Omeprazole Tablet, Delayed Release
FDA Label NDC 83324-011

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Omeprazole (NDC 83324-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, use, warnings, do not use if you have:, ask a doctor before use if you have:, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Tablet)

→ Purpose

→ Use

→ Warnings

→ Do Not Use If You Have:

→ Ask A Doctor Before Use If You Have:

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ Stop Use And Ask A Doctor If:

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

Active Ingredient (In Each Tablet)

Omeprazole delayed-release tablet, 20 mg
(equivalent to 20.6 mg omeprazole magnesium USP)

Purpose

Acid reducer

Use

• treats frequent heartburn (occurs 2 or moredays a week)
• not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Allergy alert:

Do not use if you are allergic to omeprazole.
Omeprazole may cause severe skin reactions. Symptoms may include:
• skin reddening • blisters • rash
If an allergy reaction occurs, stop use and seek medical help right away.

Do Not Use If You Have:

• trouble or pain swallowing food, vomiting with blood, or bloody or black stools
• 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
These may be signs of a serious condition. See your doctor.

Ask A Doctor Before Use If You Have:

• had heartburn over 3 months. This may be a sign of a more serious condition.
• frequent wheezing, particularly with heartburn
• unexplained weight loss • nausea or vomiting
• stomach pain

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug.
Acid reducers may interact with certain prescription drugs.

Stop Use And Ask A Doctor If:

• your heartburn continues or worsens
• you need to take this product for more than 14 days
• you need to take more than 1 course of treatment every 4 months
• you get diarrhea
• you develop a rash or joint pain

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• for 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; some people get complete relief of symptoms within 24 hours
14-Day Course of Treatment
• swallow 1 tablet with a glass of water before eating in the morning
• take every day for 14 days
• do not take more than 1 tablet a day
• do not use for more than 14 days unless directed by your doctor
• swallow whole. Do not chew or crush tablets.
Repeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months
• do not take for more than 14 days or more often than every 4 months unless directed by a doctor
• children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Other Information

• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20° to 25° C (68° to 77° F) and protect from moisture

Inactive Ingredients

colloidal silicon dioxide, crospovidone, glyceryl monostearate, hypromellose, hydroxypropyl cellulose, iron oxide red, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium hydroxide, sodium lauryl sulphate, starlac (contains lactose monohydrate and corn starch), sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.