{"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":["
adults & children 12 yrs & over 2 softgels with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
"],"effective_time":"20231204","id":"ce37a50d-23c0-44b6-ac20-a59183987bcc","inactive_ingredient":["Inactive ingredients edible printing ink, FD&C blue no.1, FD&C red no.40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, 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 • 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":["TopCare Day Time SEVERE Cold and Flu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["76162-811-24"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["76162-811"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1656815"],"spl_id":["ce37a50d-23c0-44b6-ac20-a59183987bcc"],"spl_set_id":["14d53907-a4a2-4a0f-b2d6-33474945f9e1"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Packaging daytimecoldnflu"],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant"],"questions":["Questions or comments? Call 1-888-423-0139"],"set_id":"14d53907-a4a2-4a0f-b2d6-33474945f9e1","spl_product_data_elements":["TopCare Day Time SEVERE Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL SORBITAN 811"],"spl_unclassified_section":["Drug Facts","COMPARE TO VICKS ® DAYQUIL™ SEVERE COLD & FLU ACTIVE INGREDIENTS* MULTI-SYMPTOM RELIEF Antihistamine Free KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks® and DayQuil™. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING. QUALITY GUARANTEED DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO STVA0323 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com PRODUCT OF UNITED ARAB EMIRATES REV.01-042023 CT761628114"],"storage_and_handling":["Other information • store at 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 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. 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 • a sodium-restricted diet • 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."]}