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

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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 and 180 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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 (1800-222-1222).

Directions

FOR 60mg
adults and children 12 years of age and overtake two 60mg tablets with water evrery 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
FOR 180mg
adults and children 12 years of age and overtake 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

  • safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains: sodium 8.2 mg (for 180mg)
  • each tablet contains: sodium 2.7 mg (for 60mg)
  • this product meets the requirements of USP Dissolution Test 2

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 1-888-588-1418

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA,

Made in USA

HOW SUPPLIED

NDC: 71335-0506-1: 30 Tablets in a BOTTLE

NDC: 71335-0506-2: 15 Tablets in a BOTTLE

NDC: 71335-0506-3: 60 Tablets in a BOTTLE

NDC: 71335-0506-4: 90 Tablets in a BOTTLE

NDC: 71335-0506-5: 5 Tablets in a BOTTLE

NDC: 71335-0506-6: 180 Tablets in a BOTTLE

NDC: 71335-0506-7: 100 Tablets in a BOTTLE

Fexofenadine Hcl 180mg Tablet

Label
FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0506(NDC:69230-202)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 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
ShapeCAPSULESize17mm
FlavorImprint Code SG;202
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0506-130 in 1 BOTTLE; Type 0: Not a Combination Product03/23/201801/31/2022
2NDC:71335-0506-215 in 1 BOTTLE; Type 0: Not a Combination Product10/30/201801/31/2022
3NDC:71335-0506-360 in 1 BOTTLE; Type 0: Not a Combination Product10/30/201801/31/2022
4NDC:71335-0506-490 in 1 BOTTLE; Type 0: Not a Combination Product02/19/202001/31/2022
5NDC:71335-0506-55 in 1 BOTTLE; Type 0: Not a Combination Product02/19/202001/31/2022
6NDC:71335-0506-6180 in 1 BOTTLE; Type 0: Not a Combination Product02/19/202001/31/2022
7NDC:71335-0506-7100 in 1 BOTTLE; Type 0: Not a Combination Product03/07/201801/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450709/16/201501/31/2022
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0506) , RELABEL(71335-0506)

Revised: 4/2024
Document Id: 28018c5a-3f2f-4f56-b28a-26b647aa5b8a
Set id: 329b1831-418e-4de0-acf2-4269f03d7947
Version: 7
Effective Time: 20240403
 
Bryant Ranch Prepack