ALLERGY 24-HR- fexofenadine hydrochloride tablet, film coated

ALLERGY 24-HR by

Drug Labeling and Warnings

ALLERGY 24-HR by is a Otc medication manufactured, distributed, or labeled by Wockhardt USA LLC., Wockhardt Limited, Patheon Puerto Rico, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

For 30 mg:

Fexofenadine HCl 30 mg

For 60 mg:

Fexofenadine HCl 60 mg

For 180 mg:

Fexofenadine HCl 180 mg

OTC - PURPOSE SECTION

Antihistamine

USAGE

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.

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

For 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

For 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

For 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 inner seal imprinted with "Sealed for Your Protection" is missing or torn
• safety sealed: do not use if carton is opened or if individual blister unit is torn or open
• store between 20° and 25°C (68° and 77°F)
• protect from excessive moisture

INACTIVE INGREDIENT

For 30 mg

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

For 60 mg

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

For 180 mg

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

Questions or comments?

Call toll-free 1-800-346-6854

Manufactured by:

Patheon Puerto Rico, Inc.,

Manati, PR 00674

Distributed by:

Wockhardt USA LLC

20 Waterview Blvd.

Parippany, NJ 07054

USA.

Rev.06-15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fexofenadine hydrochloride

Film-coated Tablets

Indoor and Outdoor Allergies – 24 hours

180 mg

30 tablets bottle pack

Fexofenadine hydrochloride

Film-coated Tablets

Indoor and Outdoor Allergies – 24 hours

180 mg

90 tablets bottle pack

Fexofenadine hydrochloride

Film-coated Tablets

Indoor and Outdoor Allergies – 24 hours

180 mg

5 tablets blister carton

INGREDIENTS AND APPEARANCE

ALLERGY 24-HR 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64679-744
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	W;30
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64679-744-09	1 in 1 CARTON	02/08/2012
1	NDC: 64679-744-08	6 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	ANDA079112	02/08/2012

ALLERGY 24-HR 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64679-982
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (light peach to peach)	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	W982
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64679-982-09	2 in 1 CARTON	02/08/2012
1	NDC: 64679-982-08	6 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	ANDA079112	02/08/2012

ALLERGY 24-HR 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64679-987
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (light peach to peach)	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	W987
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64679-987-10	1 in 1 CARTON	02/08/2012
1	NDC: 64679-987-09	5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 64679-987-11	3 in 1 CARTON	02/08/2012
2	NDC: 64679-987-09	5 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 64679-987-05	2000 in 1 POUCH; Type 0: Not a Combination Product	02/08/2012
4	NDC: 64679-987-20	1 in 1 CARTON	02/08/2012
4	NDC: 64679-987-12	30 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 64679-987-24	1 in 1 CARTON	02/08/2012
5	NDC: 64679-987-16	90 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 64679-987-14	2 in 1 CARTON	02/08/2012
6	NDC: 64679-987-13	45 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 64679-987-17	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2012
8	NDC: 64679-987-22	1 in 1 CARTON	02/08/2012
8	NDC: 64679-987-13	45 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	ANDA079112	02/08/2012

Labeler - Wockhardt USA LLC. (170508365)

Registrant - Wockhardt Limited (650069115)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		676257570	ANALYSIS(64679-744, 64679-982, 64679-987) , MANUFACTURE(64679-744, 64679-982, 64679-987) , LABEL(64679-744, 64679-982, 64679-987) , PACK(64679-744, 64679-982, 64679-987)

Establishment
Name	Address	ID/FEI	Business Operations
Patheon Puerto Rico, Inc.		143814544	ANALYSIS(64679-982, 64679-987) , LABEL(64679-982, 64679-987) , MANUFACTURE(64679-982, 64679-987) , PACK(64679-982, 64679-987)