{ "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": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "NIGHTTIME COLD AND FLU Acetaminophen, Doxylamine succinate and Dextromethorphan HBr PROPYLENE GLYCOL SODIUM BENZOATE XANTHAN GUM GLYCERIN D&C YELLOW NO. 10 WATER FD&C GREEN NO. 3 SUCRALOSE MENTHOL ANHYDROUS CITRIC ACID SORBITOL SOLUTION 70% FD&C YELLOW NO. 6 ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE" ], "active_ingredient": [ "Drug Facts Active ingredients (in each 30 mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg" ], "purpose": [ "Purpose Pain Reliever/Fever Reducer Cough Suppressant Antihistamine" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: • sore throat • minor aches and pains • runny nose and sneezing • headache • fever • cough due to minor throat and bronchial irritation." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: • adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day while using this product. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, lasts for mroe than 2 days, is accompanied or followed by fever, heacache, rash, nausea, or vomiting, consult a doctor promptly." ], "do_not_use": [ "Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • if you have ever had an allergic reaction to this product or anay of its ingredients" ], "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 occur with smoking, asthma, chronic bronchitis or emphysema • trouble urinating due to an enlarged prostate gland." ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin." ], "when_using": [ "When using this product • do not use more than directed (see overdose warning) • avoid alcoholic drinks • excitability may occur, especially in children • marked drowsiness may occur • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness." ], "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." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children." ], "overdosage": [ "Overdose warning: Taking mroe 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 for adults as well as for children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions • take only as directed (see overdose warning) • measure only with dosing cup provided and keep dosage cup with product • mL=mililiter • do not exceed 4 doses per 24 hours Age Dose adults and children 12 years and over 30 mL every 6 hours children under 12 years do not use" ], "dosage_and_administration_table": [ "
AgeDose
adults and children 12 years and over30 mL every 6 hours
children under 12 yearsdo not use
" ], "other_safety_information": [ "Other Information • Each 30 mL dose cup contains: sodium 10 mg • store at room temperature 15-30°C (59-86°F) and do not refrigerate" ], "inactive_ingredient": [ "Inactive ingredients citric acid, D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum." ], "questions": [ "Questions or comments? 1-844-912-4012" ], "package_label_principal_display_panel": [ "label" ], "set_id": "36aa5df7-8722-4b80-aa04-d869bc944311", "id": "3590d417-272f-ae4d-e063-6394a90a5dc6", "effective_time": "20250501", "version": "1", "openfda": { "application_number": [ "M012" ], "brand_name": [ "NIGHTTIME COLD AND FLU" ], "generic_name": [ "ACETAMINOPHEN, DOXYLAMINE SUCCINATE AND DEXTROMETHORPHAN HBR" ], "manufacturer_name": [ "BI-MART" ], "product_ndc": [ "37835-525" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "DOXYLAMINE SUCCINATE" ], "rxcui": [ "1043400" ], "spl_id": [ "3590d417-272f-ae4d-e063-6394a90a5dc6" ], "spl_set_id": [ "36aa5df7-8722-4b80-aa04-d869bc944311" ], "package_ndc": [ "37835-525-12" ], "is_original_packager": [ true ], "upc": [ "0071357912452" ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2" ] } } ] }