BENADRYL ALLERGY- diphenhydramine hydrochloride solution

BENADRYL Allergy by

Drug Labeling and Warnings

BENADRYL Allergy by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
• runny nose
• sneezing

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

• find right dose on chart below
• mL = milliliter
• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 doses in 24 hours

• 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 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

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

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

Alcohol Free

Wild Cherry

Flavored Liquid

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

BENADRYL ALLERGY 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-573
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-573-04	1 in 1 CARTON	12/02/2024
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/02/2024

Labeler - Kenvue Brands LLC (118772437)