CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

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CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]
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NDC 50580-784-04
Set ID 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d
Category HUMAN OTC DRUG LABEL
Packager Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Phenylephrine HCl 2.5 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 in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • a sodium-restricted diet

    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

    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

    • find right dose on chart below
    • mL = milliliter
    • repeat dose every 4 hours
    • do not use more than 6 times in 24 hours
    Age (yr)Dose (mL)
    under 4 yearsdo not use
    4 to 5 years5 mL
    6 to 11 years10 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • each 5 mL contains: sodium 14 mg
    • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.
    • do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-784-04

    children's
    SUDAFED®
    PE

    non-drowsy

    NASAL
    DECONGESTANT

    Phenylephrine HCl Oral Solution
    Nasal Decongestant

    RELIEF OF

    ✓
    Stuffy Nose
    ✓
    Sinus Pressure

    Berry
    FLAVOR LIQUID
    ALCOHOL &
    SUGAR FREE

    4 fl oz (118 mL) 2.5 mg per 5 mL

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    CHILDRENS SUDAFED PE   NASAL DECONGESTANT
    phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-784
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C red No. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium citrate, unspecified form (UNII: 1Q73Q2JULR)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorRASPBERRY (BERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-784-041 in 1 CARTON10/01/2008
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/01/2008
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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