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Omeprazole (omeprazole 20 mg) Dailymed

  1. Human OTC
  2. Proton Pump Inhibitor
  3. Aurohealth LLC

Generic: omeprazole is used for the treatment of Duodenal Ulcer Esophagitis Gastroesophageal Reflux Heartburn Stomach Ulcer Zollinger-Ellison Syndrome Helicobacter Infections

Omeprazole capsule, delayed release - (omeprazole 20 mg) image

IMPRINT: OZM 20     SHAPE: capsule
    COLOR: pink

  1. FDA Adverse Reactions

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Active Ingredient (in Each Capsule)


Omeprazole delayed-release capsules, USP 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.

•   Omeprazole may cause severe skin reactions. Symptoms may include:

     •  skin reddening •  bulers •  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

Otc - Ask Doctor/pharmacist Section


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; 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

  • each capsule contains: calcium 110 mg
  • 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
  • FDA approved dissolution test specifications differ from USP.

Inactive Ingredients


black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, hypromellose, iron oxide red, macrogol, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, mono and di-glycerides, polysorbate 80, polyvinyl alcohol-part. hydrolyzed, potassium hydroxide, shellac, sodium lauryl sulphate, sugar spheres [liquid glucose, starch (maize), sucrose], talc, titanium dioxide, triethyl citrate.

Questions?


Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

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

Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in IndiaCode: TS/DRUGS/22/2009

Package Label-principal Display Panel - 20 Mg (14 Capsules Bottle)


AUROHEALTH             NDC 58602-837-05 See current Drug Facts Omeprazole Delayed-Release Capsules, USP 20 mg/Acid Reducer Treats Frequent Heartburn! 24 HR 14 Capsules One 14-Day Course of Treatment May take 1 to 4 days for full effect

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


AUROHEALTH NDC 58602-837-05 See current Drug Facts *Compare to the activeingredient in Prilosec OTC® Omeprazole Delayed-Release Capsules, USP 20 mg/Acid Reducer Treats Frequent Heartburn! 24 HR OZM 20 14 Capsules One 14-Day Course of Treatment May Take 1 to 4 days for full effect

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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