{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg","Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 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","Directions • take only as directed • do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["<table width=\"40%\"><tbody><tr><td styleCode=\"Lrule Rrule Botrule\" valign=\"top\"> adults &amp; children 12 yrs &amp; over</td><td styleCode=\"Rrule Botrule\"> 2 softgels with water  every 4 hrs</td></tr><tr><td styleCode=\"Lrule Rrule Botrule\"> children 4 to under 12 yrs</td><td styleCode=\"Rrule Botrule\"> ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule Botrule\"> children under 4 yrs</td><td styleCode=\"Rrule Botrule\"> do not use</td></tr></tbody></table>","<table width=\"40%\"><tbody><tr><td styleCode=\"Botrule Lrule Rrule\" valign=\"top\"> adults &amp; children 12 yrs &amp; over</td><td styleCode=\"Botrule Rrule\"> 2 softgels with water  every 4 hours</td></tr><tr><td styleCode=\"Botrule Lrule Rrule\"> children 4 to under 12 yrs</td><td styleCode=\"Botrule Rrule\"> ask a doctor</td></tr><tr><td styleCode=\"Botrule Lrule Rrule\"> children under 4 yrs</td><td styleCode=\"Botrule Rrule\"> do not use</td></tr></tbody></table>"],"effective_time":"20231106","id":"1cf9fc29-a15e-4aa0-b169-7eab1ff6d123","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","Inactive ingredients edible printing ink, FD&C blue no. 1, 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.","Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • minor aches & pains • headache • fever • sore throat • runny nose & sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage"],"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.","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":["Cold and Flu Severe Daytime/Nighttime"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"package_ndc":["76162-823-12"],"product_ndc":["76162-823"],"product_type":["HUMAN OTC DRUG"],"rxcui":["1297288","1656815","2634364"],"spl_id":["1cf9fc29-a15e-4aa0-b169-7eab1ff6d123"],"spl_set_id":["27ade5f8-2003-4dc6-9244-42676791e1f8"]},"package_label_principal_display_panel":["Packaging Topco-823 Topco-823"],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant","Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant"],"questions":["Questions or Comments? Call 1-888-423-0139","Questions or comments? Call 1-888-423-0139"],"set_id":"27ade5f8-2003-4dc6-9244-42676791e1f8","spl_product_data_elements":["Cold and Flu Severe Daytime/Nighttime Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate 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 TopCare Nite Time SEVERE Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL SORBITAN 812"],"spl_unclassified_section":["DAY TIME SEVERE COLD AND FLU RELIEF Drug Facts","NITE TIME SEVERE COLD AND FLU RELIEF Drug Facts","COMBINATION PACK COMPARE TO VICKS ® DAYQUIL ™ SEVERE COLD & FLU ACTIVE INGREDIENTS* COMPARE TO VICKS ® NYQUIL ™ SEVERE COLD & FLU ACTIVE INGREDIENTS* MULTI-SYMPTOM RELIEF Antihistamine Free DO NOT TAKE THESE PRODUCTS AT THE SAME TIME TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. *These products are not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks ® DayQuil ® & NyQuil ® Severe DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO STVA0323 topcare@topco.com www.topcarebrand.com PRODUCT OF UNITED ARAB EMIRATES QUALITY GUARANTEED This TopCare ® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed. REV.01-042023"],"storage_and_handling":["Other information • store at 20-25°C (68-77°F) • protect from light, heat and moisture","Other information • store at 20-25°C (68-77°F) • protect from light, heat and moisture"],"version":"1","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 • 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.","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) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin 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, and tranquilizers may increase drowsiness 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."]}