Omeprazole Delayed-Release Tablets, 20 mg

Active Ingredients And Purpose

Active ingredient(in each tablet)

Omeprazole USP 20 mg

Purpose

Acid reducer

Uses

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

Warnings

Allergy alert: do not use if you are allergic to omeprazole • omeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away.

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 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

Directions And Dosage

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 Label Information

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.

Principal Display Panel - Foil

62756-377-40 Omeprazole Delayed-Release Tablet 20 mg Acid Reducer PUSH THROUGH Take 1 tablet a day fo 14 days Mfg. by: Sun Pharmaceutical Ind Ltd ., India. Dist. by: Sun Pharmaceutical Ind Inc ., NJ 08512 PGPF0520A

Principal Display Panel - Blister Carton

NDC 62756-377-96 Compare to Prilosec OTC ® * Treats Frequent Heartburn! (24 HR) Compare to Prilosec OTC ® * Omeprazole Delayed-release Tablets 20 mg Acid Reducer SWALLOW - DO NOT CHEW 28 (2 x 14) Unit-Dose Tablets TWO 14-DAY COURSES OF TREATMENT May take 1 to 4 days for full effect