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  5. Label Information: Omeprazole And Sodium Bicarbonate

FDA Label for Omeprazole And Sodium Bicarbonate

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE IF YOU HAVE:
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. HOW OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES WORK FOR YOUR FREQUENT HEARTBURN
    16. WHAT TO EXPECT WHEN USING OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES
    17. TIPS FOR MANAGING HEARTBURN
    18. HOW ARE OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES SOLD
    19. PRINCIPAL DISPLAY PANEL - 14 CAPSULE CARTON
    20. PRINCIPAL DISPLAY PANEL - 28 CAPSULE CARTON
    21. PRINCIPAL DISPLAY PANEL - 42 CAPSULE CARTON

Omeprazole And Sodium Bicarbonate Product Label

The following document was submitted to the FDA by the labeler of this product Aurolife Pharma, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient(S)




Omeprazole 20 mg
Sodium Bicarbonate 1100 mg


Purpose




Acid reducer
Allows absorption of this omeprazole product


Use(S)



  • treats frequent heartburn (occurs 2 or more days a week)
  • not intended for immediate relief of hearburn. 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:



  • touble or pain swallowing food
  • vomiting with blood
  • 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.
  • heartburn with lightheadedness, sweating or diziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulder; or lightheadedness
  • frequent chest pain
  • 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



  • warfarin, clopidogrel or cilostazol (blood-thinning medicines)
  • prescription antifungal or anti-yeast medicines
  • diazepam (anxiety medicine)
  • digoxin (heart medicine)
  • tacrolimus or Mycophenolate mofetil (immune system medicine)
  • prescription antiretrovirals (medicines for HIV infection)
  • Methotrexate (arthiritis medicine)
  • any other prescription drugs, Sodium bicarbonate 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

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 contract a Poison Control Center right away.


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 one 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 ofen than every 4 months unless directed by a doctor
        • children under 18 years of age; ask a doctor. Heartburn in children may sometines be caused by a serious condition.

Other Information



  • each capsule contains: sodium 303 mg
  • read the direction, 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 is missing, open or broken.
  • keep product out of high heat and humidity
  • prtect product from moisture

Inactive Ingredients




citric acid, croscarmellose sodium, FD&C Blue # 1, FD&C Red # 3, gelatin, magnesium stearate NF, pharmaceutical ink, polysorbate 80, potassium hydroxide NF, potassium sorbate, propylene glycol, Shellac,sodium lauryl sulphate, titanium dioxide,    


Questions Or Comments?




Call toll-free 1-866-850-2876


How Omeprazole And Sodium Bicarbonate Capsules Work For Your Frequent Heartburn




Omeprazole and sodium bcarbonate capsules work differently form other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and sodium bicarbonate capsules stop acid production at the source-the acid pump that produces stomach acid. Omeprazole and sodium bicarbonate capsules are to be used once a day (every 24 hours), every day for 14 days.


What To Expect When Using Omeprazole And Sodium Bicarbonate Capsules




Omeprazole and sodium bicarbonate capsules is a different type of medicine from antacids and other acid reducers. Omeprazole and sodium bicarbonate capsules 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.


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 likelhy 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.

How Are Omeprazole And Sodium Bicarbonate Capsules Sold




Omeprazole and sodium bicarbonate capsules are availble in 14, 28 and 42 count sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use of 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.


Principal Display Panel - 14 Capsule Carton




* Compare to Zegerid OTC® Capsules                           NDC 13107-117-14
Active Ingredients


Treats Frequent Heartburn


Omeprazole and Sodium Bicarbonate Capsules

  • Omeprazole 20 mg / Acid Reducer
  • Sodium Bicarbonate 1100 mg / Allows Absorption of this Omperazole Product

    •                                 14 Capsules
    One 14-Day Course of Treatment

    Aurobindo

    omeprazole - omeprazole

    omeprazole - omeprazole




Principal Display Panel - 28 Capsule Carton




* Compare to Zegerid OTC® Capsules                 NDC 13107-117-28
Active Ingredients


Treats Frequent Heartburn


Omeprazole and Sodium Bicarbonate Capsules

  • Omeprazole 20 mg / Acid Reducer
  • Sodium Bicarbonate 1100 mg / Allows Absorption of this Omperazole Product

    •                                  28 Capsules
    Two 14-Day Course of Treatment

    Aurobindo

    omeprazole - omeprazole28ct

    omeprazole - omeprazole28ct



Principal Display Panel - 42 Capsule Carton




* Compare to Zegerid OTC® Capsules                          NDC 13107-117-42
Active Ingredients


Treats Frequent Heartburn


Omeprazole and Sodium Bicarbonate Capsules

  • Omeprazole 20 mg / Acid Reducer
  • Sodium Bicarbonate 1100 mg / Allows Absorption of this Omperazole Product

    •                                    42 Capsules
    Three 14-Day Course of Treatment

    Aurobindo

    omeprazole - omeprazole42ct

    omeprazole - omeprazole42ct



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