Fexofenadine HCL by Camber Consumer Care / Hetero Labs Limited Unit V FEXOFENADINE HCL tablet

Fexofenadine HCL by

Drug Labeling and Warnings

Fexofenadine HCL by is a Otc medication manufactured, distributed, or labeled by Camber Consumer Care, Hetero Labs Limited Unit V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S), in each tablet

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 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.

DIRECTIONS

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

•  Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.
•  store between 20° and 25°C (68° and 77°F)
•  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 OR COMMENTS

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418

PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Tablets, USP 180 mg 30s Container Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 30s Carton Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 100s Container Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 100s Carton Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 500s Container Label

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL 
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69230-300
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)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	J;44
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69230-300-30	1 in 1 CARTON	08/19/2016
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69230-300-01	1 in 1 CARTON	08/19/2016
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69230-300-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204097	08/19/2016

FEXOFENADINE HCL 
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69230-301
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)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	J;43
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69230-301-30	1 in 1 CARTON	08/19/2016
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69230-301-01	1 in 1 CARTON	08/19/2016
2		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204097	08/19/2016

Labeler - Camber Consumer Care (079539968)

Establishment
Name	Address	ID/FEI	Business Operations
Hetero Labs Limited Unit V		650452530	ANALYSIS(69230-300, 69230-301) , MANUFACTURE(69230-300, 69230-301)