{"active_ingredient":["Active ingredient (in each capsule) Omeprazole delayed-release capsules, USP 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)"],"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"],"effective_time":"20240219","id":"0c2600f3-e9de-4e73-8ee1-9aeb94d228e4","inactive_ingredient":["Inactive ingredients black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, hypromellose, iron oxide red, macrogol, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, mono and di-glycerides, polysorbate 80, polyvinyl alcohol-part. hydrolyzed, potassium hydroxide, shellac, sodium lauryl sulphate, sugar spheres [liquid glucose, starch (maize), sucrose], talc, titanium dioxide, triethyl citrate."],"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":["ANDA213201"],"brand_name":["Omeprazole"],"generic_name":["OMEPRAZOLE"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"package_ndc":["58602-837-05"],"product_ndc":["58602-837"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198051"],"spl_id":["0c2600f3-e9de-4e73-8ee1-9aeb94d228e4"],"spl_set_id":["19097902-a5e6-423a-8569-31c569cd3cdb"],"substance_name":["OMEPRAZOLE MAGNESIUM"],"unii":["426QFE7XLK"],"upc":["0358602837051"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Bottle) AUROHEALTH NDC 58602-837-05 See current Drug Facts Omeprazole Delayed-Release Capsules, USP 20 mg/Acid Reducer Treats Frequent Heartburn! 24 HR 14 Capsules One 14-Day Course of Treatment May take 1 to 4 days for full effect PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label AUROHEALTH NDC 58602-837-05 See current Drug Facts *Compare to the active ingredient in Prilosec OTC ® Omeprazole Delayed-Release Capsules, USP 20 mg/Acid Reducer Treats Frequent Heartburn ! 24 HR OZM 20 14 Capsules One 14-Day Course of Treatment May Take 1 to 4 days for full effect PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label"],"purpose":["Purpose Acid reducer"],"set_id":"19097902-a5e6-423a-8569-31c569cd3cdb","spl_product_data_elements":["Omeprazole Omeprazole OMEPRAZOLE MAGNESIUM OMEPRAZOLE FERROSOFERRIC OXIDE SILICON DIOXIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE GELATIN, UNSPECIFIED HYPROMELLOSE 2910 (3 MPA.S) FERRIC OXIDE RED POLYETHYLENE GLYCOL 3350 MAGNESIUM OXIDE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) MICROCRYSTALLINE CELLULOSE 102 GLYCERYL MONO AND DIPALMITOSTEARATE POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED POTASSIUM HYDROXIDE SHELLAC SODIUM LAURYL SULFATE DEXTROSE, UNSPECIFIED FORM STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE light pinkish red cap White to off white body OZM;20"],"spl_unclassified_section":["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 do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush capsules.","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.","Other information each capsule contains: calcium 110 mg 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 FDA approved dissolution test specifications differ from USP.","Questions? Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)","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 avoid big meals If overweight, lose weight Quit smoking Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009"],"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":"2","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.","If pregnant or breast-feeding, ask a health professional before use."]}