{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Dimetapp Cold and Cough and Nighttime Cold and Cough DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, and DEXTROMETHORPHAN HYDROBROMIDE Dimetapp Nighttime Cold and Cough DIPHENHYDRAMINE HYDROCHLORIDE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Dimetapp Cold and Cough brompheniramine maleate, dextromethorphan hydrobromide ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE BROMPHENIRAMINE MALEATE BROMPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN" ], "spl_unclassified_section": [ "Dimetapp ® Nighttime Cold and Cough Drug Facts", "Dimetapp ® Cold and Cough Drug Facts", "Distributed by: Foundation Consumer Healthcare, LLC, Pittsburgh, PA 15212" ], "active_ingredient": [ "Active ingredient (in each 10 mL) Purpose Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant", "Active ingredients (in each 10 mL) Purposes Brompheniramine maleate, 2 mg Antihistamine Dextromethorphan HBr, 10 mg Cough suppressant" ], "active_ingredient_table": [ "
Active ingredient (in each 10 mL)Purpose
Diphenhydramine HCl, 12.5 mgAntihistamine/cough suppressant
", "
Active ingredients (in each 10 mL)Purposes
Brompheniramine maleate, 2 mgAntihistamine
Dextromethorphan HBr, 10 mgCough suppressant
" ], "purpose": [ "Active ingredient (in each 10 mL) Purpose Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant", "Active ingredients (in each 10 mL) Purposes Brompheniramine maleate, 2 mg Antihistamine Dextromethorphan HBr, 10 mg Cough suppressant" ], "purpose_table": [ "
Active ingredient (in each 10 mL)Purpose
Diphenhydramine HCl, 12.5 mgAntihistamine/cough suppressant
", "
Active ingredients (in each 10 mL)Purposes
Brompheniramine maleate, 2 mgAntihistamine
Dextromethorphan HBr, 10 mgCough suppressant
" ], "indications_and_usage": [ "Uses temporarily relieves: cough runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever (or other respiratory allergies) relieves the impluse to cough to help you sleep", "Uses temporarily relieves: cough runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever (or other respiratory allergies) temporarily alleviates the intensity of coughing" ], "warnings": [ "Warnings Do not use to sedate a child or to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if 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.", "Warnings Do not use to sedate a child or to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if 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." ], "do_not_use": [ "Do not use to sedate a child or to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Do not use to sedate a child or to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "ask_doctor": [ "Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema", "Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "when_using": [ "When using this product do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "When using this product do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "stop_use": [ "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.", "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." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions do not take more than 6 doses in any 24-hour period measure only with dosage cup provided keep dosage cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use", "Directions do not take more than 6 doses in any 24-hour period measure only with dosage cup provided keep dosage cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use" ], "dosage_and_administration_table": [ "
agedose
adults and children 12 years and over20 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
children under 6 yearsdo not use
", "
agedose
adults and children 12 years and over20 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
children under 6 yearsdo not use
" ], "storage_and_handling": [ "Other information each 10 mL contains: sodium 8 mg store at 20-25°C (68-77°F) do not refrigerate", "Other information each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F)" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose", "Inactive ingredients anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "questions": [ "Questions or comments? Call 1-888-594-0828 weekdays 9 AM to 5 PM EST", "Questions or comments? Call 1-888-594-0828 weekdays 9 AM to 5 PM EST" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Kit Carton COLD & COUGH NEW FORMULAS CHILDREN'S Dimetapp ® Cold & Cough BROMPHENIRAMINE MALEATE (Antihistamine) DEXTROMETHORPHAN HBr (Cough Suppressant) Relieves + comforts: Runny nose Itchy, watery eyes Sneezing Cough 6+ YRS Grape Flavor Alcohol Free 1 BOTTLE 4 FL OZ (118 mL) 8 FL OZ (236 mL) TOTAL NIGHTTIME Nighttime Cold & Cough DIPHENHYDRAMINE HCl (Antihistamine/ Cough Suppressant) Relieves + comforts: Runny nose Itchy, watery eyes Sneezing Cough PHARMACIST RECOMMENDED 6+ YRS Grape Flavor Alcohol Free 1 BOTTLE 4 FL OZ (118 mL) Dimetapp 8oz Carton" ], "set_id": "179259a9-231e-df03-e063-6294a90a145e", "id": "17925cc1-55d4-5673-e063-6394a90aabcb", "effective_time": "20240601", "version": "1", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Dimetapp Cold and Cough and Nighttime Cold and Cough" ], "generic_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE" ], "manufacturer_name": [ "Foundation Consumer Healthcare" ], "product_ndc": [ "69536-355" ], "product_type": [ "HUMAN OTC DRUG" ], "rxcui": [ "1049884", "2683421", "2683422" ], "spl_id": [ "17925cc1-55d4-5673-e063-6394a90aabcb" ], "spl_set_id": [ "179259a9-231e-df03-e063-6294a90a145e" ], "package_ndc": [ "69536-355-08", "69536-345-04", "69536-315-04" ], "is_original_packager": [ true ] } } ] }