CHILDRENS ALLEGRA ALLERGY- fexofenadine hydrochloride suspension
Chattem, Inc.

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Childrens Allegra Allergy Oral Suspension

Drug Facts

Active ingredient

(in each 5 mL teaspoonful)

Fexofenadine HCI 30 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, water eyes
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

Note: teaspoonful = tsp

Other information

each 5 mL teaspoon contains: sodium 18 mg
safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
store between 20º and 25ºC (68º and 77ºF)

Inactive ingredients

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

Questions or comments?

call toll-free 1-800-633-1610 or www.allegra.com

The makers of Allegra® do not make
store brand products.
The trade dress of this Allegra® package is subject to trademark protection.
Dist. By: Chattem, Inc. (part of the sanofi-aventis Group),
Chattanooga, TN 37409-0219 ©2010
Origin Canada 50094566

PRINCIPAL DISPLAY PANEL

NDC 41167-4244-4
Children’s
Allegra®
Allergy
fexofenadine HCL oral
suspension 30 mg/5 ml

antihistamine

NDC 41167-4244-4
Children’s
Allegra®
Allergy
fexofenadine HCL oral
suspension 30 mg/5 ml
antihistamine

PRINCIPAL DISPLAY PANEL

NDC 41167-4244-4
Children’s
Allegra®
Allergy
fexofenadine HCL oral
suspension 30 mg/5 ml
antihistamine

CHILDRENS ALLEGRA ALLERGY
fexofenadine hydrochloride suspension

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:41167-4244
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE)	FEXOFENADINE HYDROCHLORIDE	6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYLPARABEN
EDETATE DISODIUM
POLOXAMER 407
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SUCROSE
TITANIUM DIOXIDE
XANTHAN GUM
XYLITOL

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:41167-4244-1	1 in 1 CARTON
1		240 mL in 1 BOTTLE
2	NDC:41167-4244-4	1 in 1 CARTON
2		120 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA201373	03/03/2011

Labeler - Chattem, Inc. (003336013)

Name	Address	ID/FEI	Business Operations
Establishment
Sanofi-Aventis U.S. LLC		783243835	ANALYSIS(41167-4244), LABEL(41167-4244), MANUFACTURE(41167-4244), PACK(41167-4244)

Revised: 2/2014

Document Id: 05e79be5-efac-4f0d-af1f-1224d1acb99b

Set id: e2bd23c7-dfba-463a-adbe-2183970da740

Version: 11

Effective Time: 20140212

Chattem, Inc.