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| Product NDC Code | 69618-073 | ||||
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| Drug Name | Esomeprazole magnesium |
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| Type | Generic | ||||
| Pharm Class | Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, DELAYED RELEASE | ||||
| RxCUI drug identifier | 606726 | ||||
| Application Number | ANDA216349 | ||||
| Labeler Name | Reliable 1 Laboratories LLC | ||||
| Packages |
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Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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 Repeated 14-Day Courses (if needed) 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 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). Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg: FD&C Blue 2, Gelatin, Hydroxypropyl Cellulose, Hypromellose, 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 1-516-314-0666 Contact Reliable 1 Laboratories LLC or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Made in India Additional Information KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION. Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PORTECTION" 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. Marketed by: Graviti Pharmaceuticals Inc., Wilmington, Delaware-19801, USA. Made in India
Spl product data elements
Usually a list of ingredients in a drug product.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 20mg;223
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Principal Display Panel - 20 mg Capsules: Container Label Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg 24 HR Acid Reducer Treats Frequent Heartburn May take 1 to 4 Days for Full effect 14 Capsules One 14-day Course of Treatment Distributed by: Reliable-1 Laboratories LLC Principal Display Panel - 20 mg Capsules: Carton Label NDC 69618-073-42 Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg 24 HR Acid Reducer Treats Frequent Heartburn May take 1 to 4 Days for Full effect 14 Capsules Three 14-day Courses of Treatment Distributed by: Reliable-1 Laboratories LLC image image
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API