Fexofenadine HCL by Akron Pharma Inc. FEXOFENADINE HCL tablet

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 over	take one 60 mg 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

180 mg

adults and children 12 years of age and over	take one 180 mg 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 the bottle is torn or missing.
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
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 30 CT

NDC: 71399-8042-3

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
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL
fexofenadine hcl tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 71399-8042-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/09/2024
2	NDC: 71399-8042-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204507	09/09/2020

Labeler - Akron Pharma Inc. (067878881)

Name	Address	ID/FEI	Business Operations
Establishment
ScieGen Pharmaceuticals LLC		079391286	manufacture(71399-8042)

Fexofenadine HCL by