OMESEC

Dosage form: capsule, delayed release
Ingredients: OMEPRAZOLE 20mg
Labeler: Corporacion Infarmasa
NDC Code: 16853-1308

Drug Facts


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


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)

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


In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)



If pregnant or breast-feeding, ask a health professional before 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


Use

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.


If you have questions of a medical nature, please contact your pharmacist, doctor or health care proffesional


  • Read the directions, warnings and package insert before use
  • Keep the carton and package insert. They contain important information
  • Store at 20ºC to 25ºC ( 68ºF to 77ºF)
  • Keep product out of high heat and humidity
  • Protect product from moisture

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

Diethyl Phthalate, Sodium Lauryl Sulfate, Disodium Phosphate, Hydroxypropyl Cellulose, Lactose, Hypromellose, Corn Starch, Hypromellose Phthalate, Sucrose

Omesec Caps
OMESEC 
omeprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16853-1308
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (Omeprazole) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
DIETHYL PHTHALATE0.144 mg
SODIUM LAURYL SULFATE0.432 mg
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE0.816 mg
HYDROXYPROPYL CELLULOSE6.24 mg
LACTOSE8.16 mg
HYPROMELLOSE11.81 mg
STARCH, CORN24.96 mg
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)25.18 mg
SUCROSE142.26 mg
Product Characteristics
Colorred (Red Capsule) Scorescore with uneven pieces
ShapeCAPSULE (Delayed Release Capsules) Size17mm
FlavorImprint CodeNone
Contains    
Packaging
#Item CodePackage Description
1NDC:16853-1308-228 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BLISTER PACK
2NDC:16853-1308-114 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BLISTER PACK
3NDC:16853-1308-342 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BLISTER PACK
4NDC:16853-1308-42 CAPSULE, DELAYED RELEASE (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07541002/28/2010
Labeler - Corporacion Infarmasa (934098294)
Establishment
NameAddressID/FEIOperations
Corporacion Infarmasa934098294manufacture

Revised: 02/2010
 
Corporacion Infarmasa

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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