FDA Label for Childrens Allergy Relief

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH 5 ML TSP)
PURPOSE
USES
DO NOT USE
ASK ADOCTOR BEFORE USE IF YOU HAVE
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
WHEN USING THIS PRODUCT
IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
PDP

Childrens Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Mckesson. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each 5 Ml Tsp)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

Do Not Use

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

Ask Adoctor Before Use If You Have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
marked drowsiness may occur
excitability may occur especially in children
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

take every 4 to 6 hours
do not take more than 6 doses in 24 hours


Age (yr)	Dose (mL or tsp)
children under 2 years	do not use
children under 6 years	ask a doctor
children 6 to under 12 years	1 to 2 tsp (5 mL to 10 mL)
adults and children 12 years and above	2 to 4 tsp (10 mL to 20 mL)

Other Information

each tsp contains: sodium 5 mg
dosing cup provided
store at 68^o - 77^oF

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol

Pdp

Sunmark

Compare to childrens benadyl active ingredient

Children's allergy relief dye-free

antihistamine

Relieves sneezing, runny nose, itchy, watery eyes, itchy throat

Diphenhydramine HCl