OMEPRAZOLE MAGNESIUM - omeprazole magnesium capsule, delayed release 
OMEPRAZOLE MAGNESIUM- omeprazole magnesium capsule, delayed release 
FREDS

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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

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

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 sulfate, 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

fred's
Pharmacy

NDC 55315-367-31

Acid
Reducer

Omeprazole
DELAYED-RELEASE CAPSULES 20mg*

Treats Frequent Heartburn

14 CAPSULES
(SAFETY SEALED)
ONE 14-DAY COURSE
OF TREATMENT

Make take 1 to 4 days for full effect

Compare To The
Active Ingredient in
Prilosec OTC®**

14 ct Carton

Omeprazole Delayed-Release Capsules, 20 mg*, 42-count - Carton Label

fred's 
Pharmacy

NDC 55315-368-31

Acid Reducer

Omeprazole
DELAYED-RELEASE CAPSULES 20mg*

Treats Frequent Heartburn 

42 CAPSULES  (SAFETY SEALED)
THREE 14-DAY COURSES
OF TREATMENT

May take 1 to 4 days for full effect

Compare To The Active Ingredient in
Prilosec OTC®**

42 ct Carton

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

fred's
Pharmacy

NDC 55315-367-31

Acid
Reducer

Omeprazole
DELAYED-RELEASE CAPSULES 20mg*

Treats Frequent Heartburn 

14 CAPSULES (SAFETY SEALED)
ONE 14-DAY COURSE
OF TREATMENT*

May take 1 to 4 days for full effect

Bottle
OMEPRAZOLE MAGNESIUM  
omeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-367(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:55315-367-311 in 1 CARTON10/16/2015
114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887810/16/2015
OMEPRAZOLE MAGNESIUM 
omeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-368
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:55315-368-313 in 1 CARTON10/16/2015
114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887810/16/2015
Labeler - FREDS (005866116)

Revised: 3/2017
Document Id: b0461fd2-1ee8-0698-5fd2-d10a803f850e
Set id: 1b1c6d51-b158-a408-1678-765a97f70f5e
Version: 3
Effective Time: 20170317
 
FREDS