Allegra Allergy

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Croscarmellose Sodium D&c Red No. 28 D&c Red No. 33 Fd&c Blue No. 1 Gelatin Hydroxypropyl Cellulose (1600000 Wamw) Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 6000 Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: AG;AG Shape: oval Color: purple Size: 20 mm Score: 1

Marketing Status

NDA Active Since 2014-12-17 Until 2019-06-23

Medication Information

Purpose

Antihistamine

Description

Allegra Allergy® Gelcaps – 24 HO UR Drug Facts

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

Section 42229-5

Allegra Allergy® Gelcaps – 24 HO UR

Drug Facts

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Active Ingredient

(in each tablet)

Fexofenadine HCI 180 mg

Other Information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened
store between 20^º and 25^ºC (68^º and 77^ºF)
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 tablet

180 mg/antihistamine

24 HR

8 GELCAPS

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.

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)

Structured Label Content

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

Section 42229-5 (42229-5)

Allegra Allergy® Gelcaps – 24 HO UR

Drug Facts

Purpose

Antihistamine

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Active Ingredient (Active ingredient)

(in each tablet)

Fexofenadine HCI 180 mg

Other Information (Other information)

safety sealed: do not use if carton is opened or if individual blister units are torn or opened
store between 20^º and 25^ºC (68^º and 77^ºF)
protect from excessive moisture

Inactive Ingredients (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? (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 (PRINCIPAL DISPLAY PANEL)

NDC 41167-4122-0

Allegra®

ALLERGY

fexofenadine HCI tablet

180 mg/antihistamine

24 HR

8 GELCAPS

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Allegra Allergy® Gelcaps – 24 HO UR Drug Facts", "Purpose": "Antihistamine", "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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "Active ingredient": "(in each tablet) Fexofenadine HCI 180 mg", "Other information": "safety sealed: do not use if carton is opened or if individual blister units are torn or opened store between 20 º and 25 º C (68 º and 77 º F) 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 tablet 180 mg/antihistamine 24 HR 8 GELCAPS ", "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.", "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)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information