SUDOGEST 12 HOUR (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]

SUDOGEST 12 HOUR (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]
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NDC 0904-6754-15
Set ID e829aab0-3ef0-4149-8197-96c5ce0b31d2
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number ANDA075153
  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 120 mg

  • Purpose

    Nasal decongestant

  • Uses

    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    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 drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

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

    When using this product

    do not exceed recommended dosage

    Stop use and ask a doctor if

    nervousness, dizziness, or sleeplessness occur
    symptoms do not improve within 7 days or occur with a fever

    If pregnant or breast-feeding,

    ask a health professional before use.

    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).

  • Directions

    adults and children 12 years and over

    take 1 tablet every 12 hours
    do not take more than 2 tablets in 24 hours

    children under 12 years

    do not use this product in children under 12 years of age

  • Other information

    each tablet contains: calcium 45 mg
    store at 20-25°C (68-77°F) in a dry place
    protect from light
    do not use if blister unit is broken or torn
    see carton end panel for lot number and expiration date
    this product meets the requirements of USP Drug Release Test 3
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    COMPARE TO the active ingredient of SUDAFED® SINUS CONGESTION 12 HOUR CAPLETS

    Sinus

    SudoGest 12 HOUR

    Pseudoephedrine Hydrochloride Extended-Release Tablets, USP 120 mg

    Nasal Decongestant

    Sinus Pressure

    Congestion

    MAXIMUM STRENGTH

    Actual Size

    NON-DROWSY

    10 COATED CAPLETS* (120 mg) EACH)

    *Capsule-Shaped Tablets

    sudogest image
  • INGREDIENTS AND APPEARANCE
    SUDOGEST 12 HOUR 
    pseudoephedrine hcl tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6754
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code L054
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6754-1510 in 1 CARTON02/12/2019
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07515302/12/2019
    Labeler - Major Pharmaceuticals (191427277)

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