ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS

ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS

Drug Labeling and Warnings

Drug Details

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ALLERGY 24-HR- fexofenadine hydrochloride tablet, film coated 
Wockhardt USA LLC.

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ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS

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

30T Label - 180 mg

Fexofenadine hydrochloride

Film-coated Tablets

Indoor and Outdoor Allergies – 24 hours

180 mg

90 tablets bottle pack

90T Label - 180 mg

Fexofenadine hydrochloride

Film-coated Tablets

Indoor and Outdoor Allergies – 24 hours

180 mg

5 tablets blister carton

5T Blister carton - 180 mg
ALLERGY 24-HR 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64679-744
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
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
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint Code W;30
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64679-744-091 in 1 CARTON02/08/2012
1NDC: 64679-744-086 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911202/08/2012
ALLERGY 24-HR 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64679-982
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
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
ColorBROWN (light peach to peach) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint Code W982
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64679-982-092 in 1 CARTON02/08/2012
1NDC: 64679-982-086 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911202/08/2012
ALLERGY 24-HR 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64679-987
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
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
ColorBROWN (light peach to peach) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint Code W987
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64679-987-101 in 1 CARTON02/08/2012
1NDC: 64679-987-095 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 64679-987-113 in 1 CARTON02/08/2012
2NDC: 64679-987-095 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 64679-987-052000 in 1 POUCH; Type 0: Not a Combination Product02/08/2012
4NDC: 64679-987-201 in 1 CARTON02/08/2012
4NDC: 64679-987-1230 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 64679-987-241 in 1 CARTON02/08/2012
5NDC: 64679-987-1690 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC: 64679-987-142 in 1 CARTON02/08/2012
6NDC: 64679-987-1345 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC: 64679-987-171000 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2012
8NDC: 64679-987-221 in 1 CARTON02/08/2012
8NDC: 64679-987-1345 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911202/08/2012
Labeler - Wockhardt USA LLC. (170508365)
Registrant - Wockhardt Limited (650069115)
Establishment
NameAddressID/FEIBusiness Operations
Wockhardt Limited676257570ANALYSIS(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
NameAddressID/FEIBusiness Operations
Patheon Puerto Rico, Inc.143814544ANALYSIS(64679-982, 64679-987) , LABEL(64679-982, 64679-987) , MANUFACTURE(64679-982, 64679-987) , PACK(64679-982, 64679-987)

Revised: 12/2018
 
Wockhardt USA LLC.


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