Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride liquid

  • 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 October 28, 2019

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  • Active ingredient

    Drug Facts

    Active ingredient  
    (in each 5 mL teaspoon)

    Diphenhydramine HCL 12.5 mg

  • Purpose

    Antihistamine

  • Keep out of reach of children

    Keep out of reach of children.

     In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    •    temporarily relieves these symptoms due to hay fever or other respiratory allergies:
        •    sneezing
        •    itching of the nose or throat
        •    runny nose
        •    itchy watery eyes
    •    temporarily relieves these symptoms due to the common cold:
        •    sneezing
        •    runny nose

  • Warnings

    Do not use
    •    with any other product containing diphenhydramine, even one used on skin
    •    to make a child sleepy

  • Ask a doctor before use if the child has

    •    glaucoma
    •    a breathing problem such as chronic bronchitis

  • Ask a doctor or pharmacist before use if the child is

     taking sedatives or tranquilizers

  • When using this product

    •    marked drowsiness may occur
    •    excitability may occur, especially in children
    •    sedatives and tranquilizers may increase drowsiness

  • Directions

    •    if needed, take every 4-6 hours
    •    do not take more than 6 doses in 24 hours

    Children under 4 years of age:                                    do not use
    Children 4 to under 6 years of age:                             do not use unless directed by a doctor
    Children 6 to under 12 years of age:                           1 to 2 teaspoonfuls
                                                                                   (12.5 mg to 25 mg)

  • Other information

    •    Keep carton for full directions for use
    •    each teaspoonful contains: sodium 10 mg
    •    store at 20-25 ° C (68-77 ° F)
    •    dosage cup provided

  • Inactive ingredients

    Citric acid, D and C Red # 33, FD and C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

  • Questions or comments?

    Call weekdays from 9:30 AM to 4:30 PM EST at

    1-877-798-5944

  • Product Label

    SOUND BODY™
    COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL® ALLERGY LIQUID*

    Relieves:  Sneezing, Runny Nose, Itchy Watery Eyes, Itchy Throat

    Children’s
    Allergy
    Relief

    Diphenhydramine HCL Oral Solution Antihistamine

    Alcohol-free

    Cherry Flavor

    4 FL OZ (118 mL)

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Manufactured by:
    AptaPharma Inc.
    1533 Union Ave.
    Pennsauken, NJ 08110

    V#5002632  ITEM#301

    BX-034

    LOT:
    EXP:

    AptaPharma ChildAllergyRelief Label

    AptaPharma ChildAllergyRelief1 Label

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-301
    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
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-301-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/21/2013
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-301)
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