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Omeprazole Magnesium by The Kroger Co.

Dosage form: capsule, delayed release
Ingredients: OMEPRAZOLE MAGNESIUM 20mg
Labeler: The Kroger Co.
NDC Code: 59450-012

Drug Facts

Active ingredient

Omeprazole magnesium delayed-release capsule 20.6 mg

(equivalent to 20 mg omeprazole)

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; 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

Pregnancy/Breast-feeding

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

Storage

  • 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

PRINCIPAL DISPLAY PANEL

Omeprazole Magnesium Delayed-Release Capsules, 20. 6 mg - Container Label and carton 42 count


OMEPRAZOLE MAGNESIUM 
omeprazole magnesium 20.6mg capsules capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-012(NDC:55111-397)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (omeprazole) omeprazole20 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
Gelatin 
GLYCERYL MONOSTEARATE 
HYPROMELLOSE 2208 (3 MPA.S) 
Magnesium Oxide 
MAGNESIUM STEARATE 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) 
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A 
CELLULOSE, MICROCRYSTALLINE 
Polysorbate 80 
POTASSIUM HYDROXIDE 
PROPYLENE GLYCOL 
FERRIC OXIDE RED 
SHELLAC 
SILICON DIOXIDE 
RAW SUGAR 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Sodium Lauryl Sulfate 
Product Characteristics
ColorWHITE, PINKScoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeOMP20
Contains    
Packaging
#Item CodePackage Description
1NDC:59450-012-272 BOTTLE in 1 CARTON
114 CAPSULE, DELAYED RELEASE in 1 BOTTLE
2NDC:59450-012-013 BOTTLE in 1 CARTON
214 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887801/01/2016
Labeler - The Kroger Co. (006999528)

Revised: 01/2016
 
The Kroger Co.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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