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 Type HUMAN OTC DRUG Item Code (Source) NDC:53240-151
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
GUAR GUM (UNII: E89I1637KE)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53240-151-01 24 in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/15/2012
Labeler - Westport Pharmaceuticals (078368047)
Registrant - Elge Inc. (610655136)
Establishment
Name Address ID/FEI Business Operations
Elge Inc. 610655136 manufacture(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