Country: United States
Language: English
Source: NLM (National Library of Medicine)
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT)
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ORAL
OTC DRUG
Acid reducer - 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 - 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. - 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 - taking a prescription drug. Acid reducers may interact with certain prescription drugs. - 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 o
Abbreviated New Drug Application
ESOMEPRAZOLE MAGNESIUM - ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PUBLIX ---------- ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES USP 20 MG _DRUG FACTS_ _ACTIVE INGREDIENT (IN EACH CAPSULE)_ Esomeprazole 20 mg (Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP) _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 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 (1- 800-222-1222). _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 w Read the complete document