{"active_ingredient":["Active ingredients (in each softgel) – Nitetime Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg"],"ask_doctor":["Ask a doctor before use if you have – Nighttime Cold & Flu • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough as occurs with smoking, asthma, or emphysema • trouble urinating due to an enlarged prostate gland","Ask a doctor before use if you have – Daytime Cold & Flu • liver disease • diabetes • heart disease • high blood pressure • thyroid disease • trouble urinating due to an 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 – Nighttime Cold & Flu • taking sedatives or tranquilizers • taking the blood thinning drug warfarin","Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu 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. • if you have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions – Nitetime Cold & Flu • take only as directed – see overdose warning • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use","Directions – Daytime Cold & Flu • take only as directed – see overdose warning • 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":["
adults & children 12 yrs & over
2 softgels with water every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
","
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
"],"effective_time":"20241114","id":"58aafd33-e288-483d-82c0-edd3ac369c60","inactive_ingredient":["Inactive ingredients – Nitetime Cold & Flu D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient","Inactive ingredients – Daytime Cold & Flu edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient"],"indications_and_usage":["Uses – Nitetime Cold & Flu temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • minor aches and pains • sore throat • headache • runny nose and sneezing • fever","Uses – Daytime Cold & Flu temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • minor aches and pains • sore throat • headache • nasal congestion • fever"],"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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Topcare Nite Time Day Time Cold and Flu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"package_ndc":["36800-580-72","36800-143-73"],"product_ndc":["36800-580"],"product_type":["HUMAN OTC DRUG"],"rxcui":["1086997","1094549","2634564"],"spl_id":["58aafd33-e288-483d-82c0-edd3ac369c60"],"spl_set_id":["efb8e0e2-0795-4f4a-8ca6-955f33bee143"]},"package_label_principal_display_panel":["Principal Display Panel - Daytime SPECIAL VALUE! COMBINATION PACK Top Care ® health COMPARE TO VICKS ® DAYQUIL ® COLD & FLU ACTIVE INGREDIENTS MULTI-SYMPTOM RELIEF Day Time Cold & Flu Relief PAIN RELIEVER – FEVER REDUCER - ACETAMINOPHEN COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr NASAL DECONGESTANT - PHENYLEPHRINE HCl • Headache, Fever, Sore Throat, Minor Aches & Pains • Nasal Congestion • Cough Alcohol Free Antihistamine Free Non-Drowsy actual size 32 SOFTGELS Top Care ® health COMPARE TO VICKS ® NYQUIL ® COLD & FLU ACTIVE INGREDIENTS MULTI-SYMPTOM RELIEF Nite Time Cold & Flu Relief PAIN RELIEVER – FEVER REDUCER - ACETAMINOPHEN COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr ANTIHISTAMINE - DOXYLAMINE SUCCINATE • Headache, Fever, Sore Throat, Minor Aches & Pains • Sneezing, Runny Nose • Cough Alcohol Free actual size 16 SOFTGELS Daytime Nighttime Cold and Flu Relief Image 1 Daytime Nighttime Cold and Flu Relief Image 2"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose – Nitetime Cold & Flu Pain reliever/fever reducer Cough suppressant Antihistamine","Purpose – Daytime Cold & Flu Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-888-423-0139"],"set_id":"efb8e0e2-0795-4f4a-8ca6-955f33bee143","spl_product_data_elements":["Topcare Nite Time Day Time Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl topcare nite time cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN clear 056 topcare day time Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN L994"],"spl_unclassified_section":["Active ingredients (in each softgel) – Daytime Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg"],"stop_use":["Stop use and ask a doctor if – Nighttime Cold & Flu • pain 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.","Stop use and ask a doctor if – Daytime Cold & Flu • 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."],"storage_and_handling":["Other information • store at 20-25 ° C (68-77 ° F)"],"version":"7","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • 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. 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. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have – Nighttime Cold & Flu • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough as occurs with smoking, asthma, or emphysema • trouble urinating due to an enlarged prostate gland Ask a doctor before use if you have – Daytime Cold & Flu • liver disease • diabetes • heart disease • high blood pressure • thyroid disease • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu • taking sedatives or tranquilizers • taking the blood thinning drug warfarin Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu taking the blood thinning drug warfarin When using this product • 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 When using this product – Daytime Cold & Flu do not use more than directed Stop use and ask a doctor if – Nighttime Cold & Flu • pain 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. Stop use and ask a doctor if – Daytime Cold & Flu • 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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product • 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","When using this product – Daytime Cold & Flu do not use more than directed"]}