Active Ingredients (In Each Softgel) – Nighttime Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Nite Time Day Time (NDC 36800-580). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each softgel) – nighttime cold & flu, active ingredients (in each softgel) – daytime cold & flu, purpose – nighttime cold & flu, purpose – daytime cold & flu, uses – nighttime cold & flu, uses – daytime cold & flu, warnings, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
temporarily relieves common cold/flu symptoms:
temporarily relieves common cold/flu symptoms:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
taking the blood thinning drug warfarin
do not use more than directed
ask a health professional before use.
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.
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 |
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
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
1-888-423-0139
SPECIAL VALUE! COMBINATION PACK
SEE NEW WARNINGS
MULTI-SYMPTOM RELIEF
Day Time Cold & Flu Relief
Pain Reliever – Fever Reducer
Acetaminophen
Cough Suppressant
Dextromethorphan HBr
Nasal Decongestant
Phenylephrine HCl
ALCOHOL FREE / ANTIHISTAMINE FREE
actual size
COMPARE TO VICKS® DAYQUIL® active ingredients
Non-Drowsy
32 SOFTGELS
SPECIAL VALUE! COMBINATION PACK
SEE NEW WARNINGS
MULTI-SYMPTOM RELIEF
Nite Time Cold & Flu Relief
Pain Reliever – Fever Reducer
Acetaminophen
Cough Suppressant
Dextromethorphan HBr
Antihistamine
Doxylamine Succinate
ALCOHOL FREE
actual size
COMPARE TO VICKS® NYQUIL® active ingredients
16 SOFTGELS
* Please review the disclaimer below.