Cetirizine 10mg 680

Cetirizine 10mg 680
SPL v1
SPL
SPL Set ID 6a707324-b32b-9741-e053-2a91aa0a2af2
Route
ORAL
Published
Effective Date 2018-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: 4H2 Shape: oval Color: white Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2018-02-14

Description

Cetirizine HCL 10MG


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 tranquilizers or sedatives.

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:



if breast-feeding: not recommended



if pregnant: ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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

adults and 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 of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Description

Cetirizine HCL 10MG

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 51727-6

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Section 51945-4

Section 55105-1

Antihistamine

Section 55106-9

Cetirizine HCL 10MG


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)

adults and 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 of age

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 tranquilizers or sedatives.

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:



if breast-feeding: not recommended



if pregnant: ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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. (1-800-222-1222)

Section 51727-6 (51727-6)

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Cetirizine HCL 10MG


Advanced Ingredient Data


Raw Label Data

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