{"active_ingredient":["Active Ingredients (in each capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Doxylamine Succinate USP 6.25 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • cough that occurs with excessive phlegm (mucus) • difficulty in urination due to enlargement of the prostate gland • persistent or chronic cough such as occurs with smoking, asthma, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are 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 any of its ingredients • in children under 12 years of age"],"dosage_and_administration":["Directions • do not take more than the recommended dose • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. • children under 12 years: do not use"],"effective_time":"20260127","id":"490b40e4-c895-2eee-e063-6394a90a1a0a","inactive_ingredient":["Inactive ingredients D&C yellow no.10, FD&C blue no.1, gelatin, glycerin, mica, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves these symptoms due to a cold or flu : • minor aches and pains • headache • cough • sore throat • nasal and sinus congestion • temporarily reduces fever"],"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 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":["Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["SOFTGEL HEALTHCARE PRIVATE LIMITED"],"package_ndc":["35916-0189-1"],"product_ndc":["35916-0189"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1426334"],"spl_id":["490b40e4-c895-2eee-e063-6394a90a1a0a"],"spl_set_id":["2f7f078e-de04-9d53-e063-6394a90a409f"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"]},"other_safety_information":["Other Information • store at room temperature. Avoid excessive heat above 40ºC (104ºF)."],"package_label_principal_display_panel":["Bulk package Label label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Antihistamine"],"set_id":"2f7f078e-de04-9d53-e063-6394a90a409f","spl_product_data_elements":["Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate FD&C BLUE NO. 1 1,4-SORBITAN MICA ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN POLYETHYLENE GLYCOL 400 POVIDONE K30 D&C YELLOW NO. 10 SORBITOL GLYCERIN GELATIN TITANIUM DIOXIDE WATER DOXYLAMINE SUCCINATE DOXYLAMINE Glittering"],"stop_use":["Stop use and ask a doctor if • pain, cough, or nasal congestion 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. • nervousness, dizziness, or sleeplessness occurs"],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: • skin reddening • blisters • rash • hives • facial swelling • asthma (wheezing) • shock If a skin or general allergic 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."],"when_using":["When using this product do not exceed recommended dosage"]}