Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID d3411eec-05b1-49b3-86e8-bc47ac0ef6b7
Route
ORAL
Published
Effective Date 2023-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Lactose Monohydrate Croscarmellose Sodium Silicon Dioxide Cellulose, Microcrystalline Hypromellose, Unspecified Titanium Dioxide Polyethylene Glycol, Unspecified Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: rectangle Color: white Size: 9 mm Score: 2
Marketing Status
ANDA Active Since 2023-12-07

Description

Cetirizine HCl 10mg


Medication Information

Warnings and Precautions

Do not useif you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine

Ask a doctor before useif you have liver or kidney disease.  Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this productdrowsiness may occur.  Avoid alcoholic drinks.  Alcohol, sedatives and tranquilizers may increase drowsiness.  Be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctorif an allergic reaction to this product occurs.  Seek medical help right away.

Indications and Usage

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

runny nose, sneezing, itchy/watery eyes, itching of the nose or throat

Dosage and Administration

Adult and children over 6 years old:One 10mg tablet once daily: no more than one 10mg tablet in 24 hours.  A 5mg product may be appropriate for less severe symptoms

Adults 65 years and over:ask a doctor

Children under 6 years of age:ask a doctor

Consumers with liver or kidney disease: ask a doctor

Description

Cetirizine HCl 10mg

Section 42228-7

If pregnant of breast-feeding:

If breast-feeding: not recommended.

If pregnant: ask a health professional before use.

Section 50565-1

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away

Section 51727-6

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Section 51945-4
Section 55105-1

Antihistamine

Section 55106-9

Cetirizine HCl 10mg

Section 60561-8

Store between 20-25 degrees celcius (68-77 degrees farhenheit).

Do not use if imprinted seal under bottle cap is broken or missing

You may report side effects 1-888-952-0050


Structured Label Content

Indications and Usage (34067-9)

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

runny nose, sneezing, itchy/watery eyes, itching of the nose or throat

Dosage and Administration (34068-7)

Adult and children over 6 years old:One 10mg tablet once daily: no more than one 10mg tablet in 24 hours.  A 5mg product may be appropriate for less severe symptoms

Adults 65 years and over:ask a doctor

Children under 6 years of age:ask a doctor

Consumers with liver or kidney disease: ask a doctor

Warnings and Precautions (34071-1)

Do not useif you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine

Ask a doctor before useif you have liver or kidney disease.  Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this productdrowsiness may occur.  Avoid alcoholic drinks.  Alcohol, sedatives and tranquilizers may increase drowsiness.  Be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctorif an allergic reaction to this product occurs.  Seek medical help right away.

Section 42228-7 (42228-7)

If pregnant of breast-feeding:

If breast-feeding: not recommended.

If pregnant: ask a health professional before use.

Section 50565-1 (50565-1)

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away

Section 51727-6 (51727-6)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Cetirizine HCl 10mg

Section 60561-8 (60561-8)

Store between 20-25 degrees celcius (68-77 degrees farhenheit).

Do not use if imprinted seal under bottle cap is broken or missing

You may report side effects 1-888-952-0050


Advanced Ingredient Data


Raw Label Data

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