NASAL DECONGESTANT PE- phenylephrine hcl tablet, coated 
Wal-Mart Stores Inc

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.

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Equate 44-453-Delisted

Active ingredients (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

  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged 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: do not use this product in children under 12 years of age 

Other information

  • 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, magnesiums stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions?

1-888-287-1915

Principal display panel

NDC 49035-453-23

equate®

Compare to Sudafed PE® Active Ingredient*

Maximum Strength
Nasal Decongestant PE
Phenylephrine HCl 10 mg
Non-Drowsy

Relieves:
• Sinus pressure
• Congestion

10 mg
72 TABLETS

Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716 ©Wal-Mart Stores, Inc.
 *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Sinus Headache.

50844        REV0313A45323

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

Equate 44-453

Equate 44-453

NASAL DECONGESTANT PE 
phenylephrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-453
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 44;453
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-453-231 in 1 CARTON
172 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/06/200411/18/2018
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(49035-453)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(49035-453)

Revised: 11/2015
Document Id: 469b107d-1d87-4bda-b8bf-ab088186f1c3
Set id: 18cdfcb9-6abd-4208-976c-927ab7f24c59
Version: 4
Effective Time: 20151118
 
Wal-Mart Stores Inc