Label: EQUATE SUPHEDRINE PE- phenylephrine hydrochloride tablet

  • NDC Code(s): 49035-131-68, 49035-131-89
  • Packager: Wal-Mart Stores Inc
  • 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 05/14

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

  • Active ingredient (in each tablet)

    Phenylephrine HCl 10 mg

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  • Purpose

    Nasal decongestant

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  • Uses

    temporarily relieves sinus congestion and pressure
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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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
    trouble urinating due to an enlarged prostate gland
    diabetes

    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. (1-800-222-1222)

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  • Directions

    adults and children 12 years and over

    take 1 tablet every 4 hours
    do not take more than 6 tablets in 24 hours

    children under 12 years

    do not use this product in children under 12 years of age

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  • Other information

    store at 20º-25ºC (68º-77ºF)
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  • Inactive ingredients

    anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

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  • Questions or comments?

    1-888-287-1915

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  • Principal Display Panel

    Compare to Sudafed PE® Congestion Active Ingredient

    Congestion

    Suphedrine PE

    Phenylephrine HCl Tablets, 10 mg

    Nasal Decongestant

    Non-Drowsy

    Relieves:

    Sinus Pressure

    Congestion

    Maximum Strength

    10 mg

    36 TABLETS

    Actual Size

    Equate Suphedrine PE Image
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  • INGREDIENTS AND APPEARANCE
    EQUATE SUPHEDRINE PE 
    phenylephrine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-131
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    SILICON DIOXIDE  
    TALC  
    TITANIUM DIOXIDE  
    FD&C RED NO. 40  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code L7
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-131-89 18 in 1 CARTON
    1 1 in 1 BLISTER PACK
    2 NDC:49035-131-68 36 in 1 CARTON
    2 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/21/2014
    Labeler - Wal-Mart Stores Inc (051957769)
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