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FDA Drug information

CETIRIZINE HYDROCHLORIDE

Read time: 1 mins
Marketing start date: 28 Apr 2024
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Summary of product characteristics


Warnings

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.

Effective Time

20230112

Version

3

Active Ingredient

Active Ingredients (in each tablet) Purpose Cetirizine HCl 10 mg..............................................................................................Antihistimine

Purpose

Uses 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

Spl Product Data Elements

CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE MAGNESIUM STEARATE STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TITANIUM DIOXIDE HYPROMELLOSES LACTOSE CTN;10

Application Number

ANDA077829

Brand Name

CETIRIZINE HYDROCHLORIDE

Generic Name

CETIRIZINE HYDROCHLORIDE

Product Ndc

61919-429

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

429

Ask Doctor

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

Ask Doctor Or Pharmacist

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

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact Poison Control Center right away.

Questions

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 sever 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

Stop Use

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

When Using

drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary.

Pregnancy Or Breast Feeding

if breast-feeding: not recommended if pregnant: ask a health professional before use.

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Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.