FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet, film coated
Major Pharmaceuticals

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Major Pharmaceuticals Fexofenadine Hydrochloride Tablets, 60 mg Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 60 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 (1-800-222-1222).

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

•: do not use if carton is opened or printed foil under cap is broken or missing
•: store between 20°-25°C (68°-77°F)
•: protect from excessive moisture
•: this product meets the requirements of USP Dissolution Test 3

Inactive ingredients

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

Questions or comments?

1-800-616-2471

Package/Label Principal Display Panel

Compare to the active ingredient in Allegra® Allergy

NON-DROWSY

Fexofenadine Hydrochloride Tablets

60 mg

Antihistamine

12 HR

INDOOR/OUTDOOR ALLERGY RELIEF

-Sneezing

-Runny Nose

-Itchy, Watery Eyes

Itchy Nose or Throat

Allergy

Actual Size

100 Tablets

425-5c-fexofenadine-hydrochloride-tablets

FEXOFENADINE HYDROCHLORIDE
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6979
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (Peach)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	93;7252
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6979-40	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/08/2011	09/30/2021
2	NDC:0904-6979-60	1 in 1 CARTON	10/17/2019	07/31/2022
2		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076447	08/08/2011	07/31/2022

Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2023

Document Id: ef588c95-99aa-4a03-941c-e3297720cbbc

Set id: f0ddec5b-27f1-42ec-9276-284d1d2b0181

Version: 6

Effective Time: 20231129

Major Pharmaceuticals