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← See all Nasal Decongestant PE Maximum Strength brands

Nasal Decongestant PE Maximum Strength

Medically reviewed on Apr 21, 2018

Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: WinCo Foods, LLC
NDC Code: 67091-207

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 44-453

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg 

Purpose

Nasal decongestant 

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure 

Warnings

Do not use

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.

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

When using this product

do not exceed recommended dose. 

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur 
  • symptoms do not improve within 7 days or occur with fever

If pregnant or breast-feeding,

ask a health professional before use. 

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Directions
  • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets 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

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide 

Questions?

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

Principal Display Panel

WinCo®
FOODS

MAXIMUM STRENGTH 
Nasal
Decongestant PE

*Compare to the active ingredient in SUDAFED PE®

Non-Drowsy

Relieves: Sinus Pressure
& Nasal Congestion

PHENYLEPHRINE HCl 10 mg/
NASAL DECONGESTANT

18
Tablets

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

*This product is not manufactured or distributed by MCNEIL CONSUMER HEALTHCARE, distributor of SUDAFED PE®.

50844    REV0715A45344     WF1612

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

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

Winco 44-453


NASAL DECONGESTANT PE  MAXIMUM STRENGTH
phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-207
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
DEXTROSE MONOHYDRATE 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
TITANIUM DIOXIDE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
LECITHIN, SOYBEAN 
SILICON DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
TRISODIUM CITRATE DIHYDRATE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code44;453
Contains    
Packaging
#Item CodePackage Description
1NDC:67091-207-181 BLISTER PACK in 1 CARTON
118 TABLET in 1 BLISTER PACK
2NDC:67091-207-723 BLISTER PACK in 1 CARTON
224 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/14/2005
Labeler - WinCo Foods, LLC (056098817)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(67091-207)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(67091-207)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(67091-207)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(67091-207)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(67091-207)

 
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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