Label: ALLERGY RELIEF CHILDRENS- diphenhydramine hcl solution

  • NDC Code(s): 51316-180-36
  • Packager: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 24, 2025

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient (in each 5 mL)

    Diphenhydramine HCl 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 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
    • sedatives and tranquilizers may increase drowsiness
    • 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.

  • Directions

    • do not take more than directed
    • do not take more than 6 doses in 24 hours
    • mL = milliliter
    • only use the dose cup provided
    • find right dose on chart below
    • take every 4 to 6 hours, or as directed by a doctor
    Age (yr)Dose (mL)
    children under 2 yearsdo not use
    children 2 to 5 yearsdo not use unless directed by a doctor
    children 6 to 11 years5 mL to 10 mL
  • Other information

    • each 5 mL contains: sodium 4 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    NDC 51316-180-36

    ♥︎CVS™

    Ages
    6–11
    years 

    Bubble Gum Flavor

    Children’s
    ALLERGY
    RELIEF
    Diphenhydramine HCl
    12.5 mg / 5 mL

    Oral Solution ι Antihistamine

    Compare to Children’s Benadryl®
    Dye-Free Allergy active ingredient*

    Relief of: Sneezing,
    Runny nose, Itchy, watery eyes,
    Itchy throat or nose

    DYE
    FREE

    Free of:
    Parabens & Sugar
    No Added Alcohol

    4–6
    HOURS

    4 FL OZ (118 mL)

    dosing cup
    included

    TAMPER EVIDENT: DO NOT USE IF PRINTED
    NECK WRAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by
    Kenvue Inc., owner of the registered trademark
    Children’s Benadryl® Dye-Free Allergy.

    50844     ORG072401836

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2025 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    V-39965

    ♥︎ 100% money back
    guaranteed.
    CVS.com/returnpolicy

    package contains one bottle
    actual size

    CVS 44-018

    CVS 44-018

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  CHILDRENS
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-180
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-180-361 in 1 CARTON04/22/2025
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/22/2025
    Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(51316-180) , pack(51316-180)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!