FEXOFENADINE HCL- fexofenadine hcl tablet, film coated 
Major Pharmaceuticals

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ALLERGY

Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP 60 mg

Purpose

Antihistamine

Uses

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

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 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

Other information

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.

Questions or comments?

Call toll-free  1-800-616-2471

Distributed by:

MAJOR ® PHARMACEUTICALS

Livonia, MI 48152

Package/Label Principal Display Panel

MAJOR ®

NDC 0904-7192-60

Compare to the active ingredient in Allegra ® Allergy

Non-Drowsy

Fexofenadine Hydrochloride Tablets USP

60 mg

Antihistamine

12 HR

Indoor/Outdoor Allergy Relief

• Sneezing • Runny Nose

• Itchy, Watery Eyes • Itchy Nose or Throat

100 Tablets             Allergy

ScieGen Pharmaceuticals, Inc.

MAJOR ®

NDC 0904-7192-40

Compare to the active ingredient in Allegra ® Allergy

Non-Drowsy

Fexofenadine Hydrochloride Tablets USP

60 mg

Antihistamine

12 HR

Indoor/Outdoor Allergy Relief

• Sneezing • Runny Nose

• Itchy, Watery Eyes • Itchy Nose or Throat

500 Tablets             Allergy

ScieGen Pharmaceuticals, Inc.
FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7192
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeOVALSize12mm
FlavorImprint Code SG;201
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7192-60100 in 1 BOTTLE; Type 0: Not a Combination Product08/26/2021
2NDC:0904-7192-40500 in 1 BOTTLE; Type 0: Not a Combination Product08/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450708/26/2021
Labeler - Major Pharmaceuticals (191427277)
Registrant - ScieGen Pharmaceuticals, Inc. (079391286)
Establishment
NameAddressID/FEIBusiness Operations
ScieGen Pharmaceuticals, Inc.079391286analysis(0904-7192) , manufacture(0904-7192) , pack(0904-7192) , label(0904-7192)

Revised: 9/2021
Document Id: cb925905-0058-85f6-e053-2995a90a3552
Set id: 107f398c-f296-4190-8234-82556a039e65
Version: 1
Effective Time: 20210909
 
Major Pharmaceuticals