Label: ZEPHREX-D- pseudoephedrine hydrochloride tablet

  • NDC Code(s): 53240-151-01
  • Packager: Westport Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/13

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  • ACTIVE INGREDIENT

    Active Ingredients (in each pill)

    Pseudoephedrine HCl 30 mg

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  • PURPOSE

    Purpose

    Nasal Decongestant

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  • 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)

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  • 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

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  • 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.

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  • 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

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  • INACTIVE INGREDIENT

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

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

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  • INGREDIENTS AND APPEARANCE
    ZEPHREX-D 
    pseudoephedrine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53240-151
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    GUAR GUM  
    HYDROXYPROPYL CELLULOSE  
    LECITHIN, SOYBEAN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 3350  
    POLYSORBATE 80  
    HYDROGENATED PALM KERNEL OIL  
    XANTHAN GUM  
    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)
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