OMEPRAZOLE MAGNESIUM- omeprazole magnesium capsule, delayed release 
Gericare Pharmaceuticals

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Gericare Pharmaceuticals Omeprazole 759

Active ingredient (in each capsule)

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

Purpose

Acid reducer

Uses

Warnings

Allergy alert: Do not use if you are allergic to omeprazole

include:  skin reddening  blisters  rash
If an allergic reaction occurs, stop use and seek medical help
right away.

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 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 right away (1-800-222-1222).

Directions

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

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

Package label

1

OMEPRAZOLE MAGNESIUM 
omeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-759
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20.6 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
RAW SUGAR (UNII: 8M707QY5GH)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYPROMELLOSE 2208 (3 MPA.S) (UNII: 9H4L916OBU)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)  
GELATIN (UNII: 2G86QN327L)  
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)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
Colorpink, whiteScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code OMP20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-759-141 in 1 CARTON09/01/2016
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:57896-759-282 in 1 CARTON09/01/2016
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:57896-759-423 in 1 CARTON09/01/2016
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887804/01/2013
Labeler - Gericare Pharmaceuticals (611196254)
Registrant - Gericare Pharmaceuticals (611196254)

Revised: 10/2023
Document Id: 08f44528-66bd-21ff-e063-6394a90a1972
Set id: 0e1f5d7c-5956-3be7-e054-00144ff8d46c
Version: 6
Effective Time: 20231030
 
Gericare Pharmaceuticals