{"active_ingredient":["Active ingredients (in each capsule) Omeprazole, USP ……………………………………….20 mg Sodium Bicarbonate, USP …………………………....1100 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. 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 a sodium-restricted diet"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking 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 bloody or black stools These may be signs of a serious condition. See your doctor."],"dosage_and_administration":["14 Day Course of Treatment swallow 1 capsule with a glass of water at least 1 hour before eating in the morning take every day for 14 days do not take more than 1 capsule a day do not chew or crush the capsule do not open capsule and sprinkle on 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":"20250825","id":"f896c72c-b1d3-4e29-a646-9d6fe9dfc49b","inactive_ingredient":["Inactive ingredient croscarmellose sodium, FD&C blue # 1, gelatin, magnesium stearate, polysorbate 80, sodium lauryl sulfate and titanium dioxide. The capsule shell is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."],"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 at 1-800-222-1222."],"openfda":{},"package_label_principal_display_panel":["Carton and container labels NDC 70771-1337-7 Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg 14 Capsules Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg"],"purpose":["Purpose Omeprazole, USP .............................................................................Acid reducer Sodium Bicarbonate, USP ………Allows absorption of this omeprazole product"],"set_id":"782e6f84-b9b6-4c3d-96a0-8a267a81b3de","spl_product_data_elements":["omeprazole and sodium bicarbonate omeprazole and sodium bicarbonate OMEPRAZOLE OMEPRAZOLE SODIUM BICARBONATE BICARBONATE ION CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 GELATIN MAGNESIUM STEARATE POLYSORBATE 80 SODIUM LAURYL SULFATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL WATER SHELLAC AMMONIA OPAQUE WHITE OPAQUE WHITE CAPSULE 503"],"spl_unclassified_section":["Drug Facts","If pregnant or breastfeeding, ask a health professional before use.","Other information each capsule contains: sodium 301.34 mg read the directions, warnings and accompanying label information before use store at 20 ○ to 25 ○ C (68 ○ to 77 ○ F) tamper-evident: do not use if the blue band around the capsule is missing or broken. Do not use if foil inner seal imprinted with \"Sealed for your protection\" is missing, open or broken. keep product out of high heat and humidity protect product from moisture","Questions or comments? Serious side effects associated with use of this drug product may be reported to this number: 1-877-993-8779 or visit www.zydususa.com Hours of operation: 9:00 am to 5:00 pm EST M-F. You may report side effects to FDA at 1-800-FDA-1088. How Omeprazole and Sodium Bicarbonate Capsule Works For Your Frequent Heartburn Omeprazole and sodium bicarbonate capsule works differently from other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and sodium bicarbonate capsule stops acid production at the source – the acid pump that produces stomach acid. Omeprazole and sodium bicarbonate capsule is to be used once a day (every 24 hours), every day for 14 days. What to Expect When Using Omeprazole and Sodium Bicarbonate Capsule Omeprazole and sodium bicarbonate capsule is a different type of medicine from antacids and other acid reducers. Omeprazole and sodium bicarbonate capsule 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. 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 and Sodium Bicarbonate Capsules Sold Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg are white to off-white fine powder filled in hard gelatin capsule shells of size '00' having an opaque white cap and an opaque white body printed with '503' on body in black ink and a blue tamper evident band and are available as follows: NDC 68382-503-67 in one HDPE bottle of 14 capsules NDC 68382-503-17 in two HDPE bottles of 28 capsules (one bottle contains 14 capsules) NDC 68382-503-04 in three HDPE bottles of 42 capsules (one bottle contains 14 capsules) 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.","Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Rev.: 02/19"],"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"],"version":"8","warnings":["Warnings Allergy alert: Do not use if you are allergic to omeprazole"],"when_using":["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, although some people get complete relief of symptoms within 24 hours"]}