Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Nasal Decongestant Pe And Pain Relief (NDC 67091-209). 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 caplet), 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
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Nasal decongestant
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours. 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.
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.
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.
corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silica gel, stearic acid
Call 800-824-1706 Monday - Friday 9am - 4pm MST
WinCo®
FOODS
MAXIMUM STRENGTH
Nasal
Decongestant PE
& Pain Relief
*Compare to the active ingredients in SUDAFED PE® Pressure + Pain
Non-Drowsy
Relives: Sinus Headache,
Sinus Pressure
& Nasal Congestion
ACETAMINOPHEN/
PAIN RELIEVER - FEVER REDUCER
PHENYLEPHRINE HCl/NASAL DECONGESTANT
24
Caplets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
*This product is not manufactured or distributed by MCNEIL CONSUMER HEALTHCARE, distributor of SUDAFED PE® Pressure + Pain.
50844 REV0915A50208 WF1612
100% SATISFACTION GUARANTEE
Comments & Questions? 800-824-1706
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