Label: SUDO-TAB PE- phenylephrine hydrochloride tablet 

  • NDC Code(s): 50332-0126-4, 50332-0126-7, 50332-0126-8
  • Packager: HART Health
  • 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 11/12

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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet): Phenylephrine HCl 5mg

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  • PURPOSE

    Purpose: Nasal Decongestant

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  • INDICATIONS & USAGE

    Uses: Temporarily relieves nasal congestion and sinus pressure due to

    • the common cold
    • hay fever
    • upper respiratory allergies
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  • WARNINGS

    Warnings:

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  • DO NOT USE

    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), for 2 weeks after stopping the MAOI drug, or if you do not know if your prescription drug contains and MAOI.

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  • ASK DOCTOR

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
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  • STOP USE

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • symptoms do not improve within 7 days
    • symptoms are accompanied by a fever
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

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  • KEEP OUT OF REACH OF CHILDREN

    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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  • DOSAGE & ADMINISTRATION

    Directions: do not take more than directed

    Adults and children 12 years of age and over:

    • take 2 tablets every 4 hours while symptoms persist
    • do not take more than 12 tablets in 24 hours unless directed by a doctor

    Children under 12 years of age: ask a doctor

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Croscarmellose Sodium, FD&C Red #40, FD&C Yellow #6, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Silicon Dioxide, Titanium Dioxide

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  • INGREDIENTS AND APPEARANCE
    SUDO-TAB PE 
    phenylephrine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50332-0126
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    LACTOSE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    PROPYLENE GLYCOL  
    SILICON DIOXIDE  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color red Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code 271
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0126-4 50 in 1 BOX, UNIT-DOSE
    1 2 in 1 PACKET
    2 NDC:50332-0126-7 125 in 1 BOX, UNIT-DOSE
    2 2 in 1 PACKET
    3 NDC:50332-0126-8 250 in 1 BOX, UNIT-DOSE
    3 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/03/2005
    Labeler - HART Health (069560969)
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