Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Nighttime Cold And Flu Relief (NDC 59779-335). 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 30 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 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 | 30 mL every 6 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
1-800-719-9260
Compare to active the ingredients in Vicks® NyQuil® Cold & Flu
Cold/Flu
Multi-Symptom
Nighttime
COLD & FLU RELIEF
Powerful Nighttime Relief
ACETAMINOPHEN
Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr
Cough suppressant
DOXYLAMINE SUCCINATE
Antihistamine
Relieves:
Aches; Fever; Cough; Sore throat; Sneezing; Runny nose
Original Flavor
ALCOHOL 10%
12 FL OZ (355 mL)
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