Omesec
FDA Label NDC 16853-1308

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Corporacion Infarmasa for the product Omesec (NDC 16853-1308). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - ask doctor, otc - ask doctor/pharmacist, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, otc - stop use, otc - purpose, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Do not use if capsule blister unit is open or torn

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

      Other Information
      • Read the directions, warnings and package insert before use

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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