NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [H E B]

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NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [H E B]
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NDC 37808-112-22
Set ID 22d241c5-a3fd-4619-8147-91d7a4c8cf98
Category HUMAN OTC DRUG LABEL
Packager H E B
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
    • difficulty in urination due to enlargement of the prostate gland

    When using this product

    do not exceed recommended dosage. 

    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 right away.

  • Directions

    adults and children
    12 years and over    		take 2 tablets every 4 to 6 hours;
    do not take more than 8 tablets
    in 24 hours
    children ages
    6 to 11 years    		take 1 tablet every 4 to 6 hours;
    do not take more than 4 tablets
    in 24 hours
    children under 6 yearsdo not use
  • Other information

    • each tablet contains: calcium 15 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Compare to Sudafed®  Sinus Congestion active ingredient*

    NDC 37808-112-22

    H - E - B ®

    Maximum Strength
    Nasal Decongestant

    Pseudoephedrine HCl 30 mg /
    Nasal Decongestant

    Sinus Pressure & Congestion

    Non-Drowsy 

    Relief of:
    • Nasal & Sinus Congestion
    • Sinus Pressure

    actual size

    48 TABLETS, 30 mg EACH

    TAMPER EVIDENT: DO NOT USE IF PACKAGE 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® Sinus Congestion.
    50844     REV0619A11222    

    DOES NOT CONTAIN GLUTEN

    100%
    GUARANTEE
    promise

    If you aren't completely pleased
    with this product, we'll be happy to
    replace it or refund your money.
    You have our word on it.

    MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

     

    HEB 44-112

    HEB 44-112

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    pseudoephedrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-112
    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
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;112
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-112-222 in 1 CARTON08/25/1981
    124 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 - H E B (007924756)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(37808-112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(37808-112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(37808-112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(37808-112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(37808-112)
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