Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Phenlyephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Fsa Store Inc. (caring Mills) for the product Daytime Cold And Flu (NDC 81522-898). 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), 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
Dextromethoprhan HBr 10 mg
Phenlyephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
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.
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
FD&C yellow #6, FD&C red #40, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink
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**Compare to Vicks® Dayquil® Cold & Flu LiquiCaps® active ingredients
Daytime
Pain Reliever, Fever Reducer,
Cough Suppressant, Nasal Decongestant
Acetaminophen
Dextromethorphan HBr
Phenylephrine HCl
Cold & Flu
Daytime Relief
Softgels*
(*Liquid-filled capsules)
**This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil®, and LiquiCaps® are registered trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWING ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Manufactured for FSA Store Inc.
601 W 26th St, 3rd Floor
STE 357
DPT # 24075
New York, NY 10001
* Please review the disclaimer below.