TOPCARE FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet, film coated

Topcare fexofenadine hydrochloride by

Drug Labeling and Warnings

Topcare fexofenadine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Fexofenadine HCl 60 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 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

Other information

• do not use if blister unit is broken or torn
• store at 20°-25°C (68°-77°F)
• protect from excessive moisture
• this product meets the requirements of USP Dissolution Test 3

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

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ORIGINAL PRESCRIPTION STRENGTH

12-HOUR

Fexofenadine Hydrochloride Tablets, 60 mg

ANTIHISTAMINE

Allergy

INDOOR & OUTDOOR ALLERGIES

Relief of:

Sneezing

Runny nose

Itchy, watery eyes

Itchy nose or throat

NON-DROWSY

actual size

COMPARE TO ALLEGRA® ALLERGY active ingredient

60 mg EACH

Fexofenadine Hydrochloride Carton Image 1

Fexofenadine Hydrochloride Carton Image 2

INGREDIENTS AND APPEARANCE

TOPCARE FEXOFENADINE HYDROCHLORIDE 
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-425
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (Peach)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	93;7252
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-425-53	2 in 1 CARTON
1		6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076447	09/02/2011

Labeler - Topco Associates LLC (006935977)