Label: CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2023

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  • ACTIVE INGREDIENT

    Drug Facts       


    Active ingredient                   
    (in each 5 mL teaspoon)

    Diphenhydramine HCL 12.5 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    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

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

  • ASK DOCTOR

    Ask a doctor before use if the child has
    ■ glaucoma
    ■ abreathing problem such as chronic bronchitis

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the
    child is taking sedatives or tranquilizers

  • WHEN USING

    When using this product

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

  • 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.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    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 INGREDIENT

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

  • QUESTIONS

    Questions or comments? Call weekdays
    from 9:30 AM to 4:30 PM EST at 1-877-798-5944.

  • Product Label

    AP SAFE                                NDC 72681-505-24

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

    Children's
    Allergy
    Relief

    DIPHENHYDRAMINE HCl
    Liquid
    Antihistamine

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

    • Alcohol-Free

    4 FL OZ (118 mL)             Cherry Flavor

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

          2
    1013430
       3/20

    *This product is not manufactured or
    distributed by McNeil PPC, Inc., distributor
    of Benadryl® Allergy liquid.

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

    AP-BX-03

    Carton

    505-24 Box

    Bottle

    505-24 Btl

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-505
    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
    ColorpinkScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-505-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/30/2020
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-505)
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