CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid 
QUALITY CHOICE (Chain Drug Marketing Association)

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Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

Warnings

Do not use

  • to make a child sleep 
  • 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
  • a sodium-restricted diet

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 (1-800-222-1222) right away.

Directions

 Age (yr) Dose (mL)
 children 6 to 11 years5 mL to 10 mL
 children 2 to 5 years do not use unless directed by a doctor
 children under 2 yearsdo not use

Other information

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

call 1-248-449-9300 Monday-Friday 9AM-5PM EST 

Principal Display Panel

*Compare to the active ingredient in Children's Benadryl® Allergy

Children's Allergy

Oral Solution

Diphenhydramine HCl 12.5 mg

Antihistamine

For Ages 6 to 11 Years

Alcohol Free

Bubblegum Flavor

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare distributor Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Package Label

Diphenhydramine HCI 12.5 mg

QUALITY CHOICE Children's Allergy

CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-370
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)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-370-041 in 1 BOX05/30/2014
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/30/2014
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 4/2024
Document Id: dae6da5b-20e4-44c3-a68a-f4b1360aad14
Set id: 9bddedbb-40a2-47d3-be35-7b6fce4f755d
Version: 7
Effective Time: 20240422
 
QUALITY CHOICE (Chain Drug Marketing Association)