Label: SUDOGEST- pseudoephedrine hcl tablet, coated

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 18, 2020

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  • Active Ingredient

    In each tablet Pseudoephedrine HCl 30 mg

  • Purpose

      Nasal Decongestant

  • 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

  • Indications and Usage

    INDICATIONS AND USAGE:

    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

    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.

  • Dosage and Administration

    DOSAGE AND ADMINISTRATION:

    Directions – take every 4-6 hours -Do not take more than 4 does in 24 hours

    Adults and children 12 years and over – 2 tablets

    Children 6 to under 12 years – 1 tablet

    Children under 6 years – do not use

  • Inactive Ingredients

    INACTIVE INGREDIENTS:  acacia, calcium sulfate, carnauba Wax. colloidal silicon dioxide, corn starch, D-C red no. 27, D-C yellow no.10, FD-C red no.40, FD-C yellow  no 6, iron oxide black, iron oxide red, iron oxide yellow (iron oxide ochre) Kaolin, microcrystalline cellulose, polyethylene glycol (PEG) 400, , pregelatinized starch, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

  • Questions or Comments?

     1-800-616-2471

  • Storage

    Store at 25ºC (77ºF). Excursions permitted between 15º-30ºC (59º-86ºF).

    Protect from light.

  • HOW SUPPLIED

    Product: 50090-1955

    NDC: 50090-1955-0 28 TABLET, COATED in a BOTTLE

  • PSEUDOEPHEDRINE HCL

    Label Image
  • INGREDIENTS AND APPEARANCE
    SUDOGEST 
    pseudoephedrine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1955(NDC:0904-6338)
    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
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code TCL016
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-1955-028 in 1 BOTTLE; Type 0: Not a Combination Product08/17/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/17/2014
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-1955) , REPACK(50090-1955)