OMESEC- omeprazole capsule, delayed release

OMESEC by

Drug Labeling and Warnings

OMESEC by is a Otc medication manufactured, distributed, or labeled by Corporacion Infarmasa. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)

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

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)

PREGNANCY OR BREAST FEEDING

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

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

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.

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 20ºC to 25ºC ( 68ºF to 77ºF)
  
• 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

PRINCIPAL DISPLAY PANEL

Omesec Caps

INGREDIENTS AND APPEARANCE

OMESEC 
omeprazole capsule, delayed release

Product 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