Omeprazole Delayed-release Tablets, 20 mg
Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ANHYDROUS LACTOSE HYPROMELLOSE, UNSPECIFIED HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MPA.S) FERRIC OXIDE RED FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MONOETHANOLAMINE METHYLCELLULOSE (1500 MPA.S) PROPYLENE GLYCOL SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM STEARATE SODIUM STEARYL FUMARATE SODIUM LAURYL SULFATE TRIETHYL CITRATE TALC TITANIUM DIOXIDE AMMONIA FERROSOFERRIC OXIDE BUTYL ALCOHOL SHELLAC brownish pink biconvex 20
Drug Facts
Active ingredient(in each tablet) Omeprazole USP 20 mg
Purpose Acid reducer
Use •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
Allergy alert Do not use if you are allergic to omeprazole.
Do not use if you have •trouble or pain swallowing food, vomiting with blood, or bloody or black stools •heartburn with lightheadedness, sweating or dizziness •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness •frequent chest pain These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have •had heartburn over 3 months. This may be a sign of a more serious condition. •frequent wheezing, particularly with heartburn •unexplained weight loss •nausea or vomiting •stomach pain
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Stop use and ask a doctor if •your heartburn continues or worsens •you need to take this product for more than 14 days •you need to take more than 1 course of treatment every 4 months •you get diarrhea •you develop a rash or joint pain
If pregnant or breast-feeding, 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).
Directions •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 •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 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? Call toll free 1-800-818-4555 weekdays.
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 †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® PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton