{"active_ingredient":["ACTIVE INGREDIENT(S) Active ingredient (in each tablet) Omeprazole, USP 20 mg (equivalent to 20.6 mg omeprazole magnesium)"],"ask_doctor":["ASK A DOCTOR BEFORE USE IF 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 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 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 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":"20250811","id":"dcf79426-6aec-432a-aabe-dcb98c0f2cec","inactive_ingredient":["INACTIVE INGREDIENTS Inactive ingredients colloidal silicone dioxide, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, red iron oxide, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate"],"indications_and_usage":["USE(S) Uses • 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 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":["ANDA218829"],"brand_name":["Omeprazole 20 mg"],"generic_name":["OMEPRAZOLE 20 MG"],"is_original_packager":[true],"manufacturer_name":["MARKSANS PHARMA LIMITED"],"package_ndc":["25000-091-77","25000-091-76"],"product_ndc":["25000-091"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["402014"],"spl_id":["dcf79426-6aec-432a-aabe-dcb98c0f2cec"],"spl_set_id":["921bf750-9dd7-42ff-82bb-043b03f0fe69"],"substance_name":["OMEPRAZOLE MAGNESIUM"],"unii":["426QFE7XLK"],"upc":["0325000091767","0325000091774"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC: 25000-091-76 Omeprazole Delayed-Release Tablets 20 mg 14's count Carton NDC: 25000-091-76 Omeprazole Delayed-Release Tablets 20 mg 14's count Label NDC: 25000-091-77 Omeprazole Delayed-Release Tablets 20 mg 14's count (2 x 7's blister) Carton omeprazole-14s-blister-carton omeprazole-14s-bottle-pack-label omeprazole-14s-blisterpack-carton"],"pregnancy_or_breast_feeding":["PREGNANCY/BREASTFEEDING If pregnant or breast-feeding, ask a health professional before use."],"purpose":["PURPOSE Purpose Acid reducer"],"set_id":"921bf750-9dd7-42ff-82bb-043b03f0fe69","spl_product_data_elements":["Omeprazole 20 mg Omeprazole 20 mg OMEPRAZOLE MAGNESIUM OMEPRAZOLE GLYCERYL MONOSTEARATE SILICON DIOXIDE CROSPOVIDONE, UNSPECIFIED HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 6000 POLYSORBATE 80 FERRIC OXIDE RED DIMETHICONE SODIUM STEARYL FUMARATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE 91"],"spl_unclassified_section":["QUESTIONS OR COMMENTS Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM) Tips for Managing Heartburn • 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 do not eat big meals. • If overweight, lose weight. • Quit smoking. Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate Verna, Goa-403722, India"],"stop_use":["STOP USE AND ASK DOCTOR IF 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":["STORAGE Other information read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F) and protect from moisture"],"version":"3","warnings":["WARNINGS Warnings Allergy alert: Do not use if you are allergic to Omeprazole Omeprazole may cause severe skin reactions. Symptoms include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical attention right away."]}