ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM RISING PHARMA HOLDINGS, INC. FDA Approved Active ingredient (in each capsule) Purpose Esomeprazole 20 mg Acid reducer (Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate) 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. 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). 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 1-844-474-7464. Contact Graviti Pharmaceuticals Inc., or www.gravitipharma.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Made in India See new warning information Treats Frequent Heartburn Esomeprazole magnesium delayed-release capsules 20 mg/acid reducer May take 1 to 4 days for full effect 14 CAPSULES One 14-day course of treatment Capsules 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
FunFoxMeds bottle
Route
ORAL
Applications
ANDA216349

Drug Facts

Composition & Profile

Quantities
14 capsules 42 capsules
Treats Conditions
Active Ingredient In Each Capsule Purpose Esomeprazole 20 Mg Acid Reducer Each Delayed Release Capsule Corresponds To 22 250 Mg Esomeprazole Magnesium Trihydrate 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 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 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 1 844 474 7464 Contact Graviti Pharmaceuticals Inc Or Www Gravitipharma Com Or Fda At 1 800 Fda 1088 Or Www Fda Gov Medwatch Made In India See New Warning Information Treats Frequent Heartburn Esomeprazole Magnesium Delayed Release Capsules 20 Mg Acid Reducer May Take 1 To 4 Days For Full Effect 14 Capsules One 14 Day Course Of Treatment Capsules 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
Pill Appearance
Shape: capsule Color: white Imprint: 20mg;223

Identifiers & Packaging

Container Type BOTTLE
UNII
R6DXU4WAY9
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Principal Display Panel - 20 mg Capsules: Container Label NDC 16571-880-41 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: Rising Pharma Holdings, Inc. Principal Display Panel - 20 mg Capsules: Carton Label NDC 16571-880-41 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: Rising Pharma Holdings, Inc. Principal Display Panel - 20 mg Capsules: Carton Label NDC 16571-880-42 Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg 24 HR Acid Reducer Treats Frequent Heartburn May take 1 to 4 Days for Full effect 42 Capsules Three 14-day Courses of Treatment Distributed by: Rising Pharma Holdings, Inc. image image image

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Principal Display Panel - 20 mg Capsules: Container Label NDC 16571-880-41 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: Rising Pharma Holdings, Inc. Principal Display Panel - 20 mg Capsules: Carton Label NDC 16571-880-41 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: Rising Pharma Holdings, Inc. Principal Display Panel - 20 mg Capsules: Carton Label NDC 16571-880-42 Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg 24 HR Acid Reducer Treats Frequent Heartburn May take 1 to 4 Days for Full effect 42 Capsules Three 14-day Courses of Treatment Distributed by: Rising Pharma Holdings, Inc. image image image

Overview

Active ingredient (in each capsule) Purpose Esomeprazole 20 mg Acid reducer (Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate) 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. 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). 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 1-844-474-7464. Contact Graviti Pharmaceuticals Inc., or www.gravitipharma.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Made in India See new warning information Treats Frequent Heartburn Esomeprazole magnesium delayed-release capsules 20 mg/acid reducer May take 1 to 4 days for full effect 14 CAPSULES One 14-day course of treatment Capsules 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

Dosage & Administration

Not available

Warnings & Precautions
No warnings available yet.

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