Home > Pill Identifier > omeprazole 20 MG (omeprazole magnesium 20.6 MG) Delayed Release Tablet

Pill Identifier Information of omeprazole 20 MG (omeprazole magnesium 20.6 MG) Delayed Release Tablet

Drug Information

omeprazole 20 MG (omeprazole magnesium 20.6 MG) Delayed Release Tablet

Imprint: 20
Shape: C48345
Color: C48332
Ingredients: Omeprazole
Size: 13.00
Score: 1
Rxtty: SY
Author: Weeks & Leo Co., Inc.
Inactive Ingredients: CARNAUBA WAX / FERRIC OXIDE RED / FERRIC OXIDE YELLOW / HYPROMELLOSES / HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) / LACTOSE MONOHYDRATE / MONOETHANOLAMINE / PROPYLENE GLYCOL / SODIUM LAURYL SULFATE / SODIUM STARCH GLYCOLATE TYPE A POTATO / SODIUM STEARATE / SODIUM STEARYL FUMARATE / TALC / TITANIUM DIOXIDE / TRIETHYL CITRATE>

Complete Information

  • Active Ingredient (In each tablet)


    Omeprazole delayed-release tablet, 20 mg
  • 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

    Do Not Use

    if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.  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.

    • had heartburn over 3 months.  This may be a sign of a more serious condition.
    • heartburn with lightheadedness, sweating or dizziness
    • chest pain or shoulder pain with shortness or breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • unexplained weight loss
    • nausea or vomiting
    • stomach pain

    Ask a doctor or pharmacist before use

    if you are taking

    • warfarin or clopidogrel (blood-thinning medicine)
    • prescription antifungal or anti-yeast medicines
    • diazepam (anxiety medicine)
    • digoxin (heart medicine)
    • tacrolimus (immune system medicine)
    • preswcription antretroivirals (medicines for HIV infection)

    • Stop use and ask a doctor if
    • side effects occur.  You may report side effects to FDA at 1-800-FDA-1088
    • 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

    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


    • 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, although some people get complete relief of symptoms within 24 hours
    14-Day Course of Treatment
    • Repeated 14-Day Courses (if needed)
  • Other information

  • Inactive ingredients

    carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate

  • Tamper-evident:

    do not use if any blister unit is torn, broken, or shows any signs of tampering.

  • Carton Label - 14 tablets

    Treats Frequent Heartburn!
    Occurring 2 or More Days a Week

    Omeprazole
    delayed release tablets 20 mg
    acid reducer

    14 TABLETS
    One 14-day course of treatment

    Comparare to Prilosec* OTC active ingredient only

    Pharmacist Recommended

    14 tablet box front

    14 tablet box front

    14 tablet box rear

    14 tablet box rear

  • Blister Label


    Omeprazole DR Tablets
    20 mg
    Acid reducer
    Push tablet through foil.
    Dexcel Ltd.
    1 Dexcel St.  Or Akiva
    30600, Israel

    Do not chew or crush tablets

    Do not crush tablets in food

    Blister Label

  • Patient Package Insert


    Omeprazole Delayed Release Tablets 20 mg

    Acid Reducer

    Please read all of this package insert before taking Omeprazole Delayed Release Tablets 20 mg.  Save this to read, as you need.
    How Omeperazole Delayed Release Tablets 20 mg Work For Your Frequent Heartburn

    Omeprazole Delayed Release Tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers.  Omeprazole Delayed Release Tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid.  Omeprazole Delayed Release Tablets 20 mg are to be used once a day (every 24 hours), every day for 14 days.

    What to Expect When Using Omeprazole Delayed Release Tablets 20 mg

    Omeprazole Delayed Release Tablets 20 mg are a different type of medicine from antacids and other acid reducers.  Omeprazole Delayed Release Tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours.  Make sure you take the entire 14 days of dosing to treat your frequent heartburn.

    Safety Record

    For years, doctors have prescribed omeprazole to treat acid-related conditions in millions of people safely.

    Who Should Take Omeprazole Delayed Release Tablets 20 mg

    This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week.
    How to Take Omeprazole Delayed Release Tablets 20 mg

    14-Day Course of Treatment
    It is important not to chew or crush these tablets, or crush the tablets in food.  This decreases how well Omeprazole Delayed Release Tablets 20 mg work.

    When to Take Omeprazole Delayed Release Tablets 20 mg Again

    You may repeat a 14-day course of therapy every 4 months.

    When to Talk to Your Doctor

    Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

    Warnings and When to Ask Your Doctor

    Allergy alert:  Do not use if you are allergic to omeprazole

    Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.  These may be signs of a serious condition.  See your doctor.

    Ask a doctor before use if you have
    Ask a doctor or pharmacist before use if you are taking
    Stop use and ask a doctor if 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.  (1-800-222-1222)

    Tips for Managing Heartburn
    How are Omeprazole Delayed Release Tablets 20 mg Sold

    Omeprazole Delayed Release Tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes.  These sizes contain one, two and three 14-day courses of treatment, respectively.  Do not use for more than 14 days in a row unless directed by your doctor.  For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

    For Questions or Comments About Omeprazole Delayed Release Tablets 20 mg

    Call 1-800-719-9260

    Made in Israel

    Manufactured by:
    DEXCEL® LTD.
    Southern Industrial Zone
    Or Akiva 30600, Israel


  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE  DELAYED RELEASE
    omeprazole tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-257(NDC:64861-303)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) (UNII: 36BGF0E889)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorBROWN (brownish) Scoreno score
    ShapeOVAL (capsule-shaped) Size13mm
    FlavorImprint Code 20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11383-257-612 in 1 CARTON
    114 in 1 BLISTER PACK
    2NDC:11383-257-161 in 1 CARTON
    214 in 1 BLISTER PACK
    3NDC:11383-257-433 in 1 CARTON
    314 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02203207/12/2011
    Labeler - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028REPACK(11383-257, 11383-257)