{"active_ingredient":["Active ingredients (in each softgelatin capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis 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."],"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 4 hrs children 4 to under 12 yrs : ask a doctor children under 4 yrs : do not use"],"effective_time":"20260803","id":"5821ad21-a279-cbd8-e063-6394a90ada5f","inactive_ingredient":["Inactive ingredients FD&C blue no. 40, FD&C Yellow no.6, gelatin, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, purified water, sorbitol sorbitan solution"],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat minor aches & pains headache 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":["Acetominophen, Dextromethorphan hydrobromide"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["Softgel Healthcare Private Limited"],"package_ndc":["35916-2211-1"],"product_ndc":["35916-2211"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1867684"],"spl_id":["5821ad21-a279-cbd8-e063-6394a90ada5f"],"spl_set_id":["5302bc6d-d947-31c3-e063-6294a90a09f3"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","ACETAMINOPHEN"],"unii":["9D2RTI9KYH","362O9ITL9D"]},"other_safety_information":["Other information Store at 20-25 ºC (68-77ºF)"],"package_label_principal_display_panel":["aceto-dextro"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/Fever reducer Cough suppressant"],"set_id":"5302bc6d-d947-31c3-e063-6294a90a09f3","spl_product_data_elements":["Acetominophen, Dextromethorphan hydrobromide Acetaminophen, Dextromethorphan hydrobromide DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN PROPYLENE GLYCOL FD&C RED NO. 40 FD&C YELLOW NO. 6 WATER SORBITAN POLYETHYLENE GLYCOL 400 GLYCERIN SORBITOL POVIDONE K30 GELATIN Transparent Oblong 37"],"stop_use":["Stop use and ask a doctor if pain or cough get worse or last 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":"2","warnings":["Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels 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."],"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"]}