Label: CHILDRENS ALLERGY- diphenhydramine hydrochloride solution

  • 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 20, 2021

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  • Drug Facts

    Active ingredient [in each 5 mL]
    Diphenhydramine HCl, USP 12.5 mg

  • Purpose

    Antihistamine

  • 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
  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin
  • Ask a doctor before use if the child has

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium-restricted diet
  • Ask a doctor or pharmacist before use if you

    are taking sedatives or tranquilizers

  • When using this product

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

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    • mL = milliliter 

    Age (yr)
    		Dose (mL)
    children under 6 years of age
    		ask a doctor
    children 6 years to under 12 years of age
    		5 mL to 10 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 9 mg
    • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

    Questions or comments? 1-855-274-4122

    Distributed ByATLANTIC BIOLOGICALS CORP. 

    20101 N.E 16TH PLACE 

    MIAMI, FL 33179

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

    NDC 17856-0361-01

    Compare to
    Children's Benadryl®
    active ingredient*

    Children's
    ALLERGY
    Antihistamine
    diphenhydramine hydrochloride
    25mg/10 mL oral solution 
    liquid medication

    Relieves:

    • Runny Nose
    • Sneezing
    • Itchy, Watery Eyes
    • Itchy Throat

    Sugar & Alcohol Free
    Dye-FreeBubble Gum Flavored


    image 1

    NDC 17856-0361-02

    Compare to
    Children's Benadryl®
    active ingredient*

    Children's
    ALLERGY

    Antihistamine

    diphenhydramine hydrochloride
    12.5mg/5mL oral solution
    liquid medication

    Relieves:

    Runny Nose
    Sneezing
    Itchy, Watery Eyes
    Itchy Throat
    Sugar & Alcohol Free

    Dye-Free
    Bubble Gum Flavored

    image 2

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0361(NDC:46122-361)
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITE (Colorless) Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0361-172 in 1 BOX, UNIT-DOSE01/20/2021
    110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:17856-0361-272 in 1 BOX, UNIT-DOSE01/20/2021
    25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/20/2016
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-0361) , repack(17856-0361)
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