Allegra-D 12 Hour Allergy and Congestion

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

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

adults and children 12 years of age and overtake 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 agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4310
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE, COLLOIDAL 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
STARCH, PREGELATINIZED CORN 
STEARIC ACID 
Product Characteristics
ColorWHITE (white and tan) Score no score
ShapeOVALSize19mm
FlavorImprint Code 06;012D
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:41167-4310-22 BLISTER PACK (2 BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
15 TABLET, FILM COATED, EXTENDED RELEASE (5 TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (41167-4310-2)
2NDC:41167-4310-44 BLISTER PACK (4 BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
25 TABLET, FILM COATED, EXTENDED RELEASE (5 TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (41167-4310-4)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02078603/03/2011

Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Chattem Plant 1003336013ANALYSIS, LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
Chattem Plant 3832973031LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
Sanofi-Aventis U.S. LLC783243835ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 07/2011 Chattem, Inc.