FEXOFENADINE HYDROCHLORIDE- fexofenadine tablet, film coated
Golden State Medical Supply, Inc.

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Drug Facts

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

PRINCIPAL DISPLAY PANEL - 60 mg

NDC 60429-388-01

Non-Drowsy

Fexofenadine HCl
Tablets, USP

60 mg

Allergy

12 HR

Antihistamine
Indoor/Outdoor Allergy Relief

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

RM-AR0781D2 60 Tablets

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

Fexofenadine HCl Tablets, USP 60 mg Bottle Label - Front Layer

PRINCIPAL DISPLAY PANEL - 180 mg

NDC 60429-389-01

Non-Drowsy

Fexofenadine HCl
Tablets, USP

180 mg

Allergy

24 HR

Antihistamine
Indoor/Outdoor Allergy Relief

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

RM-AR0782H2 30 Tablets

Directions
adults and children 12 years of age and over	take one 180 mg 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

Fexofenadine HCl Tablets, USP 180 mg Bottle Label - Front Layer

FEXOFENADINE HYDROCHLORIDE
fexofenadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60429-388(NDC:0378-0781)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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	ROUND	Size	8mm
Flavor		Imprint Code	M;753
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60429-388-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/20/2014	04/11/2018
2	NDC:60429-388-05	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/20/2014	04/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077081	03/20/2014	04/11/2018

FEXOFENADINE HYDROCHLORIDE
fexofenadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60429-389(NDC:0378-0782)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60429-389-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/20/2014	04/11/2018
2	NDC:60429-389-05	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/20/2014	04/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077081	03/20/2014	04/11/2018

Labeler - Golden State Medical Supply, Inc. (603184490)

Name	Address	ID/FEI	Business Operations
Establishment
Golden State Medical Supply, Inc.		603184490	repack(60429-388, 60429-389) , relabel(60429-388, 60429-389)

Revised: 4/2018

Document Id: 6a280651-1808-c85c-e053-2a91aa0aeadf

Set id: 5ba85881-dba1-4932-a8dc-c1afdb980e98

Version: 3

Effective Time: 20180418

Golden State Medical Supply, Inc.