FDA Label for Omesec
View Indications, Usage & Precautions
Omesec Product Label
The following document was submitted to the FDA by the labeler of this product Corporacion Infarmasa. 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.
Otc - Ask Doctor
Ask a doctor before use if you have: * Had heartburn over 3 months. This may be a sign of a more serious condition. * 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. * Frequent wheezing, particularly with heartburn * Unexplained weight loss * Nausea or vomiting * Stomach pain
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking:
- Warfarin (blood-thinning medicine)
- Prescription antifungal or anti-yeast medicines
- Diazepam (anxiety medicine)
- Digoxin (heart medicine)
- Tacrolimus (immune system medicine)
- Atazanavir (medicine for HIV infection)
Otc - Do Not Use
Allergy Alert: Do not use if you are allergic to Omeprazole
Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.
These may be signs of a serious condition. See your doctor.
Otc - 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)
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Stop use and ask a Doctor if:
* Your heartburn continues or worsens
* You need to take his product for more than 14 days
* You need to take more than 1 course of treatment every 4 months
Do not use if capsule blister unit is open or torn
Otc - Purpose
UseTreats 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.
Otc - Questions
If you have questions of a medical nature, please contact your pharmacist, doctor or health care proffesional
Storage And Handling
- Read the directions, warnings and package insert before use
- Keep the carton and package insert. They contain important information
- Store at 20°C to 25°C ( 68°F to 77°F)
- Keep product out of high heat and humidity
- Protect product from moisture
Dosage & Administration
Adults 18 years of age and older: This product is to be used once a day (every 24 hours), every day for 14 days. It may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
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
- Do not chew or crush the capsule
- Do not crush capsules in food
- 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 more than 14 days or more often than every 4 month unless directed by a doctor Children under 18 years of age: ask a doctor
- Read the directions, warnings and package insert before use
Other Information
Inactive Ingredient
Diethyl Phthalate, Sodium Lauryl Sulfate, Disodium Phosphate, Hydroxypropyl Cellulose, Lactose, Hypromellose, Corn Starch, Hypromellose Phthalate, Sucrose
Package Label.Principal Display Panel
Omesec Caps
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