Label: OMESEC- omeprazole capsule, delayed release
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Contains inactivated NDC Code(s)
NDC Code(s): 16853-1308-1, 16853-1308-2, 16853-1308-3, 16853-1308-4 - Packager: Corporacion Infarmasa
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 28, 2010
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- Official Label (Printer Friendly)
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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
- ASK DOCTOR/PHARMACIST
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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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
- PURPOSE
- QUESTIONS
- STORAGE AND HANDLING
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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
- 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
Other Information
- Read the directions, warnings and package insert before use
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OMESEC
omeprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16853-1308 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (Omeprazole - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength 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 Color red (Red Capsule) Score score with uneven pieces Shape CAPSULE (Delayed Release Capsules) Size 17mm Flavor Imprint Code None Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16853-1308-2 28 in 1 BLISTER PACK 2 NDC:16853-1308-1 14 in 1 BLISTER PACK 3 NDC:16853-1308-3 42 in 1 BLISTER PACK 4 NDC:16853-1308-4 2 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075410 02/28/2010 Labeler - Corporacion Infarmasa (934098294) Establishment Name Address ID/FEI Business Operations Corporacion Infarmasa 934098294 manufacture