Cetirizine Hydrochloride Tablets

Cetirizine Hydrochloride Tablets
SPL v5
SPL
SPL Set ID 2b839e8b-f4ac-4379-ae50-ace4008705d8
Route
ORAL
Published
Effective Date 2010-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Polyvinyl Alcohol Polyethylene Glycol Povidone Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: IP;46 Shape: oval Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2010-01-21

Description

Drug Facts

Indications and Usage

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

Purpose

Antihistamine

Dosage and Administration

Adults andchildren 6years andover One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms Adults 65years andover Ask a doctor Childrenunder 6 yearsof age ask a doctor Consumerswith liver orkidney disease ask a doctor


Medication Information

Indications and Usage

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

Purpose

Antihistamine

Dosage and Administration
Adults andchildren 6years andover One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms
Adults 65years andover Ask a doctor
Childrenunder 6 yearsof age ask a doctor
Consumerswith liver orkidney disease ask a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Stop Use

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

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.

Ask Doctor

Ask a doctor before use if you have

• liver or 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

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 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 its ingredients or to an antihistamine containing hydroxyzine.

When Using

When using this product

• drowsiness may occur

• avoid alcoholic drinks

• alcohol, sedatives, and tranquilizers may increase drowsiness

• be careful when driving a motor vehicle or operating machinery

Otc Questions

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9AM-5PM EST

Active Ingredient

(in each tablet)

Cetirizine HCl 10 mg

Other Information

Other information

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

Inactive Ingredient

Inactive Ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

Ask Doctor/pharmacist

Ask a doctor of pharmacist before use if you are taking tranquilizers or sedatives.

Pregnancy Or Breast Feeding

If pregnant or breast-feeding:

• if breast-feeding: not recommended

• if pregnant: 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.

Package Label.principal Display Panel

Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Purpose (PURPOSE)

Antihistamine

Stop Use (STOP USE)

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

Warnings (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.

Ask Doctor (ASK DOCTOR)

Ask a doctor before use if you have

• liver or 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

Do Not Use (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 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 its ingredients or to an antihistamine containing hydroxyzine.

When Using (WHEN USING)

When using this product

• drowsiness may occur

• avoid alcoholic drinks

• alcohol, sedatives, and tranquilizers may increase drowsiness

• be careful when driving a motor vehicle or operating machinery

Otc Questions (OTC - QUESTIONS)

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9AM-5PM EST

Active Ingredient (ACTIVE INGREDIENT)

(in each tablet)

Cetirizine HCl 10 mg

Other Information (OTHER INFORMATION)

Other information

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

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

Ask Doctor/pharmacist (ASK DOCTOR/PHARMACIST)

Ask a doctor of pharmacist before use if you are taking tranquilizers or sedatives.

Indications and Usage (INDICATIONS AND USAGE)

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

Dosage and Administration (DOSAGE AND ADMINISTRATION)
Adults andchildren 6years andover One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms
Adults 65years andover Ask a doctor
Childrenunder 6 yearsof age ask a doctor
Consumerswith liver orkidney disease ask a doctor
Pregnancy Or Breast Feeding (PREGNANCY OR BREAST FEEDING)

If pregnant or breast-feeding:

• if breast-feeding: not recommended

• if pregnant: ask a health professional before use.

Keep Out of Reach of Children (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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

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