OMEPRAZOLE MAGNESIUM- omeprazole magnesium capsule, delayed release 
Kaiser Permanente

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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 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
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088

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 1-800-FDA-1088 (1-800-332-1088)

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, 28-count - Carton Label

NDC 0179-8104-28

KAISER PERMANENTE®

Omeprazole
Delayed-release capsules
20 mg*
Acid reducer
Treats frequent heartburn
occuring 2 or more days a week

**Compare to Prilosec OTC®

28 CAPSULES
Two 14-day courses of treatment

carton_label_28_ct


Omeprazole Delayed-Release Capsules, 20 mg, 14-count - Bottle Label

NDC 0179-8104-14

KAISER PERMANENTE®

Omeprazole 
Delayed-release capsules
20 mg*
Acid reducer
Treats frequent heartburn 
occuring 2 or more days a week

**Compare to Prilosec OTC®

14 CAPSULES  
One 14-day course of treatment

bottle_label_14_ct

OMEPRAZOLE MAGNESIUM 
omeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0179-8104(NDC:55111-397)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (omeprazole - UNII:KG60484QX9) omeprazole20 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
Gelatin (UNII: 2G86QN327L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYPROMELLOSE 2208 (3 MPA.S) (UNII: 9H4L916OBU)  
Magnesium Oxide (UNII: 3A3U0GI71G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)  
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
RAW SUGAR (UNII: 8M707QY5GH)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Product Characteristics
ColorWHITE, PINKScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code OMP20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0179-8104-141 in 1 CARTON01/01/201601/04/2016
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0179-8104-282 in 1 CARTON01/01/201603/31/2020
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0179-8104-423 in 1 CARTON01/01/201603/31/2020
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887801/01/201603/31/2020
Labeler - Kaiser Permanente (053052619)

Revised: 11/2021
 
Kaiser Permanente