FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet
Major Pharmaceuticals

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Major Pharmaceuticals

Active ingredient (in each tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

•: runny nose
•: itchy, watery eyes
•: sneezing
•: 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 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

Other information

•: store at 20° to 25°C (68° to 77°F)
•: protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

Questions or comments?

Call: 1-800-616-2471

Product Label

**Compare to the active ingredient in Allegra® Allergy 24 hour

ORIGINAL PRESCRIPTION STRENGTH

FEXOFENADINE HYDROCHLORIDE Tablets 180 mg/ antihistamine

ALLERGY RELIEF 24 HOUR

NON-DROWSY

RELIEF OF:

sneezing

runny nose

itchy, watery eyes

itchy nose or throat

180 mg EACH

**This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour

SAFETY SEALED: DO NOT USE IF CARTON IS OPEN OR IF INNER SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING OR TORN. (For Bottle configuration only)

DO NOT USE IF CARTON IS OPEN OR IF INDIVIDUAL BLISTER UNIT IS TORN OR OPEN ( For Blister configuration only)

FEXOFENADINE HYDROCHLORIDE
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6311
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE ((Peach))	Score	no score
Shape	CAPSULE	Size	7mm
Flavor		Imprint Code	W987
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6311-18	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/04/2012	07/25/2016
2	NDC:0904-6311-46	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/04/2012	03/19/2017
3	NDC:0904-6311-48	15 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/04/2012	11/24/2016
4	NDC:0904-6311-52	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/04/2012	11/24/2016
5	NDC:0904-6311-89	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/04/2012	11/24/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079112	09/04/2012	03/19/2017

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
Major Pharmaceuticals		191427277	REPACK(0904-6311)

Revised: 7/2018

Document Id: b47462c0-d8be-46d4-8c4a-632591cda0e1

Set id: 88c955ac-e7e0-4df8-a033-4896195575f1

Version: 2

Effective Time: 20180724

Major Pharmaceuticals