Omeprazole Delayed-release Tablets, 20 mg

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole USP 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

• treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment • swallow 1 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets. Repeated 14-Day Courses (if needed) • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Other information

STORAGE AND HANDLING SECTION

• read the directions and warnings before use • keep the carton. It contains important information. • store at 20 to 25° C (68 to 77° F) and protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide. The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-818-4555 weekdays.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India.

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

† Compare To Prilosec OTC ® NDC 51660-029-27 Omeprazole Delayed-release Tablets 20 mg / Acid Reducer SWALLOW- DO NOT CHEW Treats FREQUENT Heartburn! 24 HR 28 TABLETS Two 14-day courses of treatment May take 1 to 4 days for full effect ohm ®