{"active_ingredient":["Active ingredients (in each softgels) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg"],"dosage_and_administration":["Direction take only as directed do not exceed 4 doses per 24 hours adults and children 12 years and over take 2 softgels with water every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use"],"dosage_and_administration_table":["<table width=\"100%\"><caption/><tbody><tr><td><content styleCode=\"bold\">adults and children 12 years and over</content></td><td>take 2 softgels with water every 6 hours</td></tr><tr><td><content styleCode=\"bold\">children 4 to under 12 years</content></td><td>ask a doctor</td></tr><tr><td><content styleCode=\"bold\">children under 4 years</content></td><td>do not use</td></tr></tbody></table>"],"effective_time":"20250301","id":"2f6abd4c-7484-3bc0-e063-6294a90a7d4a","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"],"indications_and_usage":["Uses Temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing"],"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 (1-800-222-122) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Nighttime Cold and Flu Relief"],"generic_name":["ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["Bi-Mart"],"package_ndc":["37835-522-24","37835-522-96"],"product_ndc":["37835-522"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["2f6abd4c-7484-3bc0-e063-6294a90a7d4a"],"spl_set_id":["e2271f60-aad0-4e85-b5b2-9340e815f88b"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"],"upc":["0071357916344","0071357911073"]},"other_safety_information":["Other information store at room temperature. DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL-24 Count NDC 37835-522-24 Compare to the active ingredients in Vicks ® NyQuil ® Cold & Flu LiquiCaps ® * NIGHTTIME COLD AND FLU RELIEF Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr 24 SoftGels *This product is not manufactured or distributed by the owner of the registered trademark Vicks ® NyQuil ® Cold & Flu LiquiCaps ® * label","PRINCIPAL DISPLAY PANEL-96 Count NDC 37835-522-96 Compare to the active ingredients in Vicks ® NyQuil ® Cold & Flu LiquiCaps ® * NIGHTTIME COLD AND FLU RELIEF Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr 96 SoftGels *This product is not manufactured or distributed by the owner of the registered trademark Vicks ® NyQuil ® Cold & Flu LiquiCaps ® * label-96"],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Antihistamine"],"questions":["Questions? call toll-free 1-844-912-4012"],"set_id":"e2271f60-aad0-4e85-b5b2-9340e815f88b","spl_product_data_elements":["Nighttime Cold and Flu Relief 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"],"spl_unclassified_section":["If pregnant or breast-feeding, ask a health professional before use.","Distributed by: BI-MART Eugene, OR 97402"],"version":"1","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 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, persists 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 non-prescription). 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 any of its ingredients 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 do not exceed recommended dosage 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."]}