{"active_ingredient":["Active ingredients (in each softgelatin capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg"],"ask_doctor":["Ask a doctor before use if you have ● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● cough 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":"20260427","id":"5003542f-a0ff-cd67-e063-6294a90aee97","inactive_ingredient":["Inactive ingredients FD&C yellow no.5, FD&C yellow no.6, 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 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Softgel Healthcare Private Limited"],"package_ndc":["35916-0188-1","35916-0188-2","35916-0188-3","35916-0188-4"],"product_ndc":["35916-0188"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086997"],"spl_id":["5003542f-a0ff-cd67-e063-6294a90aee97"],"spl_set_id":["30ab39f3-27cc-5728-e063-6394a90a9cbe"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE","DEXTROMETHORPHAN HYDROBROMIDE","ACETAMINOPHEN"],"unii":["04JA59TNSJ","9D2RTI9KYH","362O9ITL9D"]},"other_safety_information":["Other information ● store at room temperature. Avoid excessive heat above 40ºC (104ºF)."],"package_label_principal_display_panel":["bulk-label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"set_id":"30ab39f3-27cc-5728-e063-6394a90a9cbe","spl_product_data_elements":["Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl FD&C YELLOW NO. 6 WATER SORBITAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE MICA POLYETHYLENE GLYCOL 400 GLYCERIN SORBITOL TITANIUM DIOXIDE POVIDONE K30 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GELATIN FD&C YELLOW NO. 5 ACETAMINOPHEN ACETAMINOPHEN Glitter"],"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":"5","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"]}