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Suphedrine PE by Wal-Mart Stores Inc

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 4mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-462

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.

Equate 44-462

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Phenylephrine HCl 10 mg

Purpose

Antihistamine
Nasal decongestant

Uses
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • sinus congestion and pressure
    • nasal congestion 

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
  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a 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, lactose, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

Questions or comments?

1-888-287-1915

Principal display panel

equate™

NDC 49035-462-08

Compare to Sudafed PE® Sinus + Allergy Active Ingredients*

Sinus & Allergy

Suphedrine PE

Chlorpheniramine maleate and Phenylephrine HCl
Antihistamine, Nasal Decongestant

Relieves:
• Sinus pressure & congestion
• Sneezing, itchy eyes & runny nose

Maximum Strength

24 TABLETS

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Sinus + Allergy.
50844    ORG061246208

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

Equate 44-462

SUPHEDRINE PE 
chlorpheniramine maleate and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-462
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize6mm
FlavorImprint Code44;462
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-462-081 BLISTER PACK in 1 CARTON
124 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/09/2005
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(49035-462)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(49035-462)

Revised: 05/2014
 
Wal-Mart Stores Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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