Label: OMEPRAZOLE tablet, delayed release

  • NDC Code(s): 59726-298-14
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 2, 2025

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  • Active ingredient (in each tablet)
    Omeprazole delayed-release tablet 20 mg - (equivalent to 20.6 mg omeprazole magnesium)
  • Purpose
    Acid reducer
  • 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
  • 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 allergic reaction ...
  • 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 ...
  • 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    Ÿ nausea or vomiting   stomach ...
  • 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 ...
  • 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 (1-800-222-1222) 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 ...
  • 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
    acetyl tributyl citrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type C ...
  • Tips for Managing Heartburn
    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 ...
  • Principal display panel
    Compare to the active ingredient in Prilosec® OTC† 24-hour - Omeprazole - Delayed-release tablets 20 mg - Acid reducer - Treats FREQUENT heartburn ! May take 1 to 4 days for full effect - Tablets - One ...
  • Package label
    Omeprazole delayed release tablets 20 mg
  • INGREDIENTS AND APPEARANCE
    Product Information