Label: ZEPHREX D- pseudoephedrine hydrochloride capsule, gelatin coated

  • NDC Code(s): 0113-0401-62, 0113-0401-67
  • Packager: L. Perrigo Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 18, 2020

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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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