DOSAGE & ADMINISTRATION SECTION.


Directions. for adults 18 years of age and olderthis product is to be used once day (every 24 hours), every day for 14 daysit may take to days for full effect; some people get complete relief of symptoms within 24 hours14-Day Course of Treatmentswallow tablet with glass of water before eating in the morningtake every day for 14 daysdo not take more than tablet daydo not use for more than 14 days unless directed by your doctorswallow whole. Do not chew or crush tablets.Repeated 14-Day Courses (if needed)you may repeat 14-day course every monthsdo not take for more than 14 days or more often than every months unless directed by doctorchildren under 18 years of age: ask doctor. Heartburn in children may sometimes be caused by serious condition.. for adults 18 years of age and older. this product is to be used once day (every 24 hours), every day for 14 days. it may take to days for full effect; some people get complete relief of symptoms within 24 hours. swallow tablet with glass of water before eating in the morning. take every day for 14 days. do not take more than tablet day. do not use for more than 14 days unless directed by your doctor. swallow whole. Do not chew or crush tablets.. you may repeat 14-day course every months. do not take for more than 14 days or more often than every months unless directed by doctor. children under 18 years of age: ask doctor. Heartburn in children may sometimes be caused by serious condition.

INACTIVE INGREDIENT SECTION.


Inactive ingredients. crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide.

INDICATIONS & USAGE SECTION.


Use. treats frequent heartburn (occurs or more days week)not intended for immediate relief of heartburn; this drug may take to days for full effect. treats frequent heartburn (occurs or more days week). not intended for immediate relief of heartburn; this drug may take to days for full effect.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient (in each tablet). Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP).

OTC - ASK DOCTOR SECTION.


Ask doctor before use if you have:. had heartburn over months. This may be sign of more serious condition.frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain. had heartburn over months. This may be sign of more serious condition.. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are. taking prescription drug. Acid reducers may interact with certain prescription drugs.

OTC - DO NOT USE SECTION.


Do not use if you have:. trouble or pain swallowing food, vomiting with blood, or bloody or black stoolsheartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednessfrequent chest pain These may be signs of serious condition. See your doctor.. 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.


If pregnant or breast-feeding,. ask health professional before use.

OTC - PURPOSE SECTION.


Purpose. Acid reducer.

OTC - QUESTIONS SECTION.


Questions. Call 1-800-645-2158 Distributed by: RUGBY(R) LABORATORIES 17177N Laurel Park Drive, Suite 233Livonia, MI 48152 Made in India Code: TS/DRUGS/22/2009.

OTC - STOP USE SECTION.


Stop use and ask doctor if:. your heartburn continues or worsensyou need to take this product for more than 14 days you need to take more than course of treatment every monthsyou get diarrheayou develop rash or joint pain. your heartburn continues or worsens. you need to take this product for more than 14 days you need to take more than course of treatment every months. you get diarrhea. you develop rash or joint pain.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 20 mg (14 Tablet Bottle). Rugby(R) NDC 0536-1322-88 Omeprazole Delayed-Release Tablets 20 mg Acid Reducer 24 Hour Treats Frequent Heartburn14 Tablets One 14-day course of treatment May take to days for full effect. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 20 mg (14 Tablet Bottle).

SPL UNCLASSIFIED SECTION.


Tips for Managing Heartburn. Do not lie flat or bend over after eatingDo not wear tight-fitting clothing around the stomachDo not eat before bedtimeRaise the head of your bedAvoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetablesEat slowly and avoid big mealsIf overweight, lose weightQuit smoking. Do not lie flat or bend over after eating. Do not wear tight-fitting clothing around the stomach. Do not eat before bedtime. Raise the head of your bed. Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables. Eat slowly and avoid big meals. If overweight, lose weight. Quit smoking.

STORAGE AND HANDLING SECTION.


Other information. read the directions and warnings before usekeep the carton. It contains important information.store at 20o to 25oC (68o to 77o F) and protect from moisture. read the directions and warnings before use. keep the carton. It contains important information.. store at 20o to 25oC (68o to 77o F) and protect from moisture.

WARNINGS SECTION.


Warnings. Allergy alert: Do not use if you are allergic to omeprazole.