FEXOFENADINE HCL tablet, film coated

fexofenadine hcl by

Drug Labeling and Warnings

fexofenadine hcl by is a Otc medication manufactured, distributed, or labeled by ScieGen Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

    HIVESActive ingredient (in each film-coated tablet)

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

INDICATIONS & USAGE

Uses

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

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

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

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health profession immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

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 a 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,

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 (for 60mg)

• adults and children 12 years of age and over:

  take one 60mg tablet with water every 12 hours; 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

Directions (for 180mg)

• adults and children 12 years of age and over:

  take one 180mg tablet with water once a day; 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

• store between 20° and 25°C (68° and 77°F)
• protect from excessive moisture
• each tablet contains: sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
• this product meets the requirements of USP Dissolution Test 2
• Tamper Evident: Do not use if imprinted inner safety seal is torn or missing

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.

Questions or comments?

Call toll-free 1-855-724-3436

Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA

                             ALLERGYActive ingredient (in each film-coated tablet)

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

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

Warnings

Do not use

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.

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.

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 (for 60mg)

• adults and children 12 years of age and over:

  take one 60mg tablet with water every 12 hours; 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

Directions (for 180mg)

• adults and children 12 years of age and over:

  take one 180mg tablet with water once a day; 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

• store between 20° and 25°C (68° and 77°F)
• protect from excessive moisture
• each tablet contains: sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
• this product meets the requirements of USP Dissolution Test 2
• Tamper Evident: Do not use if imprinted inner safety seal is torn or missing

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.

Questions or comments?

Call toll-free 1-855-724-3436

PRINCIPAL DISPLAY PANEL

Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50228-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SG;201
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50228-201-01	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2014
2	NDC: 50228-201-02	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2014
3	NDC: 50228-201-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2014
4	NDC: 50228-201-04	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204507	12/26/2014

FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50228-202
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	SG;202
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50228-202-01	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2014
2	NDC: 50228-202-02	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2014
3	NDC: 50228-202-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2014
4	NDC: 50228-202-04	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204507	12/26/2014

Labeler - ScieGen Pharmaceuticals, Inc. (079391286)

Registrant - ScieGen Pharmaceuticals, Inc. (079391286)

Establishment
Name	Address	ID/FEI	Business Operations
ScieGen Pharmaceuticals, Inc.		079391286	ANALYSIS(50228-201, 50228-202) , MANUFACTURE(50228-201, 50228-202) , PACK(50228-201, 50228-202) , LABEL(50228-201, 50228-202)