ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, coated

Allegra Allergy by

Drug Labeling and Warnings

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

Allegra Allergy® Gelcaps – 24 HOUR

Drug Facts

Active ingredient

(in each tablet)

Fexofenadine HCI 180 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

• adults and children 12 years of age and over: take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
• children under 12 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

• 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) 
  
• protect from excessive moisture

Inactive ingredients

croscarmellose sodium, D&C red 28, D&C red 33, FD&C blue 1, gelatin, hydroxypropylcellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, PEG-135, pharmaceutical ink, pregelatinized starch, titanium dioxide

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., a Sanofi Company, Chattanooga, TN 37409-0219 ©2014

PRINCIPAL DISPLAY PANEL

NDC: 41167-4122-0
Allegra® Allergy
Fexofenadine HCI tablets
180 mg/antihistamine
24 HR
8 Gelcaps 

PRINCIPAL DISPLAY PANEL

NDC: 41167-4122-0
Allegra® Allergy
Fexofenadine HCI tablets
180 mg/antihistamine
24 HR
8 Gelcaps 
PROFESSIONAL SAMPLE
NOT FOR RETAIL SALE

INGREDIENTS AND APPEARANCE

ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-4122
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PURPLE (White band in the middle)	Score	no score
Shape	OVAL (Caplet)	Size	20mm
Flavor		Imprint Code	AG;AG
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-4122-0	1 in 1 CARTON	12/17/2014
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-4122-2	1 in 1 CARTON	12/17/2014
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 41167-4122-5	1 in 1 CARTON	12/17/2014
3		24 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 41167-4122-6	1 in 1 CARTON	12/17/2014
4		32 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 41167-4122-9	2 in 1 CARTON	12/17/2014	06/23/2019
5	NDC: 41167-4122-7	40 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	NDA020872	12/17/2014

Labeler - Chattem, Inc. (003336013)