CHILDRENS BENADRYL ALLERGY- diphenhydramine hydrochloride solution 
Johnson & Johnson Consumer Inc.

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Children's Benadryl ® ALLERGY

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

  • 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

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

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

Inactive ingredients

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

call 1-877-717-2824 or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-534-04

Children's

Benadryl ®

ALLERGY

Diphenhydramine HCl/antihistamine

12.5 mg/5 mL oral solution

4-6 Hours/Dose

RELIEF OF:

Alcohol Free

Cherry!

Flavored

4 fl oz (118 mL)

benadryl-1

CHILDRENS BENADRYL ALLERGY 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-534
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)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-534-041 in 1 CARTON07/01/2008
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:50580-534-081 in 1 CARTON07/01/2008
2236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
3NDC:50580-534-162 in 1 PACKAGE01/28/200912/28/2022
31 in 1 CARTON
3236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
4NDC:50580-534-182 in 1 PACKAGE04/12/2021
41 in 1 CARTON
4236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/01/2008
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 1/2024
Document Id: 0f871ecd-6a33-580b-e063-6394a90a9be9
Set id: fc9181b9-c92d-493e-8d7c-4a4239c6c092
Version: 11
Effective Time: 20240122
 
Johnson & Johnson Consumer Inc.