{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough 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."],"dosage_and_administration":["Directions take only as directed do not exceed 4 doses 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"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults &amp; children 12 yrs &amp; over</td><td>2 softgels with water every 4 hrs</td></tr><tr><td>children 4 to under 12 yrs</td><td>ask a doctor</td></tr><tr><td>children under 4 yrs</td><td><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20250210","id":"2dc3a685-34e1-0823-e063-6294a90ad27d","inactive_ingredient":["Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide."],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains 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 (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Daytime cold and flu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELS"],"is_original_packager":[true],"manufacturer_name":["TIME CAP LABORATORIES, INC."],"package_ndc":["49483-693-48"],"product_ndc":["49483-693"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086997"],"spl_id":["2dc3a685-34e1-0823-e063-6294a90ad27d"],"spl_set_id":["fd24653e-c4fa-3c09-e053-6394a90aaa9e"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE","ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["04JA59TNSJ","362O9ITL9D","9D2RTI9KYH"]},"other_safety_information":["Other information store at room temperature"],"package_label_principal_display_panel":["693T_49483-693_48ct_IFC"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions or comments? Call 1-877-290-4008"],"set_id":"fd24653e-c4fa-3c09-e053-6394a90aaa9e","spl_product_data_elements":["Daytime cold and flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI 325, 10, 5 mg softgels PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER ACETAMINOPHEN ACETAMINOPHEN FD&C RED NO. 40 FD&C YELLOW NO. 6 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN SORBITAN TITANIUM DIOXIDE GELATIN SHELLAC SORBITOL SOLUTION Oblong shaped capsule 70 Orange transparent colour"],"spl_unclassified_section":["Drug Facts Drug Facts"],"stop_use":["Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion 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 4 doses 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, lasts 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."]}