Label: CHILDRENS BENADRYL ALLERGY PLUS CONGESTION- diphenhydramine hydrochloride and phenylephrine hydrochloride solution

  • NDC Code(s): 50580-341-01
  • 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 February 25, 2021

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

  • 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)