FEXOFENADINE HCL- fexofenadine hcl tablet 
Akron Pharma Inc.

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Fexofenadine Hydrochloride Tablets USP, 180 mg

ACTIVE INGREDIENT(S), in each tablet

Fexofenadine hydrochloride USP, 180 mg

PURPOSE

Antihistamine

USE(S)

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.

DIRECTIONS

60 mg

adults and children 12 years of age and overtake one 60 mg tablet with water every 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

180 mg

adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet 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

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.

HOW SUPPLIED SECTION

Fexofenadine Hydrochloride Tablets, USP 180 mg 100 CT

NDC: 71399-8042-1

QUESTIONS OR COMMENTS

Call weekdays 8.30 AM to 4.30 PM EST Please Call 1(877) 225-6999

Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
Manufactured in U.S.A

180

FEXOFENADINE HCL 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8042
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)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code SG;202
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-8042-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450709/09/2020
Labeler - Akron Pharma Inc. (067878881)

Revised: 2/2023
Document Id: bd010bd9-531a-49dd-b4f1-9754af7b577e
Set id: 08023b99-0634-4ac9-afd6-4f2d2e0d2c8a
Version: 3
Effective Time: 20230226
 
Akron Pharma Inc.