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  5. Label Information: Omeprazole Magnesium

FDA Label for Omeprazole Magnesium

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH CAPSULE)
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. DO NOT USE IF YOU HAVE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    9. STOP USE AND ASK DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS
    16. TIPS FOR MANAGING HEARTBURN
    17. OMEPRAZOLE DELAYED-RELEASE CAPSULES, 20 MG*, 14-COUNT CARTON LABEL
    18. OMEPRAZOLE DELAYED-RELEASE CAPSULES, 20 MG*, 14-COUNT BOTTLE LABEL

Omeprazole Magnesium Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Health Corp.. 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.

Other



Drug Facts


Active Ingredient (In Each Capsule)



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


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 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 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 contact 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; 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



  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77° F) and protect from moisture


Inactive Ingredients



black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide, triethyl citrate


Questions



Call 1-888-375-3784


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


Omeprazole Delayed-Release Capsules, 20 Mg*, 14-Count Carton Label



CVS Health

Compare to the
active ingredient
in Prilosec OTC®**

Treats Frequent Heartburn!
Occuring 2 or more days a week

Omeprazole
DELAYED-RELEASE
CAPSULES 20 mg*
Acid reducer

14 CAPSULES
(SAFETY SEALED)

One 14-day course of treatment

carton_label_14_ct - carton

carton_label_14_ct - carton



Omeprazole Delayed-Release Capsules, 20 Mg*, 14-Count Bottle Label



CVS Health

Treats Frequent Heartburn!
Occuring 2 or more days a week

Omeprazole

DELAYED-RELEASE
CAPSULES 20 mg*
Acid reducer

14 CAPSULES (SAFETY SEALED)
One 14-day course of treatment

bottle_label_14_ct - bottle

bottle_label_14_ct - bottle


* Please review the disclaimer below.