Label: PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated, extended release

  • NDC Code(s): 21130-204-21, 21130-204-69
  • Packager: Safeway Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 02/15

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  • ACTIVE INGREDIENT (IN EACH TABLET)

    Pseudoephedrine HCL, USP 120 mg

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  • PURPOSE

    Nasal decongestant

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  • USES

    Temporarily relieves nasal congestion due to:

    common cold
    hay fever
    upper respiratory allergies
    temporarily restores freer breathing through the nose
    promotes nasal and/or sinus drainage
    temporarily relieves sinus congestion and pressure
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  • 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
    diabetes
    thyroid disease
    trouble urinating due to an enlarged prostate gland

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    symptoms do not get better within 7 days or occur with a fever
    you get nervous, dizzy, or sleepless

    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).

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  • DIRECTIONS

    adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
    children under 12 years: ask a doctor
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  • OTHER INFORMATION

    store at 59° to 77° F in a dry place
    protect from light
    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
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  • INACTIVE INGREDIENTS

    Castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

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  • QUESTIONS?

    Call 1-888-723-3929

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  • PRINCIPAL DISPLAY PANEL

    NDC 21130-204-69

    12 HOUR MAXIMUM STRENGTH

    Pseudoephedrine Hydrochloride 120 mg

    Extended-Release Tablets, USP

    Long-Acting Nasal Decongestant

    Compare to SUDAFED®12 Hour active ingredient

    Nasal & Sinus Congestion Due to Colds or Allergies
    Sinus Pressure
    Non-Drowsy

    10 COATED CAPSULE SHAPED TABLETS 120 mg EACH

    SAFEWAY® care

    DISTRIBUTED BY SAFEWAY INC.

    5115098/0115

    This is the 20 count blister carton label for Safeway Pseudoephedrine HCl, 120 mg extended-release tablets, USP.
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  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-204
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    CASTOR OIL (UNII: D5340Y2I9G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code 204
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-204-21 20 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:21130-204-69 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077442 04/28/2006
    Labeler - Safeway Inc. (009137209)
    Registrant - Ohm Laboratories Inc. (184769029)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 051565745 MANUFACTURE(21130-204)
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