NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET [CARDINAL HEALTH]

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NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET [CARDINAL HEALTH]
PDF | XML
NDC 70000-0135-1, 70000-0135-2
Set ID c2ad146c-f74e-486e-948e-c0a6b419f9ff
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient (in each tablet)

    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

    • diabetes
    • heart disease
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland

    When using this product

    do not exceed recommended dose.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with 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 (1-800-222-1222) right away.

  • Directions

    adults and children 12 years and oldertake 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
    children ages 6 to 12 yearstake 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
    children under 6 yearsdo not use this product in children under 6 years of age

  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

  • Questions or comments?

    1-800-426-9391
  • Principal Display Panel

    NDC 70000-0135-2

    LEADER™

    Maximum Strength
    Nasal Decongestant
    Pseudoephedrine HCl, 30 mg | Nasal Decongestant

    Non-Drowsy
    Nasal & Sinus Congestion
    Sinus Pressure

    96 TABLETS
    ACTUAL SIZE

    COMPARE TO SUDAFED®
    MAXIMUM STRENGTH CONGESTION
    active ingredient*

    100% Money Back Guarantee

    TAMPER EVIDENT: DO NOT USE IF
    CARTON IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS
    ANY SIGNS OF TAMPERING

    * This product is not manufactured or distributed by Johnson
    & Johnson Corporation, owner of the registered trademark
    Sudafed® Maximum Strength Congestion.  50844      ORG071211246

    CardinalHealth™
    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017

    www.myleader.com 1-800-200-6313
    Essential to Care™ since 1979

    All LEADER™ Brand Products Have A
    100% Money Back Guarantee

    Return to place of purchase if not satisfied.

    ©2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,
    the Cardinal Health LOGO, LEADER, and the Leader LOGO are
    trademarks or registered trademarks of Cardinal Health.

    Leader 44-112

    Leader 44-112

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT  MAXIMUM STRENGTH
    pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0135
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;112
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0135-11 in 1 CARTON08/25/1981
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70000-0135-24 in 1 CARTON08/25/198102/04/2022
    224 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/25/1981
    Labeler - Cardinal Health (097537435)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(70000-0135)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(70000-0135)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(70000-0135)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(70000-0135)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(70000-0135)
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