Gencare Hives Relief 

Gencare Hives Relief 
SPL v1
SPL
SPL Set ID ad0944f1-c5af-42cf-96c9-3140cbda66d8
Route
ORAL
Published
Effective Date 2026-01-21
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 Ferric Oxide Red Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
ANDA Active Since 2026-01-21

Description

Fexofenadine HCl 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl 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.

Section 50565-1

Keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Section 51945-4

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

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

■drooling

■wheezing or problems breathing

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 180mg 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

■ Store between 20°C and 25 °C (68 °and 77°F)

■ Protect from excessive moisture

Inactive Ingredient

Colloidal Silicon Dioxide, Croscarmellose Sodium Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol/macrogol, Povidone, Pregelatinized Starch, Red iron oxide, Silica, Titanium dioxide, Yellow iron oxide.

Questions Or Comments

Call +1 (732) 994-2808 or email [email protected]

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

Active Ingredient (in Each Caplet)

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 50565-1 (50565-1)

Keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

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

■drooling

■wheezing or problems breathing

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 180mg 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)

■ Store between 20°C and 25 °C (68 °and 77°F)

■ Protect from excessive moisture

Inactive Ingredient (Inactive ingredient)

Colloidal Silicon Dioxide, Croscarmellose Sodium Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol/macrogol, Povidone, Pregelatinized Starch, Red iron oxide, Silica, Titanium dioxide, Yellow iron oxide.

Questions Or Comments (Questions or comments)

Call +1 (732) 994-2808 or email [email protected]

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

Active Ingredient (in Each Caplet) (Active Ingredient (in each caplet))

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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