{"active_ingredient":["Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg","Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough as occurs with smoking, asthma, or emphysema • a sodium-restricted diet","Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin","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. • if you have ever had an allergic reaction to this product or any of its ingredients","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 • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use","Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["
adults & children 12 yrs & over
30 mL every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
","
adults & children 12 yrs & over
30 mL every 4 hrs
children 6 to under 12 yrs
15 mL every 4 hrs
children 4 to under 6 yrs
ask a doctor
children under 4 yrs
do not use
"],"effective_time":"20260526","id":"4ec4eb9a-e323-4e7d-9fc4-8607cac3cb94","inactive_ingredient":["Inactive ingredients alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate","Inactive ingredients anhydrous citric acid, FD&C yellow no. 6, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum"],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever • runny nose and sneezing","Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • 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.","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 Day Time Nite Time Cold and Flu Relief"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"package_ndc":["36800-301-02","36800-459-40","36800-522-40"],"product_ndc":["36800-301"],"product_type":["HUMAN OTC DRUG"],"rxcui":["1042675","1043400","1113705","2604561","2687211"],"spl_id":["4ec4eb9a-e323-4e7d-9fc4-8607cac3cb94"],"spl_set_id":["c00ff684-acaf-4fbe-bc74-7e48751b927d"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel TopCare ® health COMPARE TO VICKS ® DAYQUIL ® and VICKS ® NYQUIL ® ACTIVE INGREDIENTS Cold & Flu Relief DAY & NIGHT COMBO PACK TopCare ® health COMPARE TO VICKS ® DAYQUIL ® ACTIVE INGREDIENTS MULTI-SYMPTOM RELIEF DayTime 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 ORIGINAL FLAVOR TopCare ® health COMPARE TO VICKS ® NYQUIL ® ACTIVE INGREDIENTS MULTI-SYMPTOM RELIEF NiteTime 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 10% CHERRY FLAVOR POWERFUL RELIEF DAY OR NIGHT 2 BOTTLES – 1 DAYTIME/1 NIGHTTIME 12 FL OZ (355 mL) EACH; TOTAL 24 FL OZ (1.5 pt) (710 mL) topcare-daytime-nighttime-cold-&-flu-relief-carton-image-1.jpg topcare-daytime-nighttime-cold-&-flu-relief-carton-image-2.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use.","If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Antihistamine","Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-888-423-0139","Questions or comments? 1-888-423-0139"],"set_id":"c00ff684-acaf-4fbe-bc74-7e48751b927d","spl_product_data_elements":["TopCare Day Time Nite Time Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl topcare nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ALCOHOL ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE, UNSPECIFIED FORM Clear/Dark Red Menthol Aroma topcare day time cold and flu relief multi symptom relief acetaminophen, dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 GLYCERIN MENTHOL, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SOLUTION SUCRALOSE XANTHAN GUM clear with fruit"],"spl_unclassified_section":["Nighttime Cold & Flu","Daytime Cold & Flu"],"stop_use":["Stop use and ask a doctor if • 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 • you get nervous, dizzy or sleepless • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • 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 • each 30 mL contains: sodium 36 mg • store at 20-25 ° C (68-77 ° F)","Other information • each 15 mL contains: sodium 15 mg • store at 20-25 ° C (68-77 ° F)"],"version":"6","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, 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. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough as occurs with smoking, asthma, or emphysema • a sodium-restricted diet Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • 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 Stop use and ask a doctor if • 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. 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.","Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin 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 5 days (children) or 7 days (adults) • 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 do not use more than directed"]}