FEXOFENADINE HCL tablet, film coated

fexofenadine hcl by

Drug Labeling and Warnings

fexofenadine hcl by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLERGY Active 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 (1-800-222-1222).

Directions

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 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg)
• this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

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

QUESTIONS

Questions or comments?

Call toll-free 1-888-588-1418
Monday-Friday 9AM-7PM EST

Distributed by: MAJOR ®PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

HOW SUPPLIED

Fexofenadine Hydrochloride Tablets 60 mg

• NDC: 71335-2165-1: 30 Tablets in a BOTTLE
• NDC: 71335-2165-2: 10 Tablets in a BOTTLE
• NDC: 71335-2165-3: 60 Tablets in a BOTTLE
• NDC: 71335-2165-4: 90 Tablets in a BOTTLE
• NDC: 71335-2165-5: 14 Tablets in a BOTTLE
• NDC: 71335-2165-6: 20 Tablets in a BOTTLE
• NDC: 71335-2165-7: 12 Tablets in a BOTTLE

store between 20° and 25°C (68° and 77°F). protect from excessive moisture.

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Tablets 60 mg

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-2165(NDC:0904-7192)
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: 71335-2165-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2024
2	NDC: 71335-2165-2	10 in 1 BOTTLE; Type 0: Not a Combination Product	08/25/2022
3	NDC: 71335-2165-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2024
4	NDC: 71335-2165-4	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2024
5	NDC: 71335-2165-5	14 in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2024
6	NDC: 71335-2165-6	20 in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2024
7	NDC: 71335-2165-7	12 in 1 BOTTLE; Type 0: Not a Combination Product	11/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204507	08/26/2021

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-2165) , RELABEL(71335-2165)