{"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 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_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 take 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 When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing."],"dosage_and_administration_table":["
adults and children 12 years of age and over take 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":"20241125","id":"27c79edd-88b5-a290-e063-6394a90a894c","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 directed can cause serious health problems. 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 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":["53345-026-01"],"product_ndc":["53345-026"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["27c79edd-88b5-a290-e063-6394a90a894c"],"spl_set_id":["7a28d0fe-0e0a-453a-b604-1cc784dd153c"],"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 : 53345-026-01 IMPORTANT: 1.Inspect immediately upon receipt. 2.This is a bulk shipment, intended for further processing only. 3.Protect from heat, humidity, and light. Do not refrigerate. 4.Store at 15-30°C (59-86°F) CAUTION : \"FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING\" Shipping 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":"7a28d0fe-0e0a-453a-b604-1cc784dd153c","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, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE oblong 660"],"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."],"storage_and_handling":["Other information store at room temperature 15°-30°C (59°-86°F)"],"version":"3","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 Sore throat warning If sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly."],"when_using":["When using this product 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"]}