FEXOFENADINE HCL- fexofenadine hcl tablet, film coated 
Safrel Pharmaceuticals, LLC.

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FEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg

Allergy



ALLERGY

Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP, 60mg

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 (1800-222-1222).

Directions

FOR 60mg

adults and children 12 years of age and over

take two 60mg tablets with water evrery 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 1-844-384-3723

Distributed by:
Safrel Pharmaceuticals, LLC

Bridgewater, NJ 08807

www.safrel.com

Fexofenadine 60 mg

Fexo 60 mg

FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-090
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
ShapeOVAL (Modified Oval) Size12mm
FlavorImprint Code SG;201
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71309-090-10100 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450712/08/2022
Labeler - Safrel Pharmaceuticals, LLC. (080566287)

Revised: 7/2023
Document Id: 01c94d0a-30a6-baf4-e063-6394a90a90e3
Set id: 01c94471-3509-4240-e063-6294a90a203b
Version: 1
Effective Time: 20230731
 
Safrel Pharmaceuticals, LLC.