SUDAFED 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

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  • SUDAFED 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

SUDAFED 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]
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NDC 50580-342-01, 50580-342-02
Set ID 51bb5e49-6ae1-4321-865d-d7cff1e0097c
Category HUMAN OTC DRUG LABEL
Packager Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number ANDA075153
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 yearsdo 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 torn or broken
    • 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?

    call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    SINUS
    NDC 50580-342-02

    SUDAFED®
    12 HOUR

    Pseudoephedrine HCl Extended-Release Tablets, 120 mg
    Long-Acting Nasal Decongestant

    SINUS PRESSURE
    + CONGESTION

    Pseudoephedrine
    HCl

    20 COATED CAPLETS*
    120 mg EACH

    MAXIMUM
    STRENGTH

    NON-DROWSY

    *CAPSULE-SHAPED TABLETS
    ‡ Actual Size

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    SUDAFED 12 HOUR 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-342
    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)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code SU12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-342-011 in 1 CARTON09/01/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50580-342-022 in 1 CARTON09/01/2017
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07515309/01/2017
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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