Zephrex-D

Dosage form: tablet
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Westport Pharmaceuticals
NDC Code: 53240-151

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.

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

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

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.

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

ZEPHREX-D 
pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:53240-151-0124 TABLET 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/FEIOperations
Elge Inc.610655136manufacture(53240-151)

Revised: 05/2013
 
Westport Pharmaceuticals

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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