OTC Medication Information: Fexofenadine

FEXOFENADINE- fexofenadine hydrochloride tablet, film coated
Wockhardt USA LLC.

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

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

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 inner seal imprinted with “Sealed for Your Protection” is missing or torn
  • 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

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Label
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Carton
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Blister
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FEXOFENADINE fexofenadine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64679-744
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (round) Size 7mm
Flavor Imprint Code W;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-744-09 1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON contains a BLISTER PACK (64679-744-08)
1 NDC:64679-744-08 6 TABLET, FILM COATED (6 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (64679-744-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079112 02/08/2012
FEXOFENADINE fexofenadine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64679-982
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (Capsule) Size 11mm
Flavor Imprint Code W;982
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-982-09 2 BLISTER PACK (2 BLISTER PACK) in 1 CARTON contains a BLISTER PACK (64679-982-08)
1 NDC:64679-982-08 6 TABLET, FILM COATED (6 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (64679-982-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079112 02/08/2012
FEXOFENADINE fexofenadine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64679-987
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE 180 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (Capsule) Size 17mm
Flavor Imprint Code W;987
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-987-05 2000 TABLET, FILM COATED (2000 TABLET) in 1 POUCH None
2 NDC:64679-987-12 1 BOTTLE (1 BOTTLE) in 1 CARTON contains a BOTTLE
2 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE This package is contained within the CARTON (64679-987-12)
3 NDC:64679-987-13 1 BOTTLE (1 BOTTLE) in 1 CARTON contains a BOTTLE
3 45 TABLET, FILM COATED (45 TABLET) in 1 BOTTLE This package is contained within the CARTON (64679-987-13)
4 NDC:64679-987-14 2 BOTTLE (2 BOTTLE) in 1 CARTON contains a BOTTLE
4 45 TABLET, FILM COATED (45 TABLET) in 1 BOTTLE This package is contained within the CARTON (64679-987-14)
5 NDC:64679-987-10 1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON contains a BLISTER PACK (64679-987-09)
5 NDC:64679-987-09 5 TABLET, FILM COATED (5 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (64679-987-10)
6 NDC:64679-987-11 3 BLISTER PACK (3 BLISTER PACK) in 1 CARTON contains a BLISTER PACK (64679-987-09)
6 NDC:64679-987-09 5 TABLET, FILM COATED (5 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (64679-987-11)
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 USA LLC. (170508365)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 Manufacture

Revised: 05/2012 Wockhardt USA LLC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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