ALLERGY CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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.

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Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • 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 the 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 years 5 mL to 10 mL
 children 2 to 5 years do not use unless directed by a doctor
 children under 2 years do not use

Other information

Inactive ingredients

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

Questions or comments?

 Call toll free 1-866-4-REXALL

Principal Display Panel

Children's

Allergy

DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg

ORAL SOLUTION ANTIHISTAMINE

Relief of

ALCOHOL FREE

Bubble Gum FLAVOR

FOR AGES 6-11

Dosing Cup included

FL OZ (mL)

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

PACKAGED FOR DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072 USA

Visit us at: Rexall.com

Product Label

Diphenhydramine HCI 12.5 mg

REXALL Children's Allergy

ALLERGY  CHILDRENS ALLERGY
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-091
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)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCROSE (UNII: C151H8M554)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-091-041 in 1 BOX06/30/201501/31/2025
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 finalpart34106/30/201501/31/2025
Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 10/2022
Document Id: a6c1e37f-b80a-4ba9-ad70-4e50d9901093
Set id: a8437409-7fa5-4ebb-956e-ef838c8264d9
Version: 6
Effective Time: 20221024
 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)