Label: OMEPRAZOLE AND SODIUM BICARBONATE capsule

  • NDC Code(s): 58602-725-05, 58602-725-57, 58602-725-60
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 21, 2024

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

  • Active ingredients (in each capsule)

    Omeprazole 20 mg
    Sodium Bicarbonate 1100 mg

  • Purpose

    Acid reducer
    Allows absorption of this omeprazole product

  • 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
    • a sodium-restricted diet
  • 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; although some people get complete relief of symptoms within 24 hours
  • 14-Day Course of Treatment

    • swallow 1 capsule with a glass of water at least 1 hour before eating in the morning
    • take every day for 14 days
    • do not take more than 1 capsule a day
    • do not chew or crush the capsule
    • do not open capsule and sprinkle on food
    • do not use for more than 14 days unless directed by your doctor
  • 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: sodium 303 mg
    • read the directions, warnings and accompanying label information before use 
    • store at 20° to 25°C (68° to 77°F)
    • tamper-evident: do not use if the blue band around the capsule is missing or broken. Do not use if foil inner seal imprinted with "Sealed for your protection" is missing, open or broken.
    • keep product out of high heat and humidity
    • protect product from moisture
  • Inactive ingredients

    citric acid anhydrous, croscarmellose sodium, FD&C blue #1 aluminum lake, gelatin, magnesium stearate, polysorbate 80, potassium sorbate, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide.

  • Questions or comments?

    Call 1-855-274-4122

  • How Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg
    Works For Your Frequent Heartburn

    Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg works differently from other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and Sodium Bicarbonate Capsules stops acid production at the source - the acid pump that produces stomach acid. Omeprazole and Sodium Bicarbonate Capsules is to be used once a day (every 24 hours), every day for 14 days.


    TIPS FOR MANAGING HEARTBURN

    • Do not lie flat or bend over soon after eating
    • Do not eat late at night or just before bedtime
    • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables
    • Eat slowly and do not eat big meals
    • If you are overweight, lose weight
    • If you smoke, quit smoking
    • Raise the head of your bed
    • Wear loose-fitting clothing around your stomach

    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/1100 mg (14 Capsules Container Label)

    AUROHEALTH
    NDC 58602-725-05

    CLINICALLY PROVEN TO
    Treats Frequent Heartburn

    Omeprazole and Sodium
    Bicarbonate
    Capsules

    •    
    Omeprazole 20 mg / Acid Reducer
    •    Sodium Bicarbonate 1100 mg /

            Allows Absorption of this Omeprazole Product

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

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Carton Label)

    AUROHEALTH
    NDC 58602-725-05

    *Compare to Zegerid OTC® Capsules
    Active Ingredients

    CLINICALLY PROVEN TO
    Treats Frequent Heartburn

    Omeprazole and Sodium
    Bicarbonate
    Capsules

    •    
    Omeprazole 20 mg / Acid Reducer
    •    Sodium Bicarbonate 1100 mg /

            Allows Absorption of this Omeprazole Product

    24 Hour

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


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Carton Label)



  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE AND SODIUM BICARBONATE 
    omeprazole and sodium bicarbonate capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-725
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (Blue band) Scoreno score
    ShapeCAPSULESize24mm
    FlavorImprint Code ZEG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-725-051 in 1 CARTON12/22/2023
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-725-603 in 1 CARTON12/22/2023
    214 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-725-572 in 1 CARTON12/22/2023
    314 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20492312/22/2023
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-725) , MANUFACTURE(58602-725)