Label: OMEPRAZOLE capsule, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 19, 2024

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  • Active ingredient (in each capsule)

    Omeprazole delayed-release capsules, USP 20 mg
    (equivalent to 20.6 mg omeprazole magnesium USP)

  • 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 occurs, stop use and seek medical help right away.

  • 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)

  • 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 capsule with a glass of water before eating in the morning
    • take every day for 14 days
    • do not take more than 1 capsule a day
    • do not use for more than 14 days unless directed by your doctor
    • swallow whole. Do not chew or crush capsules.
  • 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

    • each capsule contains: calcium 110 mg
    • 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
    • FDA approved dissolution test specifications differ from USP.
  • Inactive ingredients

    black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, hypromellose, iron oxide red, macrogol, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, mono and di-glycerides, polysorbate 80, polyvinyl alcohol-part. hydrolyzed, potassium hydroxide, shellac, sodium lauryl sulphate, sugar spheres [liquid glucose, starch (maize), sucrose], talc, titanium dioxide, triethyl citrate.



  • Questions?

    Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

  • 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

    Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India
    Code: TS/DRUGS/22/2009

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Bottle)

    AUROHEALTH            
    NDC 58602-837-05

    See current Drug Facts

    Omeprazole
    Delayed-Release Capsules, USP
    20 mg/Acid Reducer
    Treats Frequent Heartburn!
    24 HR
    14 Capsules
    One 14-Day Course of Treatment
    May take 1 to 4 days for full effect
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label

    AUROHEALTH
    NDC 58602-837-05

    See current Drug Facts
    *Compare to the active
    ingredient in Prilosec OTC®

    Omeprazole
    Delayed-Release
    Capsules, USP
    20 mg/Acid Reducer
     Treats Frequent Heartburn!
    24 HR
    OZM 20

    14 Capsules
    One 14-Day Course of Treatment
    May Take 1 to 4 days for full effect

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label

  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE 
    omeprazole capsule, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-837
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorPINK (light pinkish red cap) , WHITE (White to off white body) Scoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code OZM;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-837-051 in 1 CARTON04/28/2023
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21320104/28/2023
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-837) , MANUFACTURE(58602-837)
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