Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine Succinate 6.25 mg
Phenylephrine HCl 5 mg
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Nite Time Cold And Flu (NDC 76162-202). 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 15 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine Succinate 6.25 mg
Phenylephrine HCl 5 mg
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Expectorant
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
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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
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, persists 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
These could be signs of a serious condition.
These could be signs of a serious condition.
ask a health professional before use.
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.
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 | 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 |
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 |
anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum
anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum
1-888-423-0139
1-888-423-0139
TopCare® health
COMPARE TO VICKS® DAYQUIL® SEVERE HONEY FLAVOR and VICKS® NYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS
Honey Flavor Cold & Flu Relief
DAY & NIGHT COMBO PACK
TopCare® health
COMPARE TO VICKS® DAYQUIL® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS
MAXIMUM STRENGTH RELIEF
DayTime Cold & Flu
SEVERE
PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN
NASAL DECONGESTANT – PHENYLEPHRINE HCl
COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr
EXPECTORANT - GUAIFENESIN
• Headache, Fever, Sore Throat, Minor Aches & Pains
• Nasal/Sinus Congestion & Sinus Pressure
• Thins & Loosens Mucus
• Chest Congestion
• Cough
Non-Drowsy
TopCare® health
COMPARE TO VICKS® SEVERE HONEY FLAVOR ACTIVE INGREDIENTS
MAXIMUM STRENGTH RELIEF
NiteTime Cold & Flu
SEVERE
PAIN RELIEVER/FEVER REDUCER – ACETAMINOPHEN
NASAL DECONGESTANT – PHENYLEPHRINE HCl
ANTIHISTAMINE – DOXYLAMINE SUCCINATE
COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr
• Headache, Fever, Sore Throat, Minor Aches & Pains
• Nasal/Sinus Congestion & Sinus Pressure
• Sneezing, Runny Nose
• Cough
HONEY 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)
* Please review the disclaimer below.