ZEPHREX-D- pseudoephedrine hydrochloride tablet 
Westport Pharmaceuticals

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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Active Ingredients (in each pill)

Pseudoephedrine HCl 30 mg

Purpose

Nasal Decongestant

Keep out of reach of children. In case of overdose, get medical help or contact a

Poison Control Center right away. (1-800-222-1222)

Uses

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 • high blood pressure • thyroid disease • diabetes

• trouble urinating due to an enlarged prostate gland

When using this product do not exceed recommended dose

Stop and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Directions: remove pill from sealed, plastic packaging before ingesting

swallow whole – do not crush, chew or dissolve

adults and children 12 years and over • take 2 pills every 4 to 6 hours

• do not take more than 8 pills in 24 hours

children ages 6 to under 12 years • take 1 pill every 4 to 6 hours

• do not take more than 4 pills in 24 hours

children ages under 6 years do not use this product in children

under 6 years of age

Inactive Ingredients croscarmellose sodium, guar gum, hydroxypropyl cellulose, lecithin,

microcrystalline cellulose, polyethylene glycol, polysorbate 80, vegetable oil, xanthan gum

Package Label

ZEPHREX-D 
pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53240-151
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
GUAR GUM 
HYDROXYPROPYL CELLULOSE 
LECITHIN, SOYBEAN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 3350 
POLYSORBATE 80 
HYDROGENATED PALM KERNEL OIL 
XANTHAN GUM 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53240-151-0124 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/15/2012
Labeler - Westport Pharmaceuticals (078368047)
Registrant - Elge Inc. (610655136)
Establishment
NameAddressID/FEIBusiness Operations
Elge Inc.610655136manufacture(53240-151)

Revised: 5/2013
Document Id: af2ec66e-18ce-47da-a66f-887ceff6356e
Set id: d327b4ea-a232-4102-bd74-141196f687e0
Version: 8
Effective Time: 20130515
 
Westport Pharmaceuticals