Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl, USP 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 (1-800-222-1222).

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

Other information

safety sealed: do not use if carton is opened or if inner safety seal is torn or missing
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive ingredients

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

Questions or comments?

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

CVS Health®

Compare to the active ingredient in
Allegra® Allergy 24 Hour Tablets*

NDC 51316-800-70

Allergy Relief

FEXOFENADINE HYDROCHLORIDE
TABLETS, USP 180 mg
Antihistamine

INDOOR/OUTDOOR
ALLERGY RELIEF

24
HOUR

Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat

Non-Drowsy

Package Contains
One Bottle

70 TABLETS

Actual Size

PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51316-800
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	545
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51316-800-90	1 in 1 CARTON	09/20/2022
1		90 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51316-800-70	1 in 1 CARTON	09/20/2022
2		70 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:51316-800-45	1 in 1 CARTON	09/20/2022
3		45 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:51316-800-30	1 in 1 CARTON	09/20/2022
4		30 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:51316-800-15	1 in 1 CARTON	09/20/2022
5		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:51316-800-08	1 in 1 CARTON	09/20/2022
6		180 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091567	09/20/2022

Labeler - CVS PHARMACY, INC (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Pharmaceutical Industries Limited		650445203	MANUFACTURE(51316-800)

Fexofenadine Hydrochloride Tablets, USP 180 mg