Childrens Allergy Fexofenadine Hydrochloride Oral Suspension

Drug Facts

Active ingredient

(in each 5 mL = 1 teaspoonful)
Fexofenadine HCl, USP 30 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

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product:

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

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

shake well before using
use only with enclosed dosing cup

adults and children 12 years of age and over	take 2 teaspoonfuls (10 mL) every 12 hours; do not take more than 4 teaspoonfuls (20 mL) in 24 hours
children 2 to under 12 years of age	take 1 teaspoonful (5 mL) every 12 hours; do not take more than 2 teaspoonfuls (10 mL) in 24 hours
children under 2 years of age	ask a doctor
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

Other information

• each 5 mL (1 teaspoonful) contains: sodium 18 mg
• safety sealed: do not use if carton, unprinted foil inner seal, or neckband printed with “SEALED FOR YOUR PROTECTION” is opened, torn or missing.
•store between 20° to 25°C (68° to 77°F).
•before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucrose, titanium dioxide, xanthan gum, xylitol

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL

Compare to Children’s Allegra® active ingredient*

NDC 37808-527-94
HEB®

Ages 2 years and older

Allergy Relief
Children’s

Fexofenadine Hydrochloride Oral Suspension
30 mg/ 5mL
Antihistamine

Indoor and Outdoor Allergies
● 12 Hour Relief of:
Runny nose
Sneezing
Itchy, Watery Eyes
Itchy Nose or Throat
● Non- Drowsy

Use only with enclosed dosing cup. Wash & let air dry after each use.

Dye- Free and Alcohol Free
Berry Flavor

4 fl oz (118 mL)

CHILDRENS ALLERGY RELIEF
fexofenadine hydrochloride suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-527
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	30 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYLPARABEN (UNII: 3QPI1U3FV8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
Does not contain	ALCOHOL (UNII: 3K9958V90M)	0 in 5 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37808-527-94	1 in 1 CARTON	07/01/2015	03/31/2018
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203330	07/01/2015	03/31/2018

Labeler - HEB (007924756)

Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2017

Document Id: c56d9c94-854c-4086-a62f-20499f092df3

Set id: 499f9d13-1a01-4941-bb72-04ef362c73ca

Version: 3

Effective Time: 20171214

HEB