{ "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": "2026-10-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Nighttime Cold/Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL SORBITAN TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE 603" ], "active_ingredient": [ "Drug Facts Active ingredients (in each Softgel) Acetaminophen ................325 mg Dextromethorphan HBr ......15 mg Doxylamine succinate .........6.25 mg" ], "purpose": [ "Purpose Acetaminophen ........................Pain reliever/Fever reducer Dextromethorphan HBr .............Cough suppressant Doxylamine succinate ............... Antihistamine" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: ■ cough due to minor throat & bronchial irritation ■ sore throat ■ headache ■ minor aches and pain ■ fever ■ runny nose and sneezing" ], "warnings": [ "Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4doses in 24 hrs, 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 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, occurs with or is followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly." ], "do_not_use": [ "Do not use: ■ with any other products 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_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 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 produc t, 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": [ "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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "overdosage": [ "In case of accidental overdose , get medical help or contact a Poison Control center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions ■ take only as directed (see Warning) ■ do not exceed 4 doses per 24 hours adults & children 12 yrs & over 2 soft gels with water every 6 hours children 4 to under 12 years: ask a doctor children under 4 years: do not use ■ When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing." ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over 2 soft gels with water every 6 hours
children 4 to under 12 years:ask a doctor
children under 4 years: do not use
" ], "other_safety_information": [ "Other information ■ Store at room temperature 20-25º C (68-77º F) ■ avoid excessive heat" ], "inactive_ingredient": [ "Inactive ingredients D&C Yellow # 10, FD&C Blue # 1, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide." ], "questions": [ "Questions? Call Weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944" ], "package_label_principal_display_panel": [ "Product Label: exchange select NightTime Cold/Flu Relief exchange select Nighttime Cold/Flu Relief 24 Softgels Manufactured For Your Military Exchange By AptaPharma Inc., 1533 Union Avenue, Pennsauken, NJ 08110 1-877-798-5944 aptapharma.com res 603-03 crtn" ], "set_id": "029e6215-b72d-4fd0-8918-db1abcc4490a", "id": "4652ed1a-8024-2fa2-e063-6394a90a8d0f", "effective_time": "20251219", "version": "4", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Nighttime Cold/Flu Relief" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE" ], "manufacturer_name": [ "ARMY AND AIR FORCE EXCHANGE SERVICE" ], "product_ndc": [ "55301-603" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "DOXYLAMINE SUCCINATE" ], "rxcui": [ "1094549" ], "spl_id": [ "4652ed1a-8024-2fa2-e063-6394a90a8d0f" ], "spl_set_id": [ "029e6215-b72d-4fd0-8918-db1abcc4490a" ], "package_ndc": [ "55301-603-03" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2" ] } } ] }