CHILDRENS ALLEGRA ALLERGY- fexofenadine hydrochloride suspension

Childrens Allegra Allergy by

Drug Labeling and Warnings

Childrens Allegra Allergy by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

(in each 5 mL)

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 10 mL every 12 hours; do not take more than 20 mL in 24 hours
• children 2 to under 12 years of age: take 5 mL every 12 hours; do not take more than 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: mL = milliliters

Other information

• each 5 mL 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

PRINCIPAL DISPLAY PANEL

NDC: 41167-4244-4
Children’s
Allegra®
ALLERGY
fexofenadine HCI
oral suspension
12 HR
30 mg/5 ml antihistamine

INGREDIENTS AND APPEARANCE

CHILDRENS ALLEGRA ALLERGY 
fexofenadine hydrochloride suspension

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

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

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-4244-4	1 in 1 CARTON	03/03/2011
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41167-4244-7	3 in 1 CELLO PACK	03/03/2011
2		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 41167-4244-1	1 in 1 CARTON	03/03/2011
3		240 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Chattem, Inc. (003336013)