Label: OMEPRAZOLE tablet, delayed release

  • NDC Code(s): 69168-476-14, 69168-476-15, 69168-476-42, 69168-476-61
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 19, 2025

If you are a consumer or patient please visit this version.

  • Active ingredient(s)
    Omeprazole Delayed-Release Tablet, 20 mg - (equivalent to 20.6 mg omeprazole magnesium USP)
  • Purpose
    Acid reducer
  • Use(s)
    • 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 allergy reaction ...
  • 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 ...
  • 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 ...
  • Questions/Comments
    Call 1-888-952-0050 - (Monday-Friday 9 AM – 5 PM EST
  • Principal Display Panel
    Omeprazole label - Omeprazole carton
  • INGREDIENTS AND APPEARANCE
    Product Information