Label: EQUATE SUPHEDRINE- pseudoephedrine hydrochloride tablet, film coated, extended release

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

Drug Label Information

Updated 11/11

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

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 120 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, and nasal congestion associated with sinusitis
    • 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

    • high blood pressure
    • heart disease
    • 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

    • you get nervous, dizzy, or sleepless
    • symptoms do not improve within 7 days or are accompanied by 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.

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  • Directions

    • adults and children 12 years of age and over: one tablet every 12 hours not to exceed two tablets in 24 hours
    • children under 12 years of age: use of product not recommended
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  • Other information

    • each tablet contains: calcium 45 mg
    • store at 20° - 25°C (68° - 77°F) in a dry place
    • protect from light
    • do not use if blister unit is broken or torn
    • see carton end panel for lot number and expiration date
    • this product meets the requirements of USP Drug Release Test 3
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  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

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  • Questions or comments?

    1-888-287-1915

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  • Principal Display Panel

    Compare to Sudafed® 12 Hour Active Ingredient

    Non-Drowsy

    Suphedrine

    Pseudoephedrine Hydrochloride Extended-Release Tablets 120 mg

    12 HOUR

    Long-Acting Nasal Decongestant

    12 HOUR

    Relieves:

    Nasal and sinus congestion due to colds and allergies

    Sinus pressure

    *Capsule-Shaped Tablets

    120 mg EACH

    Actual Size

    Suphedrine Carton Image 1

    Suphedrine Carton Image 1

    Suphedrine Carton Image 2

    Suphedrine Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    EQUATE SUPHEDRINE 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-054
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code L054
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-054-60 2 in 1 CARTON
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075153 07/19/2000
    Labeler - Wal-Mart Stores Inc (051957769)
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