Cetirizine Hydrochloride

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl, USP 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE. store between 20° to 25° C (68° to 77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

call 1-800-406-7984

HOW SUPPLIED

HOW SUPPLIED SECTION

Cetirizine HCL 10mg: 10 mg white, rectangle (rounded-off), tablets, debossed "RI52" on obverse and plain on reverse. They are available as follows: Bottles of 7: NDC 55289-995-07 Bottles of 10: NDC 55289-995-10 Bottles of 30: NDC 55289-995-30

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine HCl Tablets, USP 10 mg ANTIHISTAMINE