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Sinus Congestion and Pain Relief Non-Drowsy

Medically reviewed on March 6, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: WinCo Foods, LLC
NDC Code: 67091-213

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Winco 44-466C

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg 

Purpose

Pain reliever/fever reducer
Nasal decongestant 

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion and pressure
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • temporarily reduces fever 

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product 

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical hep right away.

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have
  • high blood pressure
  • thyroid disease
  • liver disease
  • diabetes
  • heart disease
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin. 

When using this product

do not exceed recommended dosage. 

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition. 

If pregnant or breast-feeding,

ask a health professional before use. 

Keep out of reach of children.

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.

Directions
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor 

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide 

Questions?

Call 800-824-1706 Monday - Friday 9am - 4pm MST

Principal Display Panel

WinCo®
FOODS 

NON-DROWSY
Sinus Congestion
& Pain Relief

Daytime

*Compare to the active ingredients in TYLENOL® Sinus + Headache

Relieves: Sinus Headache,
Sinus Pressure
& Nasal Congestion

Cool Blast Flavor

ACETAMINOPHEN/
PAIN RELIEVER - FEVER REDUCER

PHENYLEPHRINE HCl/NASAL DECONGESTANT

24
Caplets

DISTRIBUTED BY:
WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed by MCNEIL CONSUMER HEALTHCARE, distributor of TYLENOL® Sinus + Headache.

50844      REV0316A46608     WF1612

100% SATISFACTION GUARANTEE
Comments & Questions? 800-824-1706

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 

Winco 44-466C

SINUS CONGESTION AND PAIN RELIEF  NON-DROWSY
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-213
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
CROSPOVIDONE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize17mm
FlavorMINTImprint Code44;466
Contains    
Packaging
#Item CodePackage Description
1NDC:67091-213-242 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/26/2005
Labeler - WinCo Foods, LLC (056098817)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(67091-213)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(67091-213)

 
WinCo Foods, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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