{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg"],"dosage_and_administration":["Directions • take only as directed • do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["
adults & children 12 yrs & over 2 softgels with water every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
"],"effective_time":"20250117","id":"fb4c197e-d90f-43f0-a8db-b997b4748371","inactive_ingredient":["Inactive ingredients D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide"],"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: 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 for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Kroger NightTime Cold and Flu SOFTGEL"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["The Kroger Co."],"package_ndc":["59450-047-48"],"product_ndc":["59450-047"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["fb4c197e-d90f-43f0-a8db-b997b4748371"],"spl_set_id":["24a73de3-e9eb-4cd4-e063-6394a90aa263"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"]},"package_label_principal_display_panel":["Packaging Kroger-047"],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Antihistamine"],"questions":["Questions or comments? 1-800-632-6900"],"set_id":"24a73de3-e9eb-4cd4-e063-6394a90aa263","spl_product_data_elements":["Kroger NightTime Cold and Flu SOFTGEL Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SORBITOL SORBITAN TITANIUM DIOXIDE 902"],"spl_unclassified_section":["Drug Facts","COMPARE TO the active ingredients of VICKS ® NYQUIL ® COLD & FLU NIGHTTIME RELIEF LIQUICAPS™* POWERFUL NIGHTTIME RELIEF Multi-Symptom Relief TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 QUALITY GUARANTEE www.kroger.com PRODUCT OF INDIA *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the trademarks Vicks ® , NyQuil™ and LiquiCaps™. REV.00-092024 PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND INFORMATION"],"storage_and_handling":["Other information • store at room temperature between 20°-25°C (68°-77°F) • protect from light, heat, and moisture"],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 softgels in 24 hrs, 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 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. Ask a doctor before use if you have • liver disease • heart disease • thyroid disease • diabetes • 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 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 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: 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 for children even if you do not notice any signs or symptoms."]}