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Allegra D 12 Hour Allergy and Congestion

Dosage form: tablet, film coated, extended release
Ingredients: FEXOFENADINE HYDROCHLORIDE 60mg, PSEUDOEPHEDRINE HYDROCHLORIDE 120mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-931

Allegra-D 12 Hour Allergy and Congestion

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 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
  • 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

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:21695-931(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) Scoreno score
ShapeOVALSize19mm
FlavorImprint Code06;012D
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-931-204 BLISTER PACK (BLISTER PACK) in 1 CARTON
15 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02078603/03/2011
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 07/2011
 
Rebel Distributors Corp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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