{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 25 } }, "results": [ { "spl_product_data_elements": [ "childrens cold cough brompheniramine maleate, dextromethorphan hydrobromide BROMPHENIRAMINE MALEATE BROMPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL SOLUTION" ], "active_ingredient": [ "Active ingredients (in each 10 mL) Brompheniramine maleate 2 mg Dextromethorphan HBr 10 mg" ], "purpose": [ "Purposes Antihistamine Cough suppressant" ], "indications_and_usage": [ "Uses • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold • temporarily relieves these symptoms due to hay fever (allergic rhinitis): • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat" ], "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 sleepy 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 such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • do not use more than directed • may cause marked drowsiness • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children Stop use and ask a doctor if 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children." ], "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 sleepy" ], "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 such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "when_using": [ "When using this product • do not use more than directed • may cause marked drowsiness • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children" ], "stop_use": [ "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." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "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 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 over20 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
children under 6 yearsdo not use
" ], "other_safety_information": [ "Other information • each 10 mL contains: sodium 4 mg • store at 20°-25°C (68°-77°F)" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel meijer ® CHILDREN’S | ages 6 & up cold & cough Brompheniramine Maleate (Antihistamine) Dextromethorphan HBr (Cough Suppressant) COMPARE TO CHILDREN’S DIMETAPP ® COLD & COUGH ACTIVE INGREDIENTS RELIEVES: RUNNY NOSE, ITCHY, WATERY EYES COUGHING, SNEEZING GRAPE FLAVOR Multi-Symptom Alcohol Free Safe and Effective Relief without Phenylephrine 4 FL OZ (118 mL) cold & cough" ], "set_id": "026e530f-e133-4f20-bac5-354fbb647c9e", "id": "af35a90c-4420-4d73-80ee-fa6db5af564c", "effective_time": "20250708", "version": "2", "openfda": { "application_number": [ "M012" ], "brand_name": [ "childrens cold cough" ], "generic_name": [ "BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE" ], "manufacturer_name": [ "Meijer, Inc." ], "product_ndc": [ "79481-1200" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BROMPHENIRAMINE MALEATE", "DEXTROMETHORPHAN HYDROBROMIDE" ], "rxcui": [ "2683421" ], "spl_id": [ "af35a90c-4420-4d73-80ee-fa6db5af564c" ], "spl_set_id": [ "026e530f-e133-4f20-bac5-354fbb647c9e" ], "package_ndc": [ "79481-1200-0" ], "is_original_packager": [ true ], "unii": [ "IXA7C9ZN03", "9D2RTI9KYH" ] } } ] }