SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

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  • SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]
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NDC 50580-545-24, 50580-545-48, 50580-545-72
Set ID d280abe9-6bdf-4e1e-a0cf-95fd0451c999
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 PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 30 mg

  • Purpose

    Nasal decongestant

  • Uses

    • temporarily relieves sinus congestion and pressure
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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 dose

    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 2 tablets every 4 to 6 hours
    • do not take more than 8 tablets in 24 hours
    children ages 6 to 11 years
    • take 1 tablet every 4 to 6 hours
    • do not take more than 4 tablets in 24 hours
    children under 6 yearsdo not use this product in children under 6 years of age
  • Other information

    • store between 20 - 25°C (68 - 77°F)
    • do not use if carton is opened or if blister unit is broken
    • see side panel for lot number and expiration date
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, shellac, sodium starch glycolate, talc, titanium dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    SINUS

    NDC 50580-545-24

    SUDAFED®
    CONGESTION

    Pseudoephedrine HCl, Nasal Decongestant

    SINUS PRESSURE
    + CONGESTION

    MAXIMUM
    STRENGTH

    24 TABLETS
    30 mg EACH

    ‡Actual Pill Size

    NON-DROWSY

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    SUDAFED 
    pseudoephedrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-545
    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
    carnauba wax (UNII: R12CBM0EIZ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    D&C yellow NO. 10 (UNII: 35SW5USQ3G)  
    aluminum oxide (UNII: LMI26O6933)  
    FD&C red NO. 40 (UNII: WZB9127XOA)  
    FD&C yellow NO. 6 (UNII: H77VEI93A8)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    polyvinyl alcohol, unspecified (UNII: 532B59J990)  
    shellac (UNII: 46N107B71O)  
    sodium starch glycolate type a potato (UNII: 5856J3G2A2)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code SU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-545-243 in 1 CARTON07/13/2015
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50580-545-723 in 1 PACKAGE02/29/2016
    2NDC:50580-545-243 in 1 CARTON
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:50580-545-486 in 1 CARTON07/13/2015
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/01/2011
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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