OMEPRAZOLE MAGNESIUM- omeprazole magnesium capsule, delayed release 
CVS Health Corp.

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Omeprazole - CVS

Active ingredient (in each capsule)

*Omeprazole delayed-release capsules 20 mg
(equivalent to 20.6 mg omeprazole magnesium)

Purpose

Acid reducer

Use

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 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

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

Other information

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

Omeprazole Delayed-Release Capsules, 20 mg*, 14-count Carton Label

CVS Health

Compare to the
active ingredient
in Prilosec OTC®**

Treats Frequent Heartburn!
Occuring 2 or more days a week

Omeprazole
DELAYED-RELEASE
CAPSULES 20 mg*

Acid reducer

14 CAPSULES
(SAFETY SEALED)

One 14-day course of treatment

carton_label_14_ct


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

CVS Health

Treats Frequent Heartburn!
Occuring 2 or more days a week

Omeprazole

DELAYED-RELEASE
CAPSULES 20 mg*
Acid reducer

14 CAPSULES (SAFETY SEALED)
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:69842-027(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:69842-027-141 in 1 CARTON11/01/2011
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69842-027-282 in 1 CARTON11/01/2011
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69842-027-423 in 1 CARTON11/01/2011
314 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:69842-027-013 in 1 CARTON10/01/2015
414 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887811/01/2011
Labeler - CVS Health Corp. (062312574)

Revised: 3/2017
Document Id: 551ec593-ac51-6833-fd26-0570cc60539a
Set id: 3bbfa87d-f8b7-19bd-9f12-39cba31ae0b3
Version: 3
Effective Time: 20170315
 
CVS Health Corp.