Label: PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 07/09

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

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 30 mg

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  • Purpose

    Nasal decongestant

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  • Uses

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • 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
    • thyroid disease
    • diabetes
    • 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

    • you get nervous, dizzy or sleepless
    • symptoms do not get better 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. (1-800-222-1222)

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  • 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 12 years
    • take 1 tablet every 4 to 6 hours
    • do not take more than 4 tablets in 24 hours
    children under 6 years do not use this product in children under 6 years of age
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  • Other information

    • each tablet contains: calcium 20 mg
    • store at 20°-25°C (68°-77°F)
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  • Inactive ingredients

    carnauba wax, dibasic calcium phosphate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to Sudafed® Nasal Decongestant active ingredient

    Pseudoephedrine Hydrochloride 30 mg

    Nasal Decongestant

    Maximum Strength

    Non-Drowsy

    Nasal & Sinus Congestion

    Sinus Pressure

    30 mg each

    See New Dosing Directions

    Actual Size

    Pseudoephedrine Hydrochloride 30 mg Carton

    Pseudoephedrine Hydrochloride 30 mg Carton

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  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45802-432
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    SILICON DIOXIDE  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED Score no score
    Shape ROUND (convex) Size 7mm
    Flavor Imprint Code L432
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45802-432-62 1 in 1 CARTON
    1 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/17/2008
    Labeler - Perrigo New York Inc (078846912)
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