FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated
NuCare Pharmaceuticals, Inc.

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Active ingredient(in each tablet)

Fexofenadine HCl USP, 180 mg

Fexofenadine HCl USP, 60 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper resporatory 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 aluminium or magnesium antacids
do not take with fruit juices (see directions)

Stop use and ask 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

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

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 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 and light

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions or comments?

call 1-855-274-4122

Principal Display Panel

pdp

FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68071-1896(NDC:58602-711)
Route of Administration	ORAL

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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (Peach)	Score	no score
Shape	CAPSULE (Bevel Edge, Biconvex)	Size	17mm
Flavor		Imprint Code	E;44
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68071-1896-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2017
2	NDC:68071-1896-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202039	01/15/2015	12/31/2021

Labeler - NuCare Pharmaceuticals, Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals, Inc.		010632300	repack(68071-1896)

Revised: 7/2024

Document Id: 1d601f20-e95c-69d1-e063-6394a90a0d97

Set id: 4bce3ec1-d120-62ba-e054-00144ff8d46c

Version: 4

Effective Time: 20240716

NuCare Pharmaceuticals, Inc.