FEXOFENADINE HCL tablet, film coated

fexofenadine hcl by

Drug Labeling and Warnings

fexofenadine hcl by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, ScieGen Pharmaceuticals, Inc.. 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

Package/Label Principal Display Panel

MAJOR ®

NDC: 0904-7192-04

Compare to the
active ingredient in
Allegra ®Allergy *

Non-Drowsy

Fexofenadine Hydrochloride
Tablets, USP

60 mg

Antihistamine

12-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

100 Tablets

Allergy Relief

MAJOR ®

NDC: 0904-7192-60

Compare to the
active ingredient in
Allegra ®Allergy *

Non-Drowsy

Fexofenadine Hydrochloride
Tablets, USP

60 mg

Antihistamine

12-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

100 Tablets

Allergy Relief

MAJOR ®

NDC: 0904-7192-40

Compare to
the active ingredient in
Allegra ®Allergy *

Non-Drowsy

Fexofenadine
Hydrochloride
Tablets, USP

60 mg

Antihistamine

12-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

500 Tablets

Allergy Relief

MAJOR ®

NDC: 0904-7486-02

Compare to the active
ingredient in Allegra ®
Allergy 24 Hour Tablets *

Non-Drowsy

Fexofenadine Hydrochloride
Tablets, USP

180 mg

Antihistamine

24-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

30 Tablets

Allergy Relief

MAJOR ®

NDC: 0904-7486-03

Compare to the active
ingredient in Allegra ®
Allergy 24 Hour Tablets *

Non-Drowsy

Fexofenadine Hydrochloride
Tablets, USP

180 mg

Antihistamine

24-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

30 Tablets

Allergy Relief

MAJOR ®

NDC: 0904-7486-60

Compare to the active
ingredient in Allegra ®
Allergy 24 Hour Tablets *

Non-Drowsy

Fexofenadine Hydrochloride
Tablets, USP

180 mg

Antihistamine

24-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

100 Tablets

Allergy Relief

MAJOR ®

NDC: 0904-7486-40

Compare to the active
ingredient in Allegra ®Allergy
24 Hour Tablets *

Non-Drowsy

Fexofenadine
Hydrochloride
Tablets, USP

180 mg

Antihistamine

24-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

500 Tablets

Allergy Relief

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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: 0904-7192-04	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/20/2024
2	NDC: 0904-7192-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/26/2021
3	NDC: 0904-7192-40	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/26/2021

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

FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7486
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
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	CAPSULE	Size	17mm
Flavor		Imprint Code	SG;202
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7486-02	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/20/2024
2	NDC: 0904-7486-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/20/2024
3	NDC: 0904-7486-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/20/2024
4	NDC: 0904-7486-40	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204507	08/20/2024

Labeler - Major Pharmaceuticals (191427277)

Registrant - ScieGen Pharmaceuticals, Inc. (079391286)

Establishment
Name	Address	ID/FEI	Business Operations
ScieGen Pharmaceuticals, Inc.		079391286	analysis(0904-7192, 0904-7486) , manufacture(0904-7192, 0904-7486) , pack(0904-7192, 0904-7486) , label(0904-7192, 0904-7486)