{"active_ingredient":["Active ingredients (in each softgels) Acetaminophen, USP 325 mg Dextromethorphan Hydrobromide, USP 10 mg Phenlyephrine Hydrochloride, USP 5 mg"],"dosage_and_administration":["Direction take only as directed do not exceed 4 doses per 24 hours adults and children 12 years and over take 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":["<table width=\"100%\"><caption/><tbody><tr><td><content styleCode=\"bold\">adults and children 12 years and over</content></td><td>take 2 softgels with water every 4 hours</td></tr><tr><td><content styleCode=\"bold\">children 4 to under 12 years</content></td><td>ask a doctor</td></tr><tr><td><content styleCode=\"bold\">children under 4 years</content></td><td>do not use</td></tr></tbody></table>"],"effective_time":"20250924","id":"3f86a539-828a-a6d3-e063-6294a90ab8c2","inactive_ingredient":["Inactive ingredients FD&C red #40, FD&C yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution."],"indications_and_usage":["Uses Temporarily relieves common cold and flu symptoms: nasal congestion cough due to minor throat and bronchial irritation headache minor aches and pains fever sore throat"],"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 (1-800-222-122) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Health Pharma USA LLC"],"package_ndc":["71679-101-00"],"product_ndc":["71679-101"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086997"],"spl_id":["3f86a539-828a-a6d3-e063-6294a90ab8c2"],"spl_set_id":["a03befb4-d86d-43e4-8097-eda5c8bb25be"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"]},"other_safety_information":["Other information store at room temperature. DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 1"],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions? call toll-free 1-844-832-1138"],"set_id":"a03befb4-d86d-43e4-8097-eda5c8bb25be","spl_product_data_elements":["Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL SOLUTION SORBITAN ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Oblong CF01"],"spl_unclassified_section":["If pregnant or breast-feeding, ask a health professional before use."],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses 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. Do not use with any other drug containing acetaminophen (prescription or non-prescription). 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 Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product, do not use more than directed. 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."]}