ZEPHREX-D- pseudoephedrine hydrochloride tablet

Zephrex-D by

Drug Labeling and Warnings

Zephrex-D by is a Otc medication manufactured, distributed, or labeled by Westport Pharmaceuticals, Elge Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each pill)

Pseudoephedrine HCl 30 mg

PURPOSE

Purpose

Nasal Decongestant

KEEP OUT OF REACH OF CHILDREN

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)

INDICATIONS & USAGE

Uses

• temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
• temporarily relieves sinus congestion and pressure

WARNINGS

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

• 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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZEPHREX-D 
pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53240-151
Route of Administration	ORAL

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)