Childrens Allegra Allergy-ODT

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]

CHILDRENS ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, orally disintegrating 
Chattem, Inc.

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Childrens Allegra Allergy-ODT

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

• each tablet contains: sodium 5 mg
  
• phenylketonurics: contains phenylalanine 5.3 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

Inactive ingredients

aspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 41167-4233-3
NON-DROWSY
Children’s
Allegra®
Allergy
fexofenadine HCl orally disintegrating
tablets 30 mg/antihistamine
Indoor and Outdoor Allergies
Orange Cream flavored
12 Orally Disintegrating Tablets

CHILDRENS ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-4233
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL (round with beveled edges)	Size	13mm
Flavor	ORANGE (Orange Cream)	Imprint Code	e;311;AV
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-4233-3	2 in 1 CARTON	03/03/2011	01/02/2018
1		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	03/03/2011	01/02/2018

Labeler - Chattem, Inc. (003336013)

Revised: 2/2019

Document Id: 30c89a70-49ab-46b2-b111-5bdea37848a4

34390-5

Set id: f5eb861f-0ebd-4d37-a62a-5fecde4c65bd

Version: 13

Effective Time: 20190222

 

Chattem, Inc.