Drug Facts
Composition & Profile
Identifiers & Packaging
Package/Label Principal Display Panel Principal Display Panel - 20 mg Capsules: Container Label NDC 72657-127-14 Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect 24 HOURS 14 Capsules One 14-day course of treatment Product of India label; Package/Label Principal Display Panel Principal Display Panel - 42 Capsules Carton label NDC 73657-127-42 Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect 24 HOURS 42 Capsules Three 14-day courses of treatment Product of India carton
- Package/Label Principal Display Panel Principal Display Panel - 20 mg Capsules: Container Label NDC 72657-127-14 Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect 24 HOURS 14 Capsules One 14-day course of treatment Product of India label
- Package/Label Principal Display Panel Principal Display Panel - 42 Capsules Carton label NDC 73657-127-42 Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect 24 HOURS 42 Capsules Three 14-day courses of treatment Product of India carton
Overview
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
Indications & Usage
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
Dosage & Administration
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). Questions or comments? Call toll-free weekdays 9 AM to 6 PM EST at 1-888-721-7115. Product of India Additional 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. Distributed by: Glenmark Therapeutics Inc., USA Elmwood Park, NJ 07407 Product of India 07/25
Warnings & Precautions
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.
Purpose
Purpose Acid reducer
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.
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