CHILDRENS BENADRYL ALLERGY- diphenhydramine hydrochloride solution 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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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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:

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat or Nose

Alcohol Free

Cherry!
Flavored

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL
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 PACKAGE01/28/2009
31 in 1 CARTON
3236 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 FINALpart34107/01/2008
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 11/2020
Document Id: 9b764699-f6f8-47b2-8add-d5e0053cb07f
Set id: fc9181b9-c92d-493e-8d7c-4a4239c6c092
Version: 5
Effective Time: 20201119
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division