FDA Label for Allegra-d Allergy And Congestion

Active Ingredients

(in each extended-release tablet)

Fexofenadine HCl 180 mg

(in each extended-release tablet) 

Pseudoephedrine HCl 240 mg

Purpose

Antihistamine

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

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 24 hours on an empty stomach; do not take more than 1 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

• each tablet contains: sodium 33 mg
  
• safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  
• store between 20° and 25°C (68° and 77°F)

Inactive Ingredients

acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, glycerol triacetate, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, povidone, sodium chloride, talc, titanium dioxide, water

Questions Or Comments?

call toll-free 1-800-633-1610 or www.allegra.com

Principal Display Panel

NDC 41167-4320-7
NON-DROWSY
Allegra-D^®
ALLERGY & CONGESTION
fexofenadine HCl 180 mg/antihistamine
pseudoephedrine HCl 240 mg/nasal decongestant
Extended Release Tablets
15 Tablets

PRINCIPAL DISPLAY PANELNDC 41167-4320-7NON-DROWSYAllegra-D®ALLERGY & CONGESTIONfexofenadine HCl 180 mg/antihistaminepseudoephedrine HCl 240 mg/nasal decongestantExtended Release Tablets15 Tablets - allegra d allergy and congestion 24 hr 01