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

Allegra-D Allergy and Congestion by

Drug Labeling and Warnings

Allegra-D Allergy and Congestion 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 ingredients

(in each tablet)

Fexofenadine HCl 60 mg

Purpose

Antihistamine

Active ingredients

(in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  ▪ runny nose
  ▪ sneezing
  ▪ itchy, watery eyes
  ▪ itching of the nose or throat
  
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  
• 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 yearsof age and over: take 1 tablet with a glass of water; every 12 hours on an empty stomach; do; not take more than 2 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)

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

PRINCIPAL DISPLAY PANEL

NDC: 41167-4310-6
Allegra-D®
Allergy &
Congestion 12HR
fexofenadine HCl 60 mg/antihistamine
pseudoephedrine HCl 120 mg/nasal decongestant
Extended Release Tablets
30 Tablets

INGREDIENTS AND APPEARANCE

ALLEGRA-D 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

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	Marketing Start Date	Marketing End Date
1	NDC: 41167-4310-2	1 in 1 CARTON	03/03/2011
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-4310-4	2 in 1 CARTON	03/03/2011
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-4310-6	3 in 1 CARTON	03/03/2011
3		10 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	NDA020786	03/03/2011

Labeler - Chattem, Inc. (003336013)