{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg"],"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"],"dosage_and_administration_table":["<table width=\"50%\"><caption/><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"> adults &amp; children 12 yrs &amp; over</td><td styleCode=\"Botrule Lrule Rrule Toprule\"> 2 softgels with water every 4 hrs</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"> children 4 to under 12 yrs</td><td styleCode=\"Botrule Lrule Rrule Toprule\"> ask a doctor</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"> children under 4 yrs</td><td styleCode=\"Botrule Lrule Rrule Toprule\"> do not use</td></tr></tbody></table>"],"effective_time":"20251210","id":"b3dff6d2-e32d-4237-96de-cafcf66e4592","inactive_ingredient":["Inactive ingredients FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • minor aches & pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["DayTime SEVERE Cold and Flu Relief SOFTGELS"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["76162-636-24"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["76162-636"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1656815"],"spl_id":["b3dff6d2-e32d-4237-96de-cafcf66e4592"],"spl_set_id":["3ffe0f43-b92a-f947-e063-6394a90ab72c"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Packaging DaytimeSevereColdFluRelief"],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant"],"questions":["Questions or comments? Call 1-888-423-0139"],"set_id":"3ffe0f43-b92a-f947-e063-6394a90ab72c","spl_product_data_elements":["DayTime SEVERE Cold and Flu Relief SOFTGELS Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SORBITOL SORBITAN TITANIUM DIOXIDE A13"],"spl_unclassified_section":["Drug Facts","COMPARE TO VICKS ® DAYQUIL ™ SEVERE COLD & FLU LIQUICAPS™ ACTIVE INGREDIENTS* MULTI-SYMPTOM RELIEF Antihistamine Free READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION. DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO STVA0825 topcare@topco.com www.topcarebrand.com PRODUCT OF INDIA *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks ® , DayQuil™ and LiquiCaps™ . TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING."],"storage_and_handling":["Other information • store at controlled room temperature 20-25°C (68-77°F) • protect from light, heat and moisture"],"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. 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. Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin; taking sedatives ot tranquilizers. 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. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away."]}