Label: SUDAFED- pseudoephedrine hydrochloride tablet, coated

  • NDC Code(s): 50580-545-24, 50580-545-48, 50580-545-72
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • 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 December 6, 2019

If you are a consumer or patient please visit this version.

  • 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)