FEXOFENADINE HYDROCHLORIDE tablet

Fexofenadine Hydrochloride by

Drug Labeling and Warnings

Fexofenadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by CVS Health Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or otherupper 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 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

Other information

• (Bottle only)-safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
• (Blister only)- Safety sealed: Do not use if seal is broken or if individual blister unit is torn or open
• store between 20° and 25°C (68° and 77°F)
• protect from excessive moisture
• this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide.

Questions?

Call 1-888-375-3784

Carton label

Carton Label: 30 count

CVS Health

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

Indoor & Outdoor Alllergies

Original Prescription Strength

Allergy Relief

FEXOFENADINE HYDROCHLORIDE
TABLETS USP, 180 MG

24 Hour Relief of:

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy nose or throat

Non-Drowsy 24 HOUR

Actual Bottle Size on Bottom Panel

Package Contains One Bottle

40 TABLETS 180 mg EACH

Bottle Label

Bottle Label: 40 count

CVS Health

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

Indoor & Outdoor Alllergies

Original Prescription Strength

Allergy Relief

FEXOFENADINE HYDROCHLORIDE
TABLETS USP, 180 MG

24 Hour Relief of:

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy nose or throat

Non-Drowsy 24 HOUR

Actual Bottle Size on Bottom Panel

Package Contains One Bottle

40 TABLETS 180 mg EACH

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-052(NDC:55111-784)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
magnesium stearate (UNII: 70097M6I30)
mannitol (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
polyethylene glycol 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	194;R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-052-30	1 in 1 CARTON	04/01/2011
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69842-052-90	1 in 1 CARTON	04/01/2011
2		90 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69842-052-40	1 in 1 CARTON	05/01/2013
3		40 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69842-052-45	1 in 1 CARTON	04/01/2011
4		45 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 69842-052-60	2 in 1 CARTON	04/01/2011
5		60 in 1 CARTON; Type 0: Not a Combination Product
6	NDC: 69842-052-18	1 in 1 CARTON	02/01/2013
6		180 in 1 CARTON; Type 0: Not a Combination Product
7	NDC: 69842-052-02	1 in 1 CARTON	04/01/2015
7		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC: 69842-052-07	1 in 1 CARTON	04/01/2011
8		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC: 69842-052-15	3 in 1 CARTON	04/01/2011
9		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC: 69842-052-29	3 in 1 CARTON	04/01/2011
10		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076502	04/01/2011

Labeler - CVS Health Corp. (062312574)