BENADRYL ALLERGY- diphenhydramine hydrochloride solution 
Kenvue Brands LLC

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BENADRYL Allergy Oral Solution

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 user has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if the user is taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding, ask a health professional before use.

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)
adults and children
12 years and over
10 mL to 20 mL (2x10 mL;
Note: dosing cup needs to
be filled to 10 mL line twice
for the 20 mL dose)
children 6 to 11 years5 mL to 10 mL
children 2 to 5 yearsdo not use unless directed
by a doctor
children under 2 yearsdo not use

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

Other information

■ each 5 mL contains: sodium 14 mg
■ store between 20-25ºC (68-77ºF). Protect from light. Store in outer carton until contents used.
do not use if carton is opened
■ do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing

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 50580-573-04

NEW DOSING FOR ADULTS

Benadryl ®

ALLERGY

LIQUID

Diphenhydramine HCl/antihistamine
12.5 mg/5 mL oral solution

Same as Children’s Benadryl® Allergy Liquid

Alcohol Free

Wild Cherry

Flavored Liquid

4 fl oz (118 mL)

benadryl-1

BENADRYL ALLERGY 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-573
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:50580-573-041 in 1 CARTON12/02/2024
1118 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 DrugM01212/02/2024
Labeler - Kenvue Brands LLC (118772437)

Revised: 1/2025
Document Id: 2cc68544-e514-f895-e063-6394a90aa577
Set id: 224ba2a3-1a93-29c8-e063-6394a90a9bef
Version: 3
Effective Time: 20250130
 
Kenvue Brands LLC