{"active_ingredient":["Active ingredients (in each Softgel) Acetaminophen USP 325 mg Dextromethorphan Hydrobromide USP 10 mg Doxylamine succinate USP 6.25 mg Phenylephrine Hydrochloride USP 5 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease high blood pressure 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_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."],"dosage_and_administration":["Directions take only as directed do not exceed 8 Softgels per 24 hrs Adults & children 12 years & over 2 softgels with water every 4 hours Children 4 to under 12 years Ask a doctor Children under 4 years Do not use"],"dosage_and_administration_table":["
Adults & children 12 years & over2 softgels with water every 4 hours
Children 4 to under 12 yearsAsk a doctor
Children under 4 yearsDo not use
"],"effective_time":"20260128","id":"47c7e929-e897-88c0-e063-6394a90a5821","inactive_ingredient":["Inactive ingredients FD&C Blue No.1, D&C Yellow No.10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol sorbitan solution."],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation Cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores free breathing through the nose promotes nasal and/or sinus drainage"],"keep_out_of_reach_of_children":["Keep out of reach of children. Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["SOFTGEL HEALTHCARE PRIVATE LIMITED"],"package_ndc":["35916-0167-1"],"product_ndc":["35916-0167"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1297288"],"spl_id":["47c7e929-e897-88c0-e063-6394a90a5821"],"spl_set_id":["1fcbafaa-c871-db6d-e063-6394a90aab5e"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ","V9BI9B5YI2"],"upc":["0335916016716"]},"other_safety_information":["Other information Store at no greater than 25ºC"],"overdosage":["Overdosage 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."],"package_label_principal_display_panel":["carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine Nasal decongestant"],"set_id":"1fcbafaa-c871-db6d-e063-6394a90aab5e","spl_product_data_elements":["Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride D&C YELLOW NO. 10 GLYCERIN PROPYLENE GLYCOL GELATIN ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE WATER FD&C BLUE NO. 1 POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE DOXYLAMINE SUCCINATE DOXYLAMINE SORBITOL Transparent Oblong square"],"spl_unclassified_section":["TAMPER EVIDENT This package is safety-sealed. Use only if blisters are intact. If difficult to open, use scissors.","Manufactured by Softgel Healthcare Pvt. Ltd., Survey No. 20/1, Vandalur-Kelambakkam Road, Pudupakkam Village, Kancheepuram District, Tamilnadu - 603 103, India. Mfg. Lic. No.: XXXXXXXXXXXX"],"stop_use":["Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, 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."],"version":"3","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."],"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, & tranquilizers may increase drowsiness"]}