Label: PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/12

If you are a consumer or patient please visit this version.

  • 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.

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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 59o to 77oF in a dry place
    • protect from light
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  • INACTIVE INGREDIENTS

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

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  • QUESTIONS?

    call 1-800-406-7984

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  • SPL UNCLASSIFIED SECTION

    Keep the Carton. It contains important information.

    See end panel for expiration date.

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

    Distributed by:

    Ohm Laboratories Inc.

    1385 Livingston Avenue

    North Brunswick, NJ 08902

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  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient of SUDAFED®12 HOUR.

    NDC 51660-492-21

    Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablets, USP

    Long-Acting Nasal Decongestant

    20Coated Capsule-Shaped Tablets

    120 mg Each

    12 Hour

    Nasal & Sinus Congestion due to Colds & Allergies

    Sinus Pressure

    This product is not manufactured or distributed by Johnson & Johnson Corporation, owner ofthe registered trademark SUDAFED® 12 HOUR.

    20's blister carton

    20's blister carton

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  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51660-492
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    CASTOR OIL  
    COLLOIDAL SILICON DIOXIDE  
    HYPROMELLOSES  
    CELLULOSE, MICROCRYSTALLINE  
    MAGNESIUM STEARATE  
    TITANIUM DIOXIDE  
    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:51660-492-21 20 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077442 04/28/2006
    Labeler - Ohm Laboratories Inc. (184769029)
    Registrant - Ohm Laboratories Inc. (184769029)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 051565745 manufacture
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