Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hcl 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 January 17, 2020

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  • Drug FactsActive ingredient

    Active ingredient

    (in each 5 mL teaspoonful)

    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 relives 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 childrren
    • sedatives and tranquilizers may increase drowsiness
  • Directions

    • if needed, take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
     Age (yr) Dose (mL or tsp)
     Children under 4 years do not use
     Children 4 to under 6 years do not use unless directed by a doctor
     Children 6 to under 12 years 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

  • Marcs Childrens Allergy Relief Product Label

    NDC 68998-505-24

    Compare to the active ingredient in children's Benadryl® allergy liquid*

    Marcs

    Children's

    Allergy

    Relief

    Antihistamine

    Diphenhydramine HCL

    Oral Solution

    Relieves:

    Sneezing, Runny Nose,

    Itchy Watery Eyes,

    Itchy Throat

    Alcohol-Free

    CHERRY FLVOR

    4 FL OZ (118 mL)

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

    * This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of "Children's Benadryl Allergy Liquid."

    Distributed By:

    Marc Glassman, Inc.

    West 130th Street

    Cleveland, OH 44130

    BX-044

    Internal Label - LR-075  Lot:     Exp:

    AptaMarcs Allergy

    AptaMarcs Allergy1

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-505
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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:68998-505-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/02/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/02/2014
    Labeler - Marc Glassman, Inc. (094487477)
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