Esomeprazole Magnesium Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE ESOMEPRAZOLE SILICON DIOXIDE FD&C BLUE NO. 1 GELATIN, UNSPECIFIED HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM CARBONATE MAGNESIUM OXIDE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A GLYCERYL MONOSTEARATE POLYSORBATE 80 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE AMMONIA DEXTROSE, UNSPECIFIED FORM STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FERRIC OXIDE YELLOW I81
Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label) Sunmark ® NDC 70677-0069-1 24 hour Acid Reducer Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg* Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect 14 Capsules One 14-day course of treatment esomeprazole-fig1; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton) Sunmark ® #Compare to Nexium ® 24 HR Active ingredient NDC 70677-0069-01 See new warning 24 hour Acid Reducer Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg* Treats Frequent Heartburn May take 1 to 4 days for full effect Acid Reducer 14 Capsules One 14-day Course of treatment fig-2
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label) Sunmark ® NDC 70677-0069-1 24 hour Acid Reducer Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg* Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect 14 Capsules One 14-day course of treatment esomeprazole-fig1
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton) Sunmark ® #Compare to Nexium ® 24 HR Active ingredient NDC 70677-0069-01 See new warning 24 hour Acid Reducer Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg* Treats Frequent Heartburn May take 1 to 4 days for full effect Acid Reducer 14 Capsules One 14-day Course of treatment fig-2
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 20-25°C (68-77°F) Meets USP dissolution test 2
Warnings & Precautions
Warnings Allergy alert: Do not use if you are allergic to esomeprazole
Purpose
Purpose Acid reducer
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.
Stop Use & Ask a Doctor
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
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)
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