ZEPHREX-D (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WESTPORT PHARMACEUTICALS]

ZEPHREX-D (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WESTPORT PHARMACEUTICALS]
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NDC 53240-151-01
Set ID d327b4ea-a232-4102-bd74-141196f687e0
Category HUMAN OTC DRUG LABEL
Packager Westport Pharmaceuticals
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • 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

    Package Label

  • INGREDIENTS AND APPEARANCE
    ZEPHREX-D 
    pseudoephedrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53240-151
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    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)