FDA Label for Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

Other

Drug Facts

DISTRIBUTED BY
PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

Otc - Purpose

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)

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

• do not use if carton is opened or if individual blister units are torn or opened
• store between 68° to 77°F (20° to 25°C)
• USP dissolution test is pending.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

Principal Display Panel - 30 Tablet Blister Pack Carton

NDC 56062-999-30

NON-DROWSY
ORIGINAL PRESCRIPTION STRENGTH

allergyreliefD

FEXOFENADINE HCl 60 mg/ANTIHISTAMINE
PSEUDOEPHEDRINE HCl 120 mg/NASAL DECONGESTANT
EXTENDED-RELEASE TABLETS, USP

ALLERGY & CONGESTION • INDOOR & OUTDOOR ALLERGIES

12-hour relief of:

• Nasal & sinus congestion due to colds or allergies
• Sneezing; runny nose; itchy, watery eyes & itchy nose or throat due to allergies

ACTUAL SIZE

30
EXTENDED-RELEASE
TABLETS

*Compare to the active ingredients
in Allegra-D^®

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

Principal Display Panel - 30 Tablet Blister Pack Carton - fexofenadine 01