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

Allegra D 12 Hour Allergy and Congestion by

Drug Labeling and Warnings

Allegra D 12 Hour Allergy and Congestion by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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),

Chattanooga, TN 37409-0219 ©2010       50094535

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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: 21695-931(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, COLLOIDAL (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
STARCH, PREGELATINIZED 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: 21695-931-20	4 in 1 CARTON
1		5 in 1 BLISTER PACK

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

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK