CHILDRENS BENADRYL ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

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  • CHILDRENS BENADRYL ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

CHILDRENS BENADRYL ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]
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NDC 50580-341-01
Set ID b8b75904-3806-4258-89c1-d6ff486ed41c
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

    Active ingredients (in each 5 mL)Purposes
    Diphenhydramine HCl 12.5 mgAntihistamine
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
      • nasal congestion
      • stuffy nose
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing
      • nasal congestion
      • stuffy nose
    • temporarily relieves sinus congestion and pressure
  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin
    • 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
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dose
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    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

    • find right dose on chart below
    • mL = milliliter
    • take every 4 hours
    • do not take more than 6 doses in 24 hours
    Age (yr)Dose (mL)
    children under 4 yearsdo not use
    children 4 to 5 yearsdo not use unless directed by a doctor
    children 6 to 11 years5 mL
    adults and children 12 years and over10 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 10 mg
    • store between 20-25°C (68-77°F)
    • 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 blue no. 1, FD&C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • Questions or comments?

    call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-341-01

    Children's
    Benadryl®

    ALLERGY PLUS
    CONGESTION

    Diphenhydramine HCl / antihistamine
    Phenylephrine HCl / nasal decongestant
    oral solution

    4 Hours/Dose

    RELIEF OF:

    ✓
    Runny Nose
    ✓
    Sneezing
    ✓
    Itchy, Watery Eyes
    ✓
    Itchy Throat or Nose
    ✓
    Sinus Congestion
    ✓
    Stuffy Nose

    Alcohol Free
    Sugar Free

    ALLERGY + CONGESTION RELIEF

    Grape!
    Flavored Liquid

    4 fl oz (118 mL)

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CHILDRENS BENADRYL ALLERGY PLUS CONGESTION 
    diphenhydramine hydrochloride and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-341
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) Diphenhydramine hydrochloride12.5 mg  in 5 mL
    Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    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
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-341-011 in 1 CARTON09/30/2014
    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 FINALpart34109/30/2014
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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