Pentrexcilina

Pentrexcilina
SPL v3
SPL
SPL Set ID b452bca6-2c51-d0a1-e053-2995a90aff67
Route
ORAL
Published
Effective Date 2020-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: rectangle Color: white Size: 9 mm Score: 2
Marketing Status
ANDA Active Since 2020-07-01

Description

Cetirizine HCl 10 mg


Medication Information

Warnings and Precautions

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

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

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

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

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

Keep out of reach of children.

Dosage and Administration
  • adults & children 6 years and over: 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 severe symptoms
  • adults 65 years and over: Ask a doctor
  • children under 6 years: Ask a doctor
  • consumers with liver or kidney disease: Ask a doctor

Description

Cetirizine HCl 10 mg

Section 50565-1

Keep out of reach of children.

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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 10 mg

Section 60561-8

■ store at room temperature between 20-25°C (68-77°F).

■ close cap tightly after use.

■ contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

TAMPER EVIDENT: Do not use if imprinted safety seal is broken or missing.


Structured Label Content

Dosage and Administration (34068-7)
  • adults & children 6 years and over: 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 severe symptoms
  • adults 65 years and over: Ask a doctor
  • children under 6 years: Ask a doctor
  • consumers with liver or kidney disease: Ask a doctor

Warnings and Precautions (34071-1)

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

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

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

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

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

Keep out of reach of children.

Section 50565-1 (50565-1)

Keep out of reach of children.

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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 10 mg

Section 60561-8 (60561-8)

■ store at room temperature between 20-25°C (68-77°F).

■ close cap tightly after use.

■ contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

TAMPER EVIDENT: Do not use if imprinted safety seal is broken or missing.


Advanced Ingredient Data


Raw Label Data

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