CHILDRENS BENADRYL ALLERGY- diphenhydramine hydrochloride solution

Childrens Benadryl ALLERGY by

Drug Labeling and Warnings

Childrens Benadryl ALLERGY by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. 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

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

• 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)
children under 2 years	do not use
children 2 to 5 years	do not use unless directed by a doctor
children 6 to 11 years	5 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

• each 5 mL contains: sodium 14 mg
• store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
• do not use if bottle wrap, or foil inner seal imprinted "SAFETY SEAL®" 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: 50580-534-04

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)

INGREDIENTS AND APPEARANCE

CHILDRENS BENADRYL ALLERGY 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-534
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: 50580-534-04	1 in 1 CARTON	07/01/2008
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC: 50580-534-08	1 in 1 CARTON	07/01/2008
2		236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
3	NDC: 50580-534-16	2 in 1 PACKAGE	01/28/2009
3		1 in 1 CARTON
3		236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/01/2008

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)