{"active_ingredient":["Active ingredient(in each tablet) Omeprazole USP 20 mg"],"ask_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_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs."],"do_not_use":["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."],"dosage_and_administration":["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."],"effective_time":"20230814","id":"252eeb77-6319-49df-9259-fcf2f917b2b5","inactive_ingredient":["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."],"indications_and_usage":["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"],"keep_out_of_reach_of_children":["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)."],"openfda":{"application_number":["ANDA207891"],"brand_name":["Omeprazole"],"generic_name":["OMEPRAZOLE"],"is_original_packager":[true],"manufacturer_name":["STRATEGIC SOURCING SERVICES LLC"],"nui":["N0000175525","N0000000147","N0000182140"],"package_ndc":["70677-1098-1"],"pharm_class_epc":["Proton Pump Inhibitor [EPC]"],"pharm_class_moa":["Proton Pump Inhibitors [MoA]","Cytochrome P450 2C19 Inhibitors [MoA]"],"product_ndc":["70677-1098"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["402014"],"spl_id":["252eeb77-6319-49df-9259-fcf2f917b2b5"],"spl_set_id":["56380ccc-6fc2-4e1b-bd87-da24c9aa31cd"],"substance_name":["OMEPRAZOLE"],"unii":["KG60484QX9"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton NDC 70677-1098-1 *COMPARE TO PRILOSEC OTC ® Foster & Thrive™ Omeprazole Delayed-Release Tablets 20 mg / ACID REDUCER SWALLOW- DO NOT CHEW 24 HR Treats FREQUENT Heartburn! One 14-day course of treatment May take 1 to 4 days for full effect SEE NEW WARNING INFORMATION ACTUAL SIZE 14 TABLETS PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Acid reducer"],"questions":["Questions or Comments? Call 833-358-6431 M - F, 9AM - 7PM EST"],"set_id":"56380ccc-6fc2-4e1b-bd87-da24c9aa31cd","spl_product_data_elements":["Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ANHYDROUS LACTOSE HYPROMELLOSE, UNSPECIFIED HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/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"],"spl_unclassified_section":["Drug Facts","Distributed by: McKesson Corp., via Strategic Sourcing Services LLC. Memphis, TN 38141"],"stop_use":["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"],"storage_and_handling":["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"],"version":"1","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 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)."]}