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 Bi-mart for the product Cold And Flu (NDC 37835-524). 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
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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose
1-800-935-6737
BI-MART
Compare to the active ingredients in Vicks® NyQuil® Cold & Flu Nighttime Relief*
NIGHTTIME
COLD & FLU
Acetaminophen (Pain reliever/fever reducer)
Dextromethorphan HBr (Cough suppressant)
Doxylamine succinate (Antihistamine)
Multi-Symptom Relief
• Aches, Fever & Sore Throat
• Cough
• Sneezing, Runny Nose
Alcohol Free
12 FL OZ (354 mL)
TAMPER EVIDENT: DO NOT USE IS PRINTED NECK WRAP IS BROKEN OR MISSING
•This product is not manufactured or distributed by Procter & Gamble distributor of Vicks® NyQuil® Cold & Flu Nighttime Relief.
50844 ORG031801402
Distributed by:
BI-MART
Eugene, OR 97402
* Please review the disclaimer below.