SUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]

SUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]
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NDC 50332-0126-4, 50332-0126-7, 50332-0126-8
Set ID 6f70ed59-a1f8-4daa-8614-feaf2533687b
Category HUMAN OTC DRUG LABEL
Packager HART Health
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

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

  • PURPOSE

    Purpose: Nasal Decongestant

  • INDICATIONS & USAGE

    Uses: Temporarily relieves nasal congestion and sinus pressure due to

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

    Warnings:

  • 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.

  • 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
  • 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
  • PREGNANCY OR BREAST FEEDING

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

  • 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

  • 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

  • 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

  • PRINCIPAL DISPLAY PANEL

    SudoTabPE.jpg

  • INGREDIENTS AND APPEARANCE
    SUDO-TAB PE 
    phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0126
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 271
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0126-450 in 1 BOX, UNIT-DOSE
    12 in 1 PACKET
    2NDC:50332-0126-7125 in 1 BOX, UNIT-DOSE
    22 in 1 PACKET
    3NDC:50332-0126-8250 in 1 BOX, UNIT-DOSE
    32 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/03/2005
    Labeler - HART Health (069560969)

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