ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release
LITTLE PHARMA, INC.
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Drug Facts
Active ingredient (in each capsule)
*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)
Uses
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- treats frequent heartburn (occurs 2 or more days a week)
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- 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:
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- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
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- heartburn with lightheadedness, sweating or dizziness
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- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
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- frequent chest pain
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have:
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- had heartburn over 3 months. This may be a sign of a more serious condition.
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- frequent wheezing, particularly with heartburn
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- unexplained weight loss
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- nausea or vomiting
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- stomach pain
Ask doctor/pharmacist before use if you are
- •
- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Directions
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- adults 18 years of age and older
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- this product is to be used once a day (every 24 hours), every day for 14 days
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- may take 1 to 4 days for full effect
14-Day Course of Treatment
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- swallow 1 capsule with a glass of water before eating in the morning
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- take every day for 14 days
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- do not take more than 1 capsule a day
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- swallow whole. Do not crush or chew capsules.
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- do not use for more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
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- you may repeat a 14-day course every 4 months
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- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
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- children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
Other Information
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- read the directions and warnings before use
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- Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room temperature.]
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- keep the carton. It contains important information.
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- TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around center of each capsule is broken or missing.
Inactive Ingredients
FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.
Distributed by:
Little Pharma Inc.
New York, NY 10023
| ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed release |
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| Labeler - LITTLE PHARMA, INC. (074328189) |
| Registrant - LITTLE PHARMA, INC. (074328189) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories Inc. | 184769029 | MANUFACTURE(72559-011) | |
Revised: 3/2021
Document Id: e45621ea-cc15-4a8e-98d2-d10ab424a45e
Set id: e45621ea-cc15-4a8e-98d2-d10ab424a45e
Version: 1
Effective Time: 20210323
LITTLE PHARMA, INC.