Label: SUDO-TAB PE- phenylephrine hcl 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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 15, 2023

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

  • 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

  • OTHER SAFETY INFORMATION

    Other information

    ■ tablets enclosed in a sealed packet

    ■ do not use if packet is torn, cut or open

    ■ store at 59° to 86°F (15°-30°C)

    ■ avoid excessive heat and humidity

  • INACTIVE INGREDIENT

    Inactive Ingredients: croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, silicon dioxide, titanium dioxide. May contain propylene glycol.

  • 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-DOSE10/03/2005
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0126-7125 in 1 BOX, UNIT-DOSE10/03/2005
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0126-8250 in 1 BOX, UNIT-DOSE10/03/2005
    32 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/03/2005
    Labeler - HART Health (069560969)