Label: EQUATE NASAL DECONGESTANT PE MAXIMUM STRENGTH- phenylephrine hydrochloride tablet

  • NDC Code(s): 49035-094-68, 49035-094-89
  • 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 07/09

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

  • Active ingredient (in each tablet)

    Phenylephrine hydrochloride 10 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 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

    carnauba wax, dibasic calcium phosphate, 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?  

    1-800-996-5358

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  • Principal Display Panel

    Non-Drowsy

    See New Dosing Directions

    Maximum Strength

    Nasal Decongestant PE

    Phenylephrine HCl Tablets – Nasal Decongestant

    Does not contain Pseudophedrine

    Nasal & Sinus Congestion

    Sinus Pressure

    Actual Size

    1 Tablet/Dose

    Nasal Decongestant PE Carton

    Nasal Decongestant PE Carton

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  • INGREDIENTS AND APPEARANCE
    EQUATE NASAL DECONGESTANT PE  MAXIMUM STRENGTH
    phenylephrine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-094
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    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:49035-094-68 2 in 1 CARTON
    1 18 in 1 BLISTER PACK
    2 NDC:49035-094-89 1 in 1 CARTON
    2 18 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 02/07/2005
    Labeler - Wal-Mart Stores Inc (051957769)
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