ea1-b1eea336b20a", "id": "735ba7bd-a1b7-4c4b-89e3-5109a6233cea", "active_ingredient": [ "Active Ingredient (per drop) Menthol 5mg" ] }, { "effective_time": "20120605", "inactive_ingredient": [ "Inactive ingredients citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol" ], "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." ], "warnings": [ "Warnings Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy 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 a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks marked drowsiness may occur excitability may occur, especially in children 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." ], "when_using": [ "When using this product avoid alcoholic drinks marked drowsiness may occur excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP POLOXAMER 407 WATER SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SORBITOL Bluish-Red" ], "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 a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions if needed, take every 4-6 hours do not take more than 6 doses in 24 hours children under 4 years of age do not use children 4 to under 6 years of age do not use unless directed by a doctor children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 mg to 25 mg) adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 mg to 50 mg)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each teaspoonful contains: sodium 15 mg store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy" ], "package_label_principal_display_panel": [ "Principal Display Panel Diphenhydramine Hydrochloride 12.5 mg/ 5 mL NDC 54868-5622-0 Relieves: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat See New Warning and Dosing Directions Cherry Flavored 4 fl oz (118 mL) Alcohol Free Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146 image of package label" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itching of the nose or throat runny nose itchy, watery eyes temporarily relieves these symptoms due to the common cold: sneezing runny nose" ], "set_id": "84f14898-dbdc-408e-a521-c88fd8290f4b", "id": "fba49e33-36bd-48c5-8500-fd36b9cacb7c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each 5 mL teaspoonful) Diphenhydramine HCl 12.5 mg" ], "dosage_and_administration_table": [ "
children under 4 years of age do not use
children 4 to under 6 years of age do not use unless directed by a doctor
children 6 to under12 years of age 1 to 2 teaspoonfuls(12.5 mg to 25 mg)
adults and children 12 years of age and over 2 to 4 teaspoonfuls(25 mg to 50 mg)
" ] }, { "effective_time": "20150722", "inactive_ingredient": [ "Inactive ingredietns acesulfame potassium, alcohol, citric acid hydrate, FD&C Green No. 3, FD&C No. 5, glycerin, high fructose corn syrup, L-menthol, methylparaben, mint essence, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate hydrate, sodium chloride, sodium saccharin" ], "purpose": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever running nose and sneezing" ], "keep_out_of_reach_of_children": [ "Keep our of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "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" ], "spl_product_data_elements": [ "Family Care Cold and Flu Nighttime Acetaminophen, Dextromethorphan hydrobromide, and Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACESULFAME POTASSIUM ALCOHOL HYDROXYCITRIC ACID FD&C GREEN NO. 3 FD&C YELLOW NO. 5 GLYCERIN HIGH FRUCTOSE CORN SYRUP MENTHOL METHYLPARABEN POLYETHYLENE GLYCOLS PROPYLPARABEN WATER SODIUM CHLORIDE SACCHARIN SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Distributed by: United Exchange Corp. Cerritos, CA 90703 U.S.A. Made in Korea" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occurs cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each 30 mL dose cup contains: potassium 4 mg sodium 33 mg store at room temperature" ], "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 MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "Directions take only as directed use dose cup or tablespoon (TBSP) 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" ], "set_id": "85e15203-6d84-4361-877a-7342f070b938", "id": "d9ec2557-0197-4f78-bca2-7d299bc04a16", "active_ingredient": [ "Active ingredients (in each 30 mL dose cup) Purpose Acetaminophen 650 mg....................................................Pain reliever/fever reducer Dextromethorphan HBr 30 mg.....................................................Cough suppressant Doxylamine succinate 12.5 mg............................................................Antihistamine" ] }, { "effective_time": "20120618", "inactive_ingredient": [ "Inactive Ingredients: Beta-Carotene with mixed Carotenoids, Citric Acid, Corn Syrup, Echinacea Angustifolia, Echinacea Purpurea, Lemon Balm, Linden Flower, Natural Lemon and Honey Flavoring, Sugar, Thyme." ], "purpose": [ "Purpose Soothes Sore Throats" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children - beware of accidental ingestion." ], "warnings": [ "Warnings Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. Consult a physician promptly. Do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician. Ask a doctor before use if you have: Persistent or chronic cough associated with smoking, asthma, or emphysema Cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor if: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, persistent headache, rash, nausea, or vomiting. Sore mouth symptoms do not improve in 2 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children - beware of accidental ingestion." ], "questions": [ "Questions? 800-421-2998" ], "spl_product_data_elements": [ "Herbon Lemon Honey Herbal Menthol Menthol Menthol Citric Acid Monohydrate Corn Syrup Sucrose ECHINACEA ANGUSTIFOLIA ROOT Echinacea Purpurea" ], "ask_doctor": [ "Ask a doctor before use if you have: Persistent or chronic cough associated with smoking, asthma, or emphysema Cough accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children 3 years of age and older: allow lozenge to dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a physician. Children under 3 years of age: consult a physician." ], "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: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, persistent headache, rash, nausea, or vomiting. Sore mouth symptoms do not improve in 2 days" ], "do_not_use": [ "Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. Consult a physician promptly. Do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 18 Lozenge Bag herbon ® naturally flavored lemon honey herbal throat drops Soothing & Delicious Menthol - Soothes Sore Throats 18 Drops Net Wt 2.1oz (62g) Principal Display Panel - 18 Lozenge Bag" ], "indications_and_usage": [ "Uses For the temporary relief of: Occasional minor sore throat pain, irritation and sore mouth" ], "set_id": "87b442b6-de88-4f53-a54a-542f7d97cea1", "id": "15fda7d2-4b50-4493-bbcf-945f92f78f3c", "active_ingredient": [ "Active Ingredient (per drop) Menthol 3mg" ] }, { "effective_time": "20150731", "inactive_ingredient": [ "Inactive Ingredients Alcohol, Citric Acid, Corn Syrup, Purified Water, Pyridoxine HCL, Sodium Benzoate, Sodium Chloride" ], "purpose": [ "Purpose: Skin protectant/Astringent" ], "keep_out_of_reach_of_children": [ "​KEEP OUT OF REACH OF CHILDREN" ], "precautions": [ "​Avoid contact with eyes ​" ], "warnings": [ "Warnings: For External Use Only ​Discontinue use if symptoms persist for more than 7 days and consult a physician Do not use on children under 6 years of age without consulting a physician" ], "spl_product_data_elements": [ "Dermadrox Zinc Acetate ZINC ACETATE ZINC CATION ALCOHOL CITRIC ACID MONOHYDRATE CORN SYRUP WATER PYRIDOXINE HYDROCHLORIDE SODIUM BENZOATE SODIUM CHLORIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply generously as often as necessary to minor burns, abraded skin, irritated areas and minor wounds. Spray directly on the affected area with a thin coat of Dermadrox Reapply at least every 12 hours. May be used as a wet dressing" ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "Intended Use: Rehydrates damaged tissues and protects chaffed, chapped, cracked, or burned skin." ], "set_id": "87dc161d-aaef-4ff3-8d26-a301ea9cd6c5", "id": "f4238cc8-536d-4900-ae6e-ddb3b3cc9fbb", "active_ingredient": [ "Active Zinc Acetate 0.45%" ] }, { "effective_time": "20130617", "inactive_ingredient": [ "Inactive ingredients citric acid, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, xanthan gum" ], "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 chronic cough that lasts 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, 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. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-888-963-3382 You may also report side effects to this phone number." ], "spl_product_data_elements": [ "Delsym Dextromethorphan Dextromethorphan Dextromethorphan Dextromethorphan Hydrobromide Polistirex citric acid monohydrate edetate disodium ethylcelluloses FD&C Yellow No. 6 high fructose corn syrup methylparaben polyethylene glycol 3350 polysorbate 80 propylene glycol propylparaben water sucrose tragacanth xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if you have chronic cough that lasts as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions shake bottle well before use 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 of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age 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: Reckitt Benckiser, Parsippany, NJ 07054-0224 ©RB 2011" ], "stop_use": [ "Stop use and ask a doctor if cough 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." ], "storage_and_handling": [ "Other information each 5 mL contains: sodium 7 mg store at 20°-25°C (68°-77°F) dosing 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": [ "PRINCIPAL DISPLAY PANEL NDC 54569-1051-0 Relabeled by: A-S Medication Solutions Libertyville, IL 60048 1051-0.jpg" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep" ], "set_id": "8df339ba-3075-4661-8344-6ac5e1eb3206", "id": "d3af1d05-a1ed-4351-8d07-db204e07e6f7", "active_ingredient": [ "Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
children under 4 years of age do not use
" ] }, { "effective_time": "20090909", "inactive_ingredient": [ "Non-medicinal Ingredients: Natural flavours (lemon, wintermint), natural colours (alfalfa, carmine, curcumin), corn syrup, sugar." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "Risk Information: Consult a health care practitioner if symptoms persist or worsen, if sore throat symptoms are severe or persist for more than two days, if cough worsens, persists for more than seven days or is accompanied by high fever. Consult a health care practitioner prior to use if you take immunosuppressants or have a progressive systemic disease such as tuberculosis, leukosis, collagenosis or multiple sclerosis." ], "spl_product_data_elements": [ "Herbon Glacial Mint Echinacea Purpurea, Menthol, and Eucalyptus Oil Echinacea Purpurea Echinacea Menthol Menthol Eucalyptus Oil Eucalyptus Oil Sucrose Corn Syrup Slightly opaque light yellowish green with deep pink and bright yellow speckles lemon, wintermint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Recommended Dose: Adolescents (10 to 14 years): Dissolve 1 lozenge slowly in the mouth three times daily or more as needed. Adults and adolescents (14 years and older): Dissolve 1 lozenge slowly in the mouth six times daily or more as needed. Note: Do not exceed 14 lozenges per day. Consult a health care practitioner for use beyond eight weeks." ], "storage_and_handling": [ "STORE IN A COOL, DRY PLACE." ], "do_not_use": [ "DO NOT USE IF BAG IS OPEN OR TORN." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 20 Lozenge Bag Herbon ® ECHINACEA Cough and Sore Throat Drops Original Temporary Relief of Cough & Sore Throat Helps Ease Nasal Congestion ALL NATURALLY-SOURCED ACTIVE INGREDIENTS Extra Strength GLACIAL MINT REFRESHING BURTS of LEMON and WINTERMINT 20 Lozenges Principal Display Panel" ], "indications_and_usage": [ "INDICATIONS AND USAGE Recommended Use: For the temporary relief of cough and sore throat pain. Helps relieve nasal congestion and make nasal passages feel clearer. Helps shorten the duration and relieve symptoms of the common cold." ], "set_id": "91ac7990-bac1-4ed6-bfa0-ae6cba88dc4e", "id": "a3fd4c19-574d-4aee-bae9-4c9972da6fe9", "active_ingredient": [ "Medicinal Ingredients: Each lozenge contains: Echinacea (Echinacea purpurea) root extract 22:1 (equivalent to 162 mg dried herb) ................................7.35 mg Menthol (from Mentha arvensis leaf) ...................................10 mg Eucalyptus oil ( Eucalyptus globulus ) .....................................6 mg" ] }, { "effective_time": "20150910", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Demineralized water, 10% Ethanol, Anise oil, Eucalyptus oil, Chamomile (flower), Echinacea angustifolia (tops), High mallow (flower), Iceland moss (whole plant), Mullein (leaf), Plantain (leaf), Red clover (flower), Stinging nettle (leaf), Thyme (leaf), High fructose corn syrup, Natural cherry and Mixed berry flavorings." ], "purpose": [ "INDICATIONS: For temporary relief of irritable, dry, tickling cough associated with flu, spasmodic cough worse at night and cough with expectorations." ], "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: 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. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place." ], "questions": [ "Distributed by: BIOACTIVE NUTRITIONAL Melbourne, FL 32935 For Nutritional Information write: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935" ], "spl_product_data_elements": [ "Cough Drosera rotundifolia, Coccus cacti, Spongia tosta, Belladonna, Cuprum aceticum, Kali carbonicum, Mentha piperita, Phosphorus DROSERA ROTUNDIFOLIA DROSERA ROTUNDIFOLIA PROTORTONIA CACTI PROTORTONIA CACTI SPONGIA OFFICINALIS SKELETON, ROASTED SPONGIA OFFICINALIS SKELETON, ROASTED ATROPA BELLADONNA ATROPA BELLADONNA CUPRIC ACETATE CUPRIC CATION POTASSIUM CARBONATE CARBONATE ION MENTHA PIPERITA MENTHA PIPERITA PHOSPHORUS PHOSPHORUS WATER ALCOHOL CHAMOMILE ECHINACEA ANGUSTIFOLIA MALVA SYLVESTRIS FLOWER CETRARIA ISLANDICA SUBSP. ISLANDICA VERBASCUM DENSIFLORUM LEAF PLANTAGO MAJOR RED CLOVER URTICA DIOICA LEAF THYME HIGH FRUCTOSE CORN SYRUP CHERRY BERRY ANISE OIL EUCALYPTUS OIL" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DIRECTIONS: SHAKE WELL 1 teaspoon every 2-3 hours, children under 12, 1/2 adult dose. Consult a physician for use in children under 12 years of age." ], "package_label_principal_display_panel": [ "BioActive Homeopathic COUGH SYRUP FORMULA 4 FL OZ (120 ml) Cough Syrup" ], "indications_and_usage": [ "INDICATIONS: For temporary relief of irritable, dry tickling cough associated with flu, spasmodic cough worse at night and cough with expectorations." ], "set_id": "92289c14-9ea7-4a23-95f2-fedbc37cc96f", "id": "91f121a7-b613-4792-ac43-765f9f2d4f4c", "active_ingredient": [ "ACTIVE INGREDIENTS: Drosera rotundifolia 3X, Coccus cacti 5X, Spongia tosta 5X, Belladonna 6X, Cuprum aceticum 12X, Kali carbonicum 12X, Mentha piperita 12X, Phosphorus 12X." ] }, { "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": "20110404", "inactive_ingredient": [ "Inactive ingredients corn syrup, honey, glycine, lemon oil, natural green tea flavor and sucrose. No artificial colors or preservatives." ], "purpose": [ "Purpose Homeopathic Cold Remedy" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor before use if you are taking monocycline, doxycycline, tetracycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medicines Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days. COLD-EEZE® Lozenges are formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children." ], "questions": [ "QUESTIONS? COMMENTS? CALL 1-800-505-COLD 9am - 5pm Eastern" ], "spl_product_data_elements": [ "Cold-EEZE Zinc Gluconate Zinc Gluconate Zinc Corn Syrup Glycine Sucrose Semi-Translucent P Green Tea" ], "ask_doctor": [ "Ask a doctor before use if you are taking monocycline, doxycycline, tetracycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medicines" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and over for best results, begin treatment at start of symptoms (within 24-48 hours of onset) repeat every 2 - 4 hours as needed until all symptoms subside completely dissolve a COLD-EEZE® lozenge in mouth (do not chew) recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17 children under 12 years of age should consult a health professional prior to use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information avoid minor stomach upset - Do not dissolve COLD-EEZE® lozenges on an empty stomach avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking COLD-EEZE® lozenges as they may diminish product effectiveness, otherwise, drink plenty of fluids", "gluten-free" ], "stop_use": [ "Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days." ], "storage_and_handling": [ "store in a cool dry place after opening" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 18 Lozenge Carton Shorten your cold! Get better faster! Quigley Homeopathic Cold-EEZE ® Clinically proven to reduce the duration of the common cold Zinc Gluconate Glycine PHARMACIST RECOMMENDED • #1 ACHIEVEMENT AWARD 18 Cold Remedy Lozenges Natural Green Tea with Honey Flavor with other natural flavors Principal Display Panel - 18 Lozenge Carton" ], "indications_and_usage": [ "Uses to reduce the duration of the common cold reduces the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness" ], "set_id": "969b0895-0d14-47e7-adf8-33730c69e686", "id": "9df15ad0-033c-413e-9e3a-0124c8c2b620", "active_ingredient": [ "Active ingredient (per lozenge) Zincum Gluconicum 2x (13.3mg)" ] } ] }