{ "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": 4 } }, "results": [ { "spl_product_data_elements": [ "Nighttime Cold and Flu Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr FD&C BLUE NO. 1 D&C YELLOW NO. 10 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL SOLUTION SORBITAN ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE CF02" ], "active_ingredient": [ "Active ingredients (in each Softgels) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "purpose": [ "Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine" ], "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" ], "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 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 more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease glaucoma 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 excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drink 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_unclassified_section": [ "If pregnant or breast-feeding, ask a health professional before use.", "Distributed by: Health Pharma USA LLC Rahway, NJ 07065 www.health-Pharma.us" ], "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 as well as for children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Direction take only as directed do not exceed 4 doses per 24 hours adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over2 softgels with water every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
" ], "other_safety_information": [ "Other information store at room temperature." ], "inactive_ingredient": [ "Inactive ingredients D&C yellow# 10, FD&C Blue #1, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution" ], "questions": [ "Questions or comments? 1-844-832-1138 M-F 9am-5pm EST" ], "package_label_principal_display_panel": [ "PACKAGE LABEL image" ], "set_id": "29bb7822-76c6-e39d-e063-6294a90a64fb", "id": "2b2207d5-7fd6-5737-e063-6394a90acc00", "effective_time": "20250107", "version": "5", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Nighttime Cold and Flu" ], "generic_name": [ "ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR" ], "manufacturer_name": [ "Health Pharma USA LLC" ], "product_ndc": [ "71679-102" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "DOXYLAMINE SUCCINATE" ], "rxcui": [ "1094549" ], "spl_id": [ "2b2207d5-7fd6-5737-e063-6394a90acc00" ], "spl_set_id": [ "29bb7822-76c6-e39d-e063-6294a90a64fb" ], "package_ndc": [ "71679-102-50", "71679-102-00" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2" ] } } ] }