FDA Label for Esomeprazole Magnesium
View Indications, Usage & Precautions
Esomeprazole Magnesium Product Label
The following document was submitted to the FDA by the labeler of this product Rising Pharma Holdings, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
| 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
- 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
- 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
- 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
- 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
- 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.
- read the directions and warnings before use
- keep the carton. It contains important information.
- Store at 20° to 25°C (68° to 77°F).
- Treats Frequent 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
Warnings
Allergy alert
Do not use if you are allergic to esomeprazole
Do not use if you have
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have
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
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
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
Other Information
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 1-855-298-4506
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
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
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.
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