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  5. Label Information: Good Sense Omeprazole

FDA Label for Good Sense Omeprazole

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USE
    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
    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. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Good Sense Omeprazole Product Label

The following document was submitted to the FDA by the labeler of this product L. Perrigo Company. 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 (In Each Tablet)



Omeprazole 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 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:

  • •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 medicines)
  • •prescription antiretrovirals (medicines for HIV infection)
  • •methotrexate (arthritis medicine)

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

    • •take 1 tablet before eating in the morning
    • •do not crush or chew tablets
    • •place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
    • •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
    • •do not take this medicine with alcohol

      • Repeated 14-Day Course (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 before use. 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 20-25°C (68-77°F); keep product out of high heat and moisture

Inactive Ingredients



amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate


Questions Or Comments?



1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST


Package/Label Principal Display Panel



MELTech™

Melts In Your Mouth

Treats Frequent Heartburn!

Occurring 2 or More Days a Week

Omeprazole

Actual Size

Delayed Release Orally Disintegrating Tablets 20 mg

Strawberry Flavor

Acid Reducer

Melts In Your Mouth

Dissolves Without Water

14 Tablets

One 14-Day Course of Treatment

Compare to Prilosec OTC®


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