FEXOFENADINE HYDROCHLORIDE

Sun Pharmaceutical Industries Limited

Fexofenadine Hydrochloride Tablets, USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• FEXOFENADINE HYDROCHLORIDE Uses
• Warnings
• Do not use
• Ask a doctor before use if you have
• When using this product
• Stop use and ask doctor if
• If pregnant or breast-feeding
• Keep out of reach of children.
• Directions
• FEXOFENADINE HYDROCHLORIDE Other information
• Inactive ingredients
• Questions?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Purpose

FEXOFENADINE HYDROCHLORIDE Uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

• trouble swallowing
• dizziness or loss of consciousness
• swelling of tongue
• swelling in or around mouth
• trouble speaking
• drooling
• wheezing or problems breathing

Do not use

• to prevent hives from any known cause such as:
  • foods
  • insect stings
  • medicines
  • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• kidney disease. Your doctor should determine if you need a different dose.
• hives that are an unusual color, look bruised or blistered
• hives that do not itch

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 doctor if

• an allergic reaction to this product occurs. Seek medical help right away.
• symptoms do not improve after 3 days of treatment
• the hives have lasted more than 6 weeks

If pregnant or breast-feeding

Keep out of reach of children.

Directions

FEXOFENADINE HYDROCHLORIDE Other information

• safety sealed; do not use if inner safety seal is open or torn
• store between 20° to 25°C (68° to 77°F)
• protect from excessive moisture

Inactive ingredients

Questions?

Call toll free 1-800-818-4555 weekdays.

Principal Display Panel

For 30 mg Hives Relief:

NDC 62756-542-16
Children's
Fexofenadine Hydrochloride Tablets, USP
30 mg
HIVES
(12 Hour)
Antihistamine
Relief of ITCHING Due to Hives
100 Tablets 30 mg each
SUN PHARMA












For 60 mg Hives Relief:

NDC 62756-543-16
Fexofenadine Hydrochloride Tablets, USP
60 mg
HIVES
(12 Hour)
Antihistamine
Relief of ITCHING Due to Hives
100 Tablets 60 mg each
SUN PHARMA



For 180 mg Hives Relief:

NDC 62756-545-16
Fexofenadine Hydrochloride Tablets, USP
180 mg
HIVES
(24 Hour)
Antihistamine
Relief of ITCHING Due to Hives
100 Tablets 180 mg each
SUN PHARMA

FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED Product Information Product Type Human otc drug label Item Code (Source) NDC:62756-542 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE FEXOFENADINE 30 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline STARCH, CORN CROSPOVIDONE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) titanium dioxide polyethylene glycol 400 ferric oxide red FERRIC OXIDE YELLOW Product Characteristics Color Size Imprint Code Shape PINK 6 mm 542 ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-542-15 30 in 1 BOTTLE 2 NDC:62756-542-16 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091567 2012-02-06

FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED Product Information Product Type Human otc drug label Item Code (Source) NDC:62756-543 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE FEXOFENADINE 60 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline STARCH, CORN CROSPOVIDONE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) titanium dioxide polyethylene glycol 400 ferric oxide red FERRIC OXIDE YELLOW Product Characteristics Color Size Imprint Code Shape PINK 12 mm 543 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-543-15 30 in 1 BOTTLE 2 NDC:62756-543-16 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091567 2012-02-06

FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED Product Information Product Type Human otc drug label Item Code (Source) NDC:62756-545 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE FEXOFENADINE 180 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline STARCH, CORN CROSPOVIDONE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) titanium dioxide polyethylene glycol 400 ferric oxide red FERRIC OXIDE YELLOW Product Characteristics Color Size Imprint Code Shape PINK 17 mm 545 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-545-15 30 in 1 BOTTLE 2 NDC:62756-545-16 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091567 2012-02-06