Allergy & Hives Relief

Allergy & Hives Relief
SPL v5
SPL
SPL Set ID 00ef8467-30a0-7579-e063-6294a90a75af
Route
ORAL
Published
Effective Date 2024-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Ferric Oxide Yellow Croscarmellose Sodium Ferrosoferric Oxide Ferric Oxide Red Lactose Monohydrate Microcrystalline Cellulose Hypromellose 2910 (15 Mpa.s) Silicon Dioxide Titanium Dioxide Magnesium Stearate Starch, Corn Polyethylene Glycol 6000

Identifiers & Packaging

Pill Appearance
Imprint: G6 Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2024-03-27

Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

Uses

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

Directions

adults and children 12 years of age and over: take one 180 mg tablet with water every 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

 safety sealed: do not use if foil printed with granules logo under bottle cap is opened or torn.

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

 protect from excessive moisture

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

Principal Display Panel

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

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

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

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.

Active Ingredient (in Each Tablet)

Fexofenadine HCl USP, 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.

Purpose

Antihistamine

Directions

adults and children 12 years of age and over: take one 180 mg tablet with water every 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)

 safety sealed: do not use if foil printed with granules logo under bottle cap is opened or torn.

 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 black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

Principal Display Panel (Principal display panel)

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

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

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.

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

ask a health professional before use.

Not A Substitute for Epinephrine. (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.

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

Fexofenadine HCl USP, 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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