SUPHEDRINE PE- phenylephrine hcl tablet, film 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 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

  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed recommended dosage.

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 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, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions or comments?

1-888-287-1915

Principal display panel

NDC 49035-354-23

equate™

Compare to Sudafed PE® Congestion Active Ingredient*

Congestion
Suphedrine PE
Phenylephrine HCl Tablets,10 mg
Nasal Decongestant

Non-Drowsy

Relieves:
• Sinus Pressure
• Congestion

Maximum Strength

10 mg EACH     72 TABLETS

Actual Size

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed PE® Congestion.

50844        REV0118B45323

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

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments nor to report an undesired reaction or side effect, please call 1-888-287-1915.

44-453

44-453


SUPHEDRINE PE 
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-354
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 44;453
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-354-233 in 1 CARTON01/14/200511/24/2023
1NDC:49035-354-4324 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/14/200511/24/2023
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(49035-354)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(49035-354)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(49035-354)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(49035-354)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(49035-354)

Revised: 8/2022
 
Wal-Mart Stores Inc