Omeprazole Tablet, Delayed Release
FDA Label NDC 63548-4080

Omeprazole delayed-release tablet 20 mg

(equivalent to 20.6 mg omeprazole magnesium)     

Acid reducer

• 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

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 allergic reaction occurs, stop use and seek medical help right away.

• 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.

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

taking a prescription drug.

Acid reducers may interact with certain prescription drugs.

• 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

ask a health professional before use.

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

• 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 everyday 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.

• 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

acetyl tributyl citrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, polyvinyl alcohol, sucrose, talc, titanium dioxide, triethyl citrate

• Do not lie flat or bend over after eating
• Do not wear tight-fitting clothing around the stomach
• Do not eat before bedtime
• Raise the head of your bed
• Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
• Eat slowly and avoid big meals
• If overweight, lose weight
• Quit smoking

†Compare to the active ingredient in Prilosec® OTC

24-hour

Omeprazole

Delayed-release tablets 20 mg

Acid reducer

Treats FREQUENT heartburn 24 HR

May take 1 to 4 days for full effect

Tablets

Coated with Wildberry Flavor

†This product is not affiliated with, manufactured by or produced by the makers or owners of Prilosec OTC®.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OR TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172