CHILDRENS ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, orally disintegrating

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 tablet)

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

• place 1 tablet on tongue; tablet disintegrates, with or without water

• adults and children 12 years of age and over: take 2 tablets every 12 hours on an empty stomach; do not take more than 4 tablets in 24 hours
• children 6 to under 12 years of age: take 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
• children under 6 years of age: do not use
• adults 65 years of age and older: ask a doctor
• consumers with kidney disease: ask a doctor

Other information

• phenylketonurics: contains phenylalanine 3.8 mg per tablet
  
• safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  
• store between 20º and 25ºC (68º and 77ºF)
  
• use tablet immediately after opening individual blister
  
• contains lactose

Inactive ingredients

aspartame, crospovidone, flavors, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, silicon dioxide

Questions or comments?

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

Dist. By: Chattem, Inc, a Sanofi Company,

Chattanooga, TN 37409-0219 ©2015             0100036-01

PRINCIPAL DISPLAY PANEL

NDC: 41167-4232-1
NON-DROWSY
Children’s
Allegra® 
Allergy
fexofenadine HCl orally disintegrating
tablet 30 mg/antihistamine
Indoor and Outdoor Allergies
Orange Cream flavor
12 Orally Disintegrating Tablets

PRINCIPAL DISPLAY PANEL

NDC: 41167-4232-6
NON-DROWSY
Children’s
Allegra® 
Allergy
fexofenadine HCl orally disintegrating
tablet 30 mg/antihistamine
Indoor and Outdoor Allergies
Orange Cream flavor
24 Orally Disintegrating Tablets

INGREDIENTS AND APPEARANCE

CHILDRENS ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-4232
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

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor	ORANGE (Orange Cream)	Imprint Code	e;311;AV
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-4232-1	2 in 1 CARTON	01/02/2014
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-4232-6	4 in 1 CARTON	01/02/2014
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021909	01/02/2014

Labeler - Chattem, Inc. (003336013)