Label: OMEPRAZOLE 20 MG tablet, delayed release

  • NDC Code(s): 25000-091-76, 25000-091-77
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 11, 2025

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

  • ACTIVE INGREDIENT(S)

    Active ingredient (in each tablet)                                         
    Omeprazole, USP 20 mg 
    (equivalent to 20.6 mg omeprazole magnesium)


  • PURPOSE

    Purpose 
    Acid reducer



  • USE(S)

    Uses
    • 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

    Warnings
    Allergy alert: 

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

  • DO NOT USE

    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

    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

    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 DOCTOR IF

    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



  • PREGNANCY/BREASTFEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    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.
  • STORAGE

    Other information

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

  • INACTIVE INGREDIENTS

    Inactive ingredients 
    colloidal silicone dioxide, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, red iron oxide, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate



  • QUESTIONS OR COMMENTS

    Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)

    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, spicy, fatty or fried foods, chocolate, caffeine,     alcohol and certain fruits and vegetables.      
    • Eat slowly and do not eat big meals.
    • If overweight, lose weight. 
    • Quit smoking. 

    Manufactured for:
    Time-Cap Labs, Inc. 
    7 Michael Avenue, 
    Farmingdale, 
    NY 11735, USA

    Manufactured by: 
    Marksans Pharma Ltd.
    Plot No. L-82, L-83
    Verna Indl. Estate
    Verna, Goa-403722, India  



  • PRINCIPAL DISPLAY PANEL

    NDC: 25000-091-76
    Omeprazole Delayed-Release Tablets 20 mg 
    14's count Carton 


    omeprazole-14s-blister-carton


    NDC: 25000-091-76
    Omeprazole Delayed-Release Tablets 20 mg 
    14's count Label 


    omeprazole-14s-bottle-pack-label


    NDC: 25000-091-77
    Omeprazole Delayed-Release Tablets 20 mg 
    14's count (2 x 7's blister) Carton


    omeprazole-14s-blisterpack-carton


  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE 20 MG 
    omeprazole 20 mg tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-091
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code 91
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-091-772 in 1 CARTON08/12/2025
    17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:25000-091-761 in 1 CARTON08/12/2025
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21882908/12/2025
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-091)