{"active_ingredient":[""],"description":["Esomeprazole Magnesium Drug Facts Drug Facts Active ingredient (in each capsule) Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate) Purpose Acid reducer 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 Warnings Allergy alert: Do not use if you are allergic to esomeprazole. Esomeprazole 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. Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect 14-Day Course of Treatment swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. 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 before use. Heartburn in children may sometimes be caused by a serious condition. 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). Inactive Ingredients FD&C Blue 2, gelatin, hypromellose, hydroxypropyl Cellulose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, pharmaceutical ink, polysorbate 80, sugar spheres, talc, triethyl citrate. Questions or comments? Call toll-free weekdays 9 AM to 5 PM EST at 1-833-210-9017 Additional Information KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION. Do Not Use if seal under bottle cap imprinted with \"SEALED for YOUR PROTECTION\" or Blue band around the center of each capsule is broken or missing. Tips for Managing Heartburn Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables. Eat slowly and do not eat big meals. Do not eat late at night or just before bedtime. Do not lie flat or bend over soon after eating. Raise the head of your bed. Wear loose-fitting clothing around your stomach. If you are overweight, lose weight. If you smoke, quit smoking. Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana-502307, INDIA. Manufactured for: Graviti Pharmaceuticals, Inc., Wilmington, Delaware-19801, USA. M.L. No.: 12/SRD/TS/2017/F/G Revised: 10/2024"],"dosage_and_administration":[""],"effective_time":"20260624","id":"9b14bf68-e08d-42ad-a622-d41698904a82","inactive_ingredient":[""],"indications_and_usage":[""],"keep_out_of_reach_of_children":[""],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Principal Display Panel - 20 mg Capsules: Container Label Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg Acid Reducer Treats Frequent Heartburn May take 1 to 4 Days for Full effect 24 HR 14 Capsules One 14-day Course of Treatment Manufactured for Graviti Pharmaceuticals Inc. image","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Principal Display Panel - 14 Capsule Carton label NDC 69844-115-01 Compare to the active ingredient in Nexium ® 24HR\" Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg Acid Reducer Treats Frequent Heartburn May take 1 to 4 Days for Full effect 24 HR 14 Capsules One 14-day Course of Treatment See New Warning Information Manufactured for Graviti Pharmaceuticals Inc. image"],"purpose":[""],"set_id":"05c93df5-f142-4fdb-8e3d-54490c035ca9","spl_product_data_elements":["esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE RAW SUGAR HYPROMELLOSE 2910 (5 MPA.S) POLYSORBATE 80 HYDROXYPROPYL CELLULOSE, UNSPECIFIED TALC MAGNESIUM STEARATE METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A TRIETHYL CITRATE GELATIN, UNSPECIFIED FD&C BLUE NO. 2 GLYCERYL MONOSTEARATE GLYCERYL DISTEARATE white opaque colored 186;20mg"],"version":"2","warnings":[""]}