Label: CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid

  • NDC Code(s): 53942-505-24
  • Packager: DeMoulas Market Basket
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • Drug FactsActive 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 Ask a doctor or pharmacist before use

    Ask a doctor before use if the child has

    •    glaucoma
    •    a breathing problem such as chronic bronchitis

    Ask a doctor or pharmacist before 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 # 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

    “MORE FOR YOUR DOLLAR”
    MARKET BASKET ®

    *COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY LIQUID

    Children’s Allergy

    Diphenhydramine HCL Oral Solution Antihistamine

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

    Alcohol-free

    Cherry Flavor

    4 FL OZ (118 mL)

    Lot:
    Exp:

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

    *This product is not manufactured or distributed by McNeil-PPC, Inc. distributer of Benadryl® Allergy Liquid.

    DISTRIBUTED BY
    DEMOULAS SUPERMARKETS INC.
    875 EAST STREET
    TEWKSBURY MA 01876

    BX-014 Rev 01

    AptaPharmMB ChildAllergy

    AptaPharmMB ChildAllergy 1

    res

    AptaPharmMB ChildAllergy

    AptaPharmMB ChildAllergy 1

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-505
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53942-505-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/11/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00909/11/2012
    Labeler - DeMoulas Market Basket (007869647)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(53942-505)
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