Label: OMEPRAZOLE tablet, delayed release

  • NDC Code(s): 62756-377-11, 62756-377-12, 62756-377-21, 62756-377-70, view more
    62756-377-79, 62756-377-96
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 29, 2019

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

  • Active ingredient(in each tablet)

    Omeprazole USP 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
    • 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 docotor befor 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 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 joint pain

  • 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)

  • 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. 
  • 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

    anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate.

    The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.

  • Questions or Comments?


    Call toll free 1-800-818-4555 weekdays.

  • Tips of 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 avoid big meals
    • If overweight, lose weight
    • Quit smoking
  • 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 Omeprazole 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 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. 

    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.

    • Children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
    • Omeprazole delayed-release tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief or heartburn.

    How to Take Omeprazole Delayed-Release Tablets 20 mg  

    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.

    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
    • 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 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 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 joint pain

    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

    • 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

    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 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 toll free 1-800-818-4555 weekdays.

    Distributed by:

    Sun Pharmaceutical Industries, Inc.

    Cranbury, NJ 08512

    Manufactured by:

    Sun Pharmaceutical Industries Limited

    Survey No. 259/15,

    Dadra-396 191, (U.T. of D & NH), India.

    PGPI0356

    ISS. 04/2019

  • Principal Display Panel - Foil

    62756-377-40
    Omeprazole Delayed-release Tablet
    20 mg
    Acid reducer
    PUSH THROUGH
    Mfg. by: Sun Pharmaceutical Ind Ltd., India.
    Dist. by: Sun Pharmaceutical Ind Inc., NJ 08512
    PGPF0520


    spl-omeprazole-foil
  • Principal Display Panel - Blister Carton

    NDC 62756-377-96
    Compare to Prilosec OTC ® *
    Treats Frequent Heartburn! (24 HR)


    Compare to Prilosec OTC ® *
    Omeprazole Delayed-release Tablets
    20 mg

    Acid Reducer

    SWALLOW - DO NOT CHEW
    28 (2 x 14) Unit-Dose Tablets
    TWO 14-DAY COURSES OF TREATMENT
    May take 1 to 4 days for full effect

    spl-omeprazole-carton-2
  • Principal Display Panel - Label


    NDC 62756-377-21
    TreatsFrequentHeartburn! (24 HR)
    Omeprazole Delayed-release Tablets
    20 mg
    Acid Reducer
    14 Tablets
    ONE 14-DAY COURSE OF TREATMENT
    May take 1 to 4 days for full effect
    spl-omeprazole-label

  • Principal Display Panel - Bottle Carton


    NDC 62756-377-11
    Compare to Prilosec OTC ® *
    Treats Frequent Heartburn(24 HR)
    Omeprazole Delayed-release Tablets
    20 mg
    Acid Reducer
    SWALLOW - DO NOT CHEW
    28 Tablets
    TWO 14-DAY COURSES OF TREATMENT
    May take 1 to 4 days for full effect
    spl-omeprazole-carton-28-tab

  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE 
    omeprazole tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-377
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) (UNII: 36BGF0E889)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    AMMONIA (UNII: 5138Q19F1X)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColorBROWN (brownish pink) Scoreno score
    ShapeOVAL (biconvex) Size12mm
    FlavorImprint Code 20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62756-377-211 in 1 CARTON01/01/2019
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62756-377-112 in 1 CARTON01/01/2019
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:62756-377-123 in 1 CARTON01/01/2019
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:62756-377-701 in 1 CARTON01/01/2019
    414 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:62756-377-962 in 1 CARTON01/01/2019
    514 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:62756-377-793 in 1 CARTON01/01/2019
    614 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20789101/01/2019
    Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203ANALYSIS(62756-377) , MANUFACTURE(62756-377)