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  5. Label Information: Acid Reducer

FDA Label for Acid Reducer

View Indications, Usage & Precautions

Table of Contents

    1. TIPS FOR MANAGING HEARTBURN
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    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 YOU ARE
    9. STOP USE AND ASK A 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. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 MG (14 TABLET BOTTLE)
    17. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 MG CONTAINER CARTON LABEL

Acid Reducer Product Label

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

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

Active Ingredient (In Each Tablet)



Omeprazole delayed-release tablet 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


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 (1-800-222-1222)  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 tablet with a glass of water before eating in the morning
    • 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
    • swallow whole. Do not chew or crush tablets.

      • 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° to 25°C (68° to 77° F) and protect from moisture

Inactive Ingredients



crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide,  triethyl citrate and yellow iron oxide.


Questions?



Call 1-855-274-4122

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

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


Package Label-Principal Display Panel - 20 Mg (14 Tablet Bottle)



LEADERTM          
NDC 70000-0521-1
24 Hour
Omeprazole
Delayed-Release Tablets, 20 mg / Acid Reducer
Treats Frequent Heartburn
May take 1 to 4 days for full effect
See current Drug Facts 14 TABLETS One 14-Day Course of Treatment



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle) - omerprazole fig1

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle) - omerprazole fig1



Package Label-Principal Display Panel - 20 Mg Container Carton Label



LEADERTM
NDC 70000-0521-1
24 Hour
Omeprazole
Delayed-Release Tablets, 20 mg
Acid Reducer
Actual Size
Treats Frequent Heartburn
May Take 1 to 4 Days for Full Effect
See current Drug Facts

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14 TABLETS
One 14-Day Course of Treatment



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label - omerprazole fig2

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label - omerprazole fig2



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