Label: SUDAFED PE CONGESTION- phenylephrine hydrochloride tablet

  • NDC Code(s): 50580-546-50, 50580-546-51
  • 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 August 13, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Phenylephrine HCl 10 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 1 tablet every 4 hours
    • do not take more than 6 tablets in 24 hours
    children under 12 yearsask a doctor
  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if carton or blister unit is opened or broken
  • Inactive ingredients

    carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, 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 50580-546-50

    SUDAFEDPE®

    CONGESTION

    Phenylephrine HCl Tablets
    Nasal Decongestant

    SINUS + NASAL
    CONGESTION

    SINUS PRESSURE

    18 TABLETS
    10 mg EACH

    MAXIMUM
    STRENGTH

    FORMERLY NAMED
    SUDAFED PE® Nasal Decongestant

    1 Pill/Dose
    ‡ Actual Pill Size

    NON-DROWSY

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    SUDAFED PE CONGESTION 
    phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-546
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg
    Inactive Ingredients
    Ingredient NameStrength
    carnauba wax (UNII: R12CBM0EIZ)  
    D&C yellow no. 10 aluminum lake (UNII: CQ3XH3DET6)  
    aluminum oxide (UNII: LMI26O6933)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    polyvinyl alcohol, unspecified (UNII: 532B59J990)  
    powdered cellulose (UNII: SMD1X3XO9M)  
    sodium starch glycolate Type A potato (UNII: 5856J3G2A2)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code WL;80;PE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-546-501 in 1 CARTON07/13/2015
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50580-546-512 in 1 CARTON07/13/2015
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/13/2015
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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