{"active_ingredient":["OTC - ACTIVE INGREDIENT Omeprazole delayed-release tablet, 20 mg"],"dosage_and_administration":["DOSAGE & ADMINISTRATION 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, although 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 chew or crush the tablets do not crush tablets in food do not use for more than 14 days unless directed by your doctor 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."],"effective_time":"20161230","id":"44ec2f95-86e4-0fec-e054-00144ff8d46c","inactive_ingredient":["INACTIVE INGREDIENT carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate"],"indications_and_usage":["INDICATIONS & USAGE 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"],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION DRUG: leader omeprazole GENERIC: Omeprazole DOSAGE: TABLET, DELAYED RELEASE ADMINSTRATION: ORAL NDC: 52125-630-04 ACTIVE INGREDIENT(S): OMEPRAZOLE 20mg in 1 INACTIVE INGREDIENT(S): CARNAUBA WAX FERRIC OXIDE YELLOW HYPROMELLOSES FERRIC OXIDE RED LACTOSE MONOHYDRATE PROPYLENE GLYCOL MONOETHANOLAMINE SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TALC SODIUM STEARATE TITANIUM DIOXIDE TRIETHYL CITRATE COLOR: brown SHAPE: OVAL SCORE: No score SIZE: 17 mm IMPRINT: 20 PACKAGING: 14 in 1 CARTON MM1 MM2"],"purpose":["OTC - PURPOSE Acid reducer"],"questions":["OTC - QUESTIONS 1-800-719-9260"],"set_id":"a73108ba-0146-448d-a761-35bd832b89bd","spl_product_data_elements":["leader omeprazole Omeprazole CARNAUBA WAX FERRIC OXIDE YELLOW HYPROMELLOSES FERRIC OXIDE RED LACTOSE MONOHYDRATE PROPYLENE GLYCOL MONOETHANOLAMINE SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TALC SODIUM STEARATE TITANIUM DIOXIDE TRIETHYL CITRATE OMEPRAZOLE OMEPRAZOLE TABLET, DELAYED RELEASE 20"],"spl_unclassified_section":["SPL UNCLASSIFIED Omeprazole Delayed Release Tablets 20 mg Acid Reducer Please read all of this package insert before taking Omeprazole Delayed Release Tablets 20 mg. Save this to read, as you need. How Omeprazole Delayed Release Tablets 20 mg Work For Your Frequent Heartburn Omeprazole Delayed Release Tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers. Omeprazole Delayed Release Tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid. Omeprazole Delayed Release Tablets 20 mg are to be used once a day (every 24 hours), every day for 14 days. What to Expect When Using Omeprazole Delayed Release Tablets 20 mg Omeprazole Delayed Release Tablets 20 mg are a different type of medicine from antacids and other acid reducers. Omeprazole Delayed Release Tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours. Make sure you take the entire 14 days of dosing to treat your frequent heartburn. Who Should Take Omeprazole Delayed Release Tablets 20 mg This product is for adults (18 years and older) with frequent heartburn- when you have heartburn 2 or more days a week. ■ Children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition. ■ Omeprazole Delayed Release Tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief of heartburn. How to Take Omeprazole Delayed Release Tablets 20 mg 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 chew or crush the tablets. ■ Do not crush tablets in food. ■ Do not use for more than 14 days unless directed by your doctor. It is important not to chew or crush these tablets, or crush the tablets in food. This decreases how well Omeprazole Delayed Release Tablets 20 mg work. When to Take Omeprazole Delayed Release Tablets 20 mg Again You may repeat a 14-day course of therapy every 4 months. When to Talk to Your Doctor Do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Warnings and When to ask Your Doctor 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. 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. ■ 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 ■ frequent wheezing, particularly with heartburn ■ unexplained weight loss ■ nausea or vomiting ■ stomach pain Ask a doctor or pharmacist before use if you are taking ■ warfarin, clopidogrel or cilostazol (blood-thinning medicines) ■ prescription antifungal or anti-yeast medicines ■ diazepam (anxiety medicine) ■ digoxin (heart medicine) ■ tacrolimus (immune system medicine) ■ prescription antiretrovirals (medicines for HIV infection) 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 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) Tips for Managing Heartburn ■ Do not lie flat or bend over soon after eating. ■ Do not eat late at night or just before bedtime. ■ Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables. ■ Eat slowly and do not eat big meals. ■ If you are overweight, lose weight. ■ If you smoke, quit smoking. ■ Raise the head of your bed. ■ Wear loose-fitting clothing around your stomach. How are Omeprazole Delayed Release Tablets 20 mg Sold Omeprazole Delayed Release Tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months. For Questions or Comments About Omeprazole Delayed Release Tablets 20 mg Call 1-800-719-9260 Made in Israel DISTRIBUTED BY PERRIGO® ALLEGAN, MI 49010 Manufactured by: Dexcel Pharma Technologies Ltd. 10 Hakidma Street, Yokneam, 20692, Israel"],"storage_and_handling":["STORAGE AND HANDLING read the directions, warnings, and package insert before use keep the carton and package insert. They contain important information. store at 20-25°C (68-77°F) keep product out of high heat and humidity protect product from moisture"],"version":"2","warnings":["WARNINGS Allergy alert: Do not use if you are allergic to omeprazole if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. had heartburn over 3 months. This may be a sign of a more serious condition. 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 frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain taking warfarin, clopidogrel or cilostazol (blood-thinning medicines) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) prescription antiretrovirals (medicines for HIV infection) 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 ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"]}