HEALTHY ACCENTS ALLERGY - diphenhydramine hydrochloride liquid
DZA Brands LLC

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.

----------

Active ingredient (in each 5 mL teaspoonful)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

with any other product containing diphenhydramine, even one used on skin
to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

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

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.

Directions

if needed, take every 4-6 hours
do not take more than 6 doses in 24 hours

children under 4 years of age	do not use
children 4 to under 6 years of age	do not use unless directed by a doctor
children 6 to under 12 years of age	1 to 2 teaspoonfuls (12.5 mg to 25 mg)
adults and children 12 years of age and over	2 to 4 teaspoonfuls (25 mg to 50 mg)

Other information

each teaspoonful contains: sodium 15 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

Questions or comments?

1-866-322-2439

Principal Display Panel

children’s

allergy

diphenhydramine HCl

oral solution

antihistamine

for relief of:

sneezing, runny nose

itchy throat

itchy, watery eyes

Compare to Children’s Benadryl® Allergy Liquid active ingredient

cherry flavor

Allergy Carton Image 1

Allergy Carton Image 2

HEALTHY ACCENTS ALLERGY
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55316-379
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
POLOXAMER 407
WATER
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE
SORBITOL

Product Characteristics
Color	RED (Bluish-Red)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:55316-379-26	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		118 mL in 1 BOTTLE	This package is contained within the CARTON (55316-379-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2008

Labeler - DZA Brands LLC (090322194)

Revised: 11/2011 DZA Brands LLC