Allegra D 12 Hour Allergy and Congestion

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-800-633-1610

Websitewww.allegra.comwww.allegra.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Fexofenadine HCI 60 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Pseudoephedrine HCI 120 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  
• store between 20^º and 25^ºC (68^º and 77^ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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• Allegra D 12 Hour Allergy and Congestion
• fexofenadine hydrochloride and pseudoephedrine hydrochloride
• FEXOFENADINE HYDROCHLORIDE
• FEXOFENADINE
• PSEUDOEPHEDRINE HYDROCHLORIDE
• PSEUDOEPHEDRINE
• CARNAUBA WAX
• SILICON DIOXIDE, COLLOIDAL
• CROSCARMELLOSE SODIUM
• HYPROMELLOSES
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• POLYETHYLENE GLYCOL
• STARCH, PREGELATINIZED CORN
• STEARIC ACID

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Ingredients#

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