ALLEGRA D 12 HOUR ALLERGY AND CONGESTION - fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Chattem, Inc.

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Drug Facts

Active ingredients

(in each tablet)

Fexofenadine HCI 60 mg

Purpose

Antihistamine

Active ingredients

(in each tablet)

Pseudoephedrine HCI 120 mg

Purpose

Nasal decongestant

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
▪    runny nose
▪    sneezing
▪    nasal congestion
▪    itchy, watery eyes
▪    itching of the nose or throat
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have difficulty swallowing

Ask a doctor before use if you have

heart disease
thyroid disease
glaucoma
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
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)
the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve within 7 days or are accompanied by a fever
you get nervous, dizzy, or sleepless

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

do not divide, crush, chew or dissolve the tablet; swallow tablet whole

adults and children 12 years of age and over	take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets 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)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, stearic acid

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. (part of the sanofi-aventis Group),

PRINCIPAL DISPLAY PANEL

NDC 41167-4310-2
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Allergra-D®
12 Hour Allergy
& Congestion
fexofenadine HCI 60 mg/antihistamine
pseudoephedrine HCI 120 mg/nasal decongestant
Extended Release Tablets
10 Tablets 12 HOUR

PRINCIPAL DISPLAY PANEL
NDC 41167-4310-2
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Allergra-D®
12 Hour Allergy
& Congestion
fexofenadine HCI 60 mg/antihistamine
pseudoephedrine HCI 120 mg/nasal decongestant
Extended Release Tablets
10 Tablets 12 HOUR

ALLEGRA D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-4310
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE)	FEXOFENADINE HYDROCHLORIDE	60 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX
SILICON DIOXIDE, COLLOIDAL
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
STARCH, PREGELATINIZED CORN
STEARIC ACID

Product Characteristics
Color	WHITE (white and tan)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	06;012D
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41167-4310-2	2 BLISTER PACK (2 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		5 TABLET, FILM COATED, EXTENDED RELEASE (5 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (41167-4310-2)
2	NDC:41167-4310-4	4 BLISTER PACK (4 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
2		5 TABLET, FILM COATED, EXTENDED RELEASE (5 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (41167-4310-4)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020786	03/03/2011

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Operations
Chattem Plant 1		003336013	ANALYSIS, LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Operations
Chattem Plant 3		832973031	LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Operations
Sanofi-Aventis U.S. LLC		783243835	ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 07/2011 Chattem, Inc.