Label: SUDOGEST- pseudoephedrine hydrochloride tablet

  • 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 March 6, 2012

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  • DRUG FACTS

     

  • Active Ingredient (in each tablet)

    Pseudoephedrine HCl 30 mg

  • PURPOSE

    Nasal decongestant

  • USES

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis
    • temporarily relieves sinus congestion and pressure
  • 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 contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • diabetes
    • thyroid disease
    • heart disease
    • high blood pressure
    • trouble urinating due to enlargement of the prostate gland

     

    When using this product

    • do not exceed recommended dose

     

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • symptoms do not improve within 7 days or occur with fever

    If pregrant or breast-feeding,

    ask a health professional before use.

  • DOSAGE & ADMINISTRATION

  • Keep out of the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away

  • Directions

    • take every 4 to 6 hours
    • do not exceed 4 doses in 24 hours

    adults and children 12 years & over 2 tablets 
    children 6 to under 12 years 1 tablet 
    children under 6 years ask a doctor 
  • OTHER INFORMATION

    • store at controlled room temperature 15˚-30˚C (59˚-86˚F)
    • see end flap for expiration date and lot number
  • INACTIVE INGREDIENTS

    cellulose, croscarmellose sodium, dicalcium phosphate, FD&C red #40, FD&C yellow #6, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

  • PRINCIPAL DISPLAY PANEL

    Sudogest 30mg (Nasal Decongestant)

  • INGREDIENTS AND APPEARANCE
    SUDOGEST 
    pseudoephedrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-806(NDC:0904-5053)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride30 mg
    Inactive Ingredients
    Ingredient NameStrength
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Polydextrose (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Triacetin (UNII: XHX3C3X673)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44112
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-806-1212 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/1994
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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