FEXOFENADINE HYDROCHLORIDE- fexofenadine tablet, film coated

Fexofenadine Hydrochloride by

Drug Labeling and Warnings

Fexofenadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC, Golden State Medical Supply, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Fexofenadine hydrochloride USP, 60 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

• adults and children 12 years of age and over:

  take one 60 mg 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

Other information

• Tamper Evident: do not use if foil seal under cap is missing, open or broken
• store between 20° to 25°C (68° to 77°F)
• protect from excessive moisture

Inactive ingredients

Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

Questions or comments?

Call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Marketed/ Packaged by: GSMS, Inc., Camarillo, CA 93012 USA

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

• Count: 180 mg
• 30: 43353-760-30
• 60: 43353-760-53
• 90: XXXXX-XXX-60
• 120: XXXXX-XXX-70
• 180: XXXXX-XXX-80
• 240: XXXXX-XXX-90
• 270: XXXXX-XXX-92

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20171201JH

PRINCIPAL DISPLAY PANEL - 180mg

NDC: 43353-760 - Fexofenadine HCl 180mg - Rx Only

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43353-760(NDC: 60429-389)
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
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL (caplet-shaped)	Size	18mm
Flavor		Imprint Code	M;755
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43353-760-53	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/09/2014
2	NDC: 43353-760-60	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077081	03/20/2014

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Golden State Medical Supply, Inc.		603184490	REPACK(43353-760)