{"active_ingredient":["Drug Facts Active ingredients (in each 30 mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg"],"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."],"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"],"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
"],"effective_time":"20250501","id":"3590d417-272f-ae4d-e063-6394a90a5dc6","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."],"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."],"keep_out_of_reach_of_children":["Keep out of the reach of children."],"openfda":{"application_number":["M012"],"brand_name":["NIGHTTIME COLD AND FLU"],"generic_name":["ACETAMINOPHEN, DOXYLAMINE SUCCINATE AND DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["BI-MART"],"package_ndc":["37835-525-12"],"product_ndc":["37835-525"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1043400"],"spl_id":["3590d417-272f-ae4d-e063-6394a90a5dc6"],"spl_set_id":["36aa5df7-8722-4b80-aa04-d869bc944311"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"],"upc":["0071357912452"]},"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"],"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."],"package_label_principal_display_panel":["label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain Reliever/Fever Reducer Cough Suppressant Antihistamine"],"questions":["Questions or comments? 1-844-912-4012"],"set_id":"36aa5df7-8722-4b80-aa04-d869bc944311","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"],"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."],"version":"1","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."],"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."]}