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Acid Reducer (omeprazole magnesium 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

Acid Reducer tablet, delayed release - (omeprazole magnesium 20 mg) image

  1. FDA Adverse Reactions

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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

Drug Facts


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.•  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 way.

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

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 20º to 25ºC (68º to 77º F) and protect from moisture

Inactive Ingredients


crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate 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: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009

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


AUROHEALTH             NDC 58602-729-05 See current Drug Facts Omeprazole Delayed-Release Tablets 20 mg ACID REDUCER Treats Frequent Heartburn! 24 HR 14 TABLETS 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 58602-729-05                                                        Compare to Prilsec OTC® See current Drug Facts                        Active Ingredient*

Omeprazole Delayed-Release Tablets 20 mg ACID REDUCER Treats Frequent Heartburn! 24 HR 14 TABLETS One 14-day course of treatment May take 1 to 4 days for full effect

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


AUROHEALTH NDC 58602-729-65                                                                   Compare to Prilosec OTC® See current Drug Facts                      Active Ingredient* Omeprazole Delayed-Release Tablets 20 mg ACID REDUCER Treats Frequent Heartburn! 24 HR 14 (2x7) TABLETS 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 14(1x14) Tablets


AUROHEALTH NDC 58602-729-01                                                                                      Compare to Prilosec OTC® See current Drug Facts                                                       Active Ingredient* Omeprazole Delayed-Release Tablets 20 mg ACID REDUCER Treats Frequent Heartburn! 24 HR 14 (1x14) TABLETS 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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