OMESEC

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

OTC - ASK DOCTOR SECTION

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 SECTION

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 SECTION

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 SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - STOP USE SECTION

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 SECTION

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.

OTC - QUESTIONS SECTION

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

STORAGE AND HANDLING SECTION

• 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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Omesec Caps

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

• OMESEC
• Omeprazole
• DIETHYL PHTHALATE
• SODIUM LAURYL SULFATE
• SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
• HYDROXYPROPYL CELLULOSE
• LACTOSE
• HYPROMELLOSE
• STARCH, CORN
• HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
• SUCROSE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 229 matching rows.

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.