OTC Medication Information: ALLERGY 24-HR

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

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 Bottle Pack
(click image for full-size original)

Fexofenadine hydrochloride

Film-coated Tablets

Indoor and Outdoor Allergies – 24 hours

180 mg

90 tablets bottle pack

90T-Bottle Pack
(click image for full-size original)

Fexofenadine hydrochloride

Film-coated Tablets

Indoor and Outdoor Allergies – 24 hours

180 mg

5 tablets blister carton

5T-Blister pack carton
(click image for full-size original)
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 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
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code W;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-744-09 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (64679-744-08)
1 NDC:64679-744-08 6 TABLET, FILM COATED 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
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 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
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:64679-982-09 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK (64679-982-08)
1 NDC:64679-982-08 6 TABLET, FILM COATED 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
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 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
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
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 Multilevel Packaging
1 NDC:64679-987-10 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (64679-987-09)
1 NDC:64679-987-09 5 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (64679-987-10)
2 NDC:64679-987-11 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (64679-987-09)
2 NDC:64679-987-09 5 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (64679-987-11)
3 NDC:64679-987-05 2000 TABLET, FILM COATED in 1 POUCH None
4 NDC:64679-987-20 1 BOTTLE in 1 CARTON contains a BOTTLE (64679-987-12)
4 NDC:64679-987-12 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (64679-987-20)
5 NDC:64679-987-24 1 BOTTLE in 1 CARTON contains a BOTTLE (64679-987-16)
5 NDC:64679-987-16 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (64679-987-24)
6 NDC:64679-987-14 2 BOTTLE in 1 CARTON contains a BOTTLE (64679-987-13)
6 NDC:64679-987-13 45 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (64679-987-14)
7 NDC:64679-987-17 1000 TABLET, FILM COATED in 1 BOTTLE None
8 NDC:64679-987-22 1 BOTTLE in 1 CARTON contains a BOTTLE (64679-987-13)
8 NDC:64679-987-13 45 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (64679-987-22)
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 Operations
Wockhardt Limited 676257570 ANALYSIS (64679-744), ANALYSIS (64679-982), ANALYSIS (64679-987), MANUFACTURE (64679-744), MANUFACTURE (64679-982), MANUFACTURE (64679-987), LABEL (64679-744), LABEL (64679-982), LABEL (64679-987), PACK (64679-744), PACK (64679-982), PACK (64679-987)
Establishment
Name Address ID/FEI Operations
Patheon Puerto Rico, Inc. 143814544 ANALYSIS (64679-982), ANALYSIS (64679-987), LABEL (64679-982), LABEL (64679-987), MANUFACTURE (64679-982), MANUFACTURE (64679-987), PACK (64679-982), PACK (64679-987)

Revised: 11/2019 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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