ZEPHREX D (PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]

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ZEPHREX D (PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [L. PERRIGO COMPANY]
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NDC 0113-0401-62, 0113-0401-67
Set ID 5468a7e2-361b-494f-9ca3-1b62f3819f65
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient (in each softgel)

    Pseudoephedrine HCl 30 mg

  • Purpose

    Nasal decongestant

  • 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 dosage

  • Stop use and ask a doctor if

    •
    nervousness, dizziness, or sleeplessness occurs
    •
    symptoms do not improve within 7 days or occur with a fever
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • 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).

  • Directions

    adults and children 12 years and over
    •
    take 2 softgels every 4 to 6 hours
    •
    do not take more than 8 softgels in 24 hours

    children ages 6 to under 12 years
    •
    take 1 softgel every 4 to 6 hours
    •
    do not take more than 4 softgels in 24 hours

    children under 6 years

    do not use this product in children under 6 years of age
  • Other information

    •
    store at 20-25°C (68-77°F)
    •
    do not use if blister unit is broken or torn
  • Inactive ingredients

    croscarmellose sodium, FD&C red no. 40, gelatin, guar gum, hydroxypropylcellulose, lecithin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water, sorbitan, sorbitol, titanium dioxide, vegetable oil, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    NEW DOSAGE FORM

    MAXIMUM STRENGTH

    ZEPHREX-D ®

    CONGESTION

    Pseudoephedrine HCl 30 mg

    Nasal Decongestant

    METH BLOCKING TAREX® TECHNOLOGY ™

    Non-Drowsy

    Relieves

    Nasal & Sinus Congestion

    Sinus Pressure

    Easy-to-take softgels.

    Individually sealed.

    Actual Size

    Fast-acting nasal decongestant goes to work in as little as 30 minutes. With advanced meth-blocking technology for safer communities.

    24 softgels

    Zephrex-D image
  • INGREDIENTS AND APPEARANCE
    ZEPHREX D 
    pseudoephedrine hydrochloride capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0401
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GUAR GUM (UNII: E89I1637KE)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code ZD3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0401-6224 in 1 CARTON04/17/2017
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0113-0401-6748 in 1 CARTON05/08/2017
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/04/2016
    Labeler - L. Perrigo Company (006013346)
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