FEXOFENADINE HCL- fexofenadine hcl tablet, film coated 
Bryant Ranch Prepack

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®Tablets

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

HOW SUPPLIED

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

Fexofenadine Hcl 60mg Tablet

Label
FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-2165(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:71335-2165-130 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
2NDC:71335-2165-210 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
3NDC:71335-2165-360 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
4NDC:71335-2165-490 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
5NDC:71335-2165-514 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
6NDC:71335-2165-620 in 1 BOTTLE; Type 0: Not a Combination Product08/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450708/26/2021
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-2165) , RELABEL(71335-2165)

Revised: 1/2024
Document Id: a96608c4-5ec4-4d19-8401-f3d0b36282a2
Set id: c23ad304-a5de-454e-a135-4eb143af2381
Version: 102
Effective Time: 20240116
 
Bryant Ranch Prepack