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Fexofenadine by Wockhardt USA LLC.

Medically reviewed on March 5, 2018

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 30mgFEXOFENADINE HYDROCHLORIDE 60mgFEXOFENADINE HYDROCHLORIDE 180mg
Labeler: Wockhardt USA LLC.
NDC Code: 64679-744

Fexofenadine Tablets

Active ingredient (in each tablet)

For 30 mg:

Fexofenadine HCl 30 mg

For 60 mg:

Fexofenadine HCl 60 mg

For 180 mg:

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

  • trouble swallowing                    
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

●   to prevent hives from any known cause such as:

  • foods
  • insect stings
  • medicines
  • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

●   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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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

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 open or if individual blister unit is torn or open
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

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

Questions or comments?

Call toll-free 1-800-346-6854

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FEXOFENADINE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-744
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
POVIDONE K30 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (round) Size7mm
FlavorImprint CodeW;30
Contains    
Packaging
#Item CodePackage Description
1NDC:64679-744-071 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
1NDC:64679-744-066 TABLET, FILM COATED (6 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911202/08/2012
FEXOFENADINE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-982
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
POVIDONE K30 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (Capsule) Size11mm
FlavorImprint CodeW;982
Contains    
Packaging
#Item CodePackage Description
1NDC:64679-982-072 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
1NDC:64679-982-066 TABLET, FILM COATED (6 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911202/08/2012
FEXOFENADINE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-987
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
POVIDONE K30 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (Capsule) Size17mm
FlavorImprint CodeW;987
Contains    
Packaging
#Item CodePackage Description
1NDC:64679-987-081 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
1NDC:64679-987-075 TABLET, FILM COATED (5 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911202/08/2012
Labeler - Wockhardt USA LLC. (170508365)
Registrant - Wockhardt USA LLC. (170508365)
Establishment
NameAddressID/FEIOperations
Wockhardt Limited676257570Manufacture

 
Wockhardt USA LLC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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