Allegra Hives 24hr

Allegra Hives 24hr
SPL v9
SPL
SPL Set ID 490b4c5f-448b-4563-928b-837117b59b9f
Route
ORAL
Published
Effective Date 2024-06-01
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 Brown Iron Oxide Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 018;E Shape: oval Color: orange Size: 17 mm Score: 1
Marketing Status
NDA Active Since 2022-06-06

Description

Allegra Hives 24HR tablet 180 mg Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Allegra Hives 24HR tablet 180 mg Drug Facts

Uses

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

Section 42229-5

Allegra Hives 24HR tablet 180 mg

Drug Facts

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 ■ wheezing or problems breathing ■ drooling

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.

Directions
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
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.

Other Information

■(if blister) safety sealed: do not use if carton is opened or if individual blister units are torn or opened

■(on the carton if bottle) safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

■(if bottle) safety sealed: do not use if carton was opened or if printed foil inner 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

Principal Display Panel

Allegra

Hives

fexofenadine HCI tablet

180 mg/antihistamine

24 HR

30 TABLETS

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.

Active Ingredient (in Each Tablet)

Fexofenadine HCl 180 mg

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


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Allegra Hives 24HR tablet 180 mg

Drug Facts

Purpose

Antihistamine

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 ■ wheezing or problems breathing ■ drooling

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.

Directions
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
Do Not Use (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.

Other Information (Other information)

■(if blister) safety sealed: do not use if carton is opened or if individual blister units are torn or opened

■(on the carton if bottle) safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

■(if bottle) safety sealed: do not use if carton was opened or if printed foil inner 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Allegra

Hives

fexofenadine HCI tablet

180 mg/antihistamine

24 HR

30 TABLETS

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)

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.

■ symptoms do not improve after 3 days of treatment

■ the hives have lasted more than 6 weeks

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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCl 180 mg

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.

■ hives that are an unusual color, look bruised or blistered

■ hives that do not itch


Advanced Ingredient Data


Raw Label Data

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