FDA Label for Foster And Thrive Childrens Allergy Relief

View Indications, Usage & Precautions

ACTIVE INGREDIENT(S)
PURPOSE
USE(S)
WARNINGS
DO NOT USE
ASK A DOCTOR BEFORE USE IF THE CHILD HAS
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
WHEN USING THIS PRODUCT
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS
PRINCIPAL DISPLAY PANEL

Foster And Thrive Childrens Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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(S)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Use(S)

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

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

glaucoma
a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If The Child Is

taking sedatives or tranquilizers

When Using This Product

sedatives and tranquilizers may increase drowsiness
marked drowsiness may occur
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
measure only with dosing cup provided
do not use dosing cup with other products
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

Other Information

each 5 mL contains: sodium 5 mg
dosing cup provided
store between 20°-25°C(68°-77°F)

Inactive Ingredients

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

Questions Or Comments

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

Principal Display Panel

NDC 70677-1012-2

COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT*

Foster & Thrive TM

Children's Allergy Relief

Diphenhydramine HCl oral solution,

12.5 mg/5ml

ANTIHISTAMINE

Dye Free

4-6 Hours/Dose

Relief of:

Runny Nose
Itchy Watery Eyes
Sneezing
Itchy Throat or Nose

2+ Ages

CHERRY FLAVOR

DOSING CUP INCLUDED

8FL OZ(236 mL)

549ft8label - 549ft8label

NDC 70677-1012-1

COMPARE TO CHILDREN'S BENADRYL^® ORAL SOLUTION ACTIVE INGREDIENT*

Foster & Thrive ^TM