{"active_ingredient":["Active ingredients (in each capsule) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma cough with excessive phlegm(mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema difficulty in 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. To make a child sleep"],"dosage_and_administration":["Directions take only as directed - see overdose warning do not exceed 4 doses per 24 hours Adults and children 12 years of age and over Swallow 2 softgels with water every 6 hours Children 4 to 12 years of age ask a doctor children under4 years o9f age do not use If taking NIGHTTIME and DAYTIME softgels carefully read each label to insure correct dosing."],"dosage_and_administration_table":["
Adults and children 12 years of age and over Swallow 2 softgels with water every 6 hours
Children 4 to 12 years of age ask a doctor
children under4 years o9f agedo not use
"],"effective_time":"20241121","id":"276790ce-21a1-7191-e063-6294a90adb7e","inactive_ingredient":["Inactive ingredients D&C Yellow # 10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China"],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches/pains fever runny nose & sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms ."],"openfda":{"application_number":["M012"],"brand_name":["Nighttime Cold and Flu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."],"package_ndc":["53345-006-01"],"product_ndc":["53345-006"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["276790ce-21a1-7191-e063-6294a90adb7e"],"spl_set_id":["a01abac3-c13e-40f2-ae98-34bd6c9b7504"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Shipping Label NIGHTTIME COLD AND FLU CAPSULES Quantity : 4000 Capsules NDC. No : 53345-006-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : \"FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING\" NightTime Capsules Bulk Label PLD 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"],"set_id":"a01abac3-c13e-40f2-ae98-34bd6c9b7504","spl_product_data_elements":["Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL POVIDONE PROPYLENE GLYCOL WATER SORBITOL ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE oblong PC10"],"stop_use":["Stop use and Ask a doctor if you get nervous, dizzy, or sleepless swelling or redness is present symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new symptoms occur cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache. These may be signs of a serious condition."],"storage_and_handling":["Other information store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat this product does not contain phenylpropanolamine (PPA)"],"version":"4","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 with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly."],"when_using":["When using this product do not exceed the recommended dosage do not use for more than 7 days excitability may occur especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"]}