FEXOFENADINE HYDROCHLORIDE tablet, film coated

Fexofenadine Hydrochloride by

Drug Labeling and Warnings

Fexofenadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Hetero Labs Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

(in each tablet)
Fexofenadine Hydrochloride USP, 30 mg
Fexofenadine Hydrochloride USP, 60 mg
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 DOCTOR IF

an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY/BREASTFEEDING

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

30 mg

• adults and children 12 years of age and over: take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours
• children 6 to under 12 years of age: take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
• children under 6 years of age: do not use
• adults 65 years of age and older: ask a doctor
• consumers with kidney disease: ask a doctor

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

• Tamper Evident: Do not use if printed foil seal under cap is missing
• This unit-dose package is not child-resistant
• store between 20º and 25ºC (68º and 77ºF) 
• protect from excessive moisture

INACTIVE INGREDIENTS

Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

QUESTIONS?

Call 1-866-495-1995

PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Carton

Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Label

Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Foil

Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Carton

Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Carton

Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Label

Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Foil

Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Carton

Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Carton

Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Label

Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Foil

Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Carton

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68554-5061
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	30 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND (biconvex)	Size	6mm
Flavor		Imprint Code	j;42
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68554-5061-0	1 in 1 CARTON	08/23/2016
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68554-5061-1	1 in 1 CARTON	08/23/2016
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 68554-5061-2	1 in 1 CARTON	08/23/2016
3		500 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 68554-5061-5	10 in 1 CARTON	08/23/2016
4	NDC: 68554-5061-4	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 68554-5061-6	22 in 1 CARTON	08/23/2016
5	NDC: 68554-5061-3	10 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	ANDA204097	08/23/2016

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68554-5062
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL (biconvex)	Size	12mm
Flavor		Imprint Code	j;43
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68554-5062-0	1 in 1 CARTON	08/23/2016
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68554-5062-1	1 in 1 CARTON	08/23/2016
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 68554-5062-2	1 in 1 CARTON	08/23/2016
3		500 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 68554-5062-5	7 in 1 CARTON	08/23/2016
4	NDC: 68554-5062-4	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 68554-5062-6	15 in 1 CARTON	08/23/2016
5	NDC: 68554-5062-3	10 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	ANDA204097	08/23/2016

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68554-5063
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE (biconvex)	Size	18mm
Flavor		Imprint Code	j;44
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68554-5063-0	1 in 1 CARTON	08/23/2016
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68554-5063-1	1 in 1 CARTON	08/23/2016
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 68554-5063-2	1 in 1 CARTON	08/23/2016
3		500 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 68554-5063-5	7 in 1 CARTON	08/23/2016
4	NDC: 68554-5063-4	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 68554-5063-6	15 in 1 CARTON	08/23/2016
5	NDC: 68554-5063-3	10 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	ANDA204097	08/23/2016

Labeler - Hetero Labs Limited (917261950)