Allegra Allergy

Allegra Allergy
SPL v24
SPL
SPL Set ID b5ce28f8-f6c3-4113-9317-e1c98e5030ef
Route
ORAL
Published
Effective Date 2024-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Titanium Dioxide Brown Iron Oxide

Identifiers & Packaging

Pill Appearance
Imprint: 018;E Shape: oval Color: orange Size: 17 mm Size: 12 mm Score: 1
Marketing Status
NDA Active Since 2011-03-03 Until 2016-04-30

Description

Allegra Allergy Allegra Allergy ® - 12 /24 HOUR Drug Facts

Purpose

Antihistamine

How Supplied

Product: 50090-1234 NDC: 50090-1234-0 30 TABLET, FILM COATED in a BOTTLE, PLASTIC / 1 in a CARTON Product: 50090-1235 Product: 50090-1845


Medication Information

Purpose

Antihistamine

How Supplied

Product: 50090-1234

NDC: 50090-1234-0 30 TABLET, FILM COATED in a BOTTLE, PLASTIC / 1 in a CARTON

Product: 50090-1235

Product: 50090-1845

Description

Allegra Allergy Allegra Allergy ® - 12 /24 HOUR Drug Facts

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose

  • sneezing

  • itchy, water eyes

  • itching of the nose or throat
Section 42229-5

Allegra Allergy

Allegra Allergy ® - 12 /24 HOUR

Drug Facts

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients

Allegra 12 Hour
 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
Allegra 24 Hour
 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
Active Ingredient

(in each tablet)

12 Hour Tablet: Fexofenadine HCl 60 mg

24 Hour Tablet: Fexofenadine HCl 180 mg

Other Information
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened or if inner foil seal on bottle is torn or missing

  • store between 20° and 25°C (68° and 77°F)

  • protect from excessive moisture
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Questions Or Comments?

call toll-free 1-800-633-1610 or www.allegra.com



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)
Fexofenadine Hydrochloride
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.

Ask A Doctor Before Use If You Have

kidney disease. Your doctor should determine if you need a different dose.


Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose

  • sneezing

  • itchy, water eyes

  • itching of the nose or throat
Section 42229-5 (42229-5)

Allegra Allergy

Allegra Allergy ® - 12 /24 HOUR

Drug Facts

Purpose

Antihistamine

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients

How Supplied (HOW SUPPLIED)

Product: 50090-1234

NDC: 50090-1234-0 30 TABLET, FILM COATED in a BOTTLE, PLASTIC / 1 in a CARTON

Product: 50090-1235

Product: 50090-1845

Allegra 12 Hour
 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
Allegra 24 Hour
 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
Active Ingredient (Active ingredient)

(in each tablet)

12 Hour Tablet: Fexofenadine HCl 60 mg

24 Hour Tablet: Fexofenadine HCl 180 mg

Other Information (Other information)
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened or if inner foil seal on bottle is torn or missing

  • store between 20° and 25°C (68° and 77°F)

  • protect from excessive moisture
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Questions Or Comments? (Questions or comments?)

call toll-free 1-800-633-1610 or www.allegra.com



When Using This Product (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)
Fexofenadine Hydrochloride (fexofenadine hydrochloride)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney disease. Your doctor should determine if you need a different dose.


Advanced Ingredient Data


Raw Label Data

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