Your browser does not support JavaScript! WAL-PHED (PSEUDOEPHEDRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET [WALGREEN CO.]
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RxNorm Names

WAL-PHED (pseudoephedrine hcl, chlorpheniramine maleate) tablet
[Walgreen Co.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredients

(in each tablet)

Chlorpheniramine maleate 4 mg

Pseudoephedrine HCl 60 mg

Purpose

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • nasal congestion
  • itchy, watery eyes
  • itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing
  • 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

  • a breathing problem such as emphysema or chronic bronchitis
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • difficulty in urination due to enlargement of prostate gland

Ask a doctor of pharmacist before use if you are

taking tranquilizers or sedatives

When using this product

  • do not use more than directed
  • drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • 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
  • symptoms are accompanied by 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

  • do not exceed 4 doses in 24 hours
adults and children 12 years and older1 tablet every 4 to 6 hours
children 6 to under 12 years of age1/2 tablet every 4 to 6 hours
children under 6 years of ageconsult a doctor

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F) in a dry place and protect from light
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

Questions or comments?

1-800-426-9391

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Walgreens

NDC 0363-0111-22

MAXIMUM STRENGTH

WAL-PHED®

Chlorpheniramine Maleate 4 mg, Pseudoephedrine HCl 60 mg

Antihistamine, Nasal Decongestant

SINUS & ALLERGY

Relieves:

● Sneezing, Itchy/Watery Eyes

● Sinus Pressure ● Nasal & Sinus Congestion

48 DOSES, 1 Pill Per Dose

TABLETS

48 TABLETS

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

50844     REV0609H11122

Distributed by: Walgreen Co.,

200 Wilmot Rd., Deerfield, IL 60015-4616

Product Label
WAL-PHED  
pseudoephedrine hcl, chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride60 mg
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate4 mg
Inactive Ingredients
Ingredient NameStrength
Croscarmellose Sodium 
Magnesium Stearate 
Cellulose, Microcrystalline 
Silicon Dioxide 
Stearic Acid 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code 44;111
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0111-221 in 1 AMPULE
148 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/16/1992
Labeler - Walgreen Co. (008965063)
Registrant - L.N.K. International, Inc. (832867837)
Establishment
NameAddressID/FEIBusiness Operations
L.N.K. International, Inc832867894MANUFACTURE

Revised: 8/2010
 
Walgreen Co.

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