OMESEC - omeprazole capsule, delayed release 
Corporacion Infarmasa

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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:

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


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

Repeated 14-Day Courses (if needed)

Children under 18 years of age: ask a doctor

Other Information

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

Omesec Caps
Carton Label
OMESEC 
omeprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16853-1308
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (Omeprazole - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
DIETHYL PHTHALATE (UNII: UF064M00AF) 0.144 mg
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 0.432 mg
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) 0.816 mg
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) 6.24 mg
LACTOSE (UNII: J2B2A4N98G) 8.16 mg
HYPROMELLOSE (UNII: 3NXW29V3WO) 11.81 mg
STARCH, CORN (UNII: O8232NY3SJ) 24.96 mg
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5) 25.18 mg
SUCROSE (UNII: C151H8M554) 142.26 mg
Product Characteristics
Colorred (Red Capsule) Scorescore with uneven pieces
ShapeCAPSULE (Delayed Release Capsules) Size17mm
FlavorImprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16853-1308-228 in 1 BLISTER PACK
2NDC:16853-1308-114 in 1 BLISTER PACK
3NDC:16853-1308-342 in 1 BLISTER PACK
4NDC:16853-1308-42 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/FEIBusiness Operations
Corporacion Infarmasa934098294manufacture

Revised: 2/2010
Document Id: b16d55b9-70a2-4734-a8f4-bfd1cd108be4
Set id: 9217efc8-ec38-45e1-8319-32a6303cc050
Version: 3
Effective Time: 20100228
 
Corporacion Infarmasa