Omeprazole/Bicarbonate (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 20 mg Capsule Bottle Label

NDC 69367-195-30
Rx Only

Omeprazole and Sodium
Bicarbonate Capsules

20 mg/1100 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

30 Capsules

Westminster Pharmaceuticals

PRINCIPAL DISPLAY PANEL — 40 mg Capsule Bottle Label

NDC 69367-196-30
Rx Only

Omeprazole and Sodium
Bicarbonate Capsules

40 mg/1100 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

30 Capsules

Westminster Pharmaceuticals

OMEPRAZOLE/BICARBONATE omeprazole and sodium bicarbonate capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-195 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Omeprazole (Omeprazole) Omeprazole 20 mg Sodium Bicarbonate (Bicarbonate Ion) Sodium Bicarbonate 1100 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM SODIUM STEARYL FUMARATE GELATIN, UNSPECIFIED SODIUM LAURYL SULFATE FERROSOFERRIC OXIDE PROPYLENE GLYCOL BUTYL ALCOHOL TITANIUM DIOXIDE ALCOHOL ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE SHELLAC AMMONIA

Product Characteristics Color BLUE (Opaque-White) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code SG;363 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69367-195-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207476 07/27/2018

OMEPRAZOLE/BICARBONATE omeprazole and sodium bicarbonate capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-196 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Omeprazole (Omeprazole) Omeprazole 40 mg Sodium Bicarbonate (Bicarbonate Ion) Sodium Bicarbonate 1100 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM SODIUM STEARYL FUMARATE GELATIN, UNSPECIFIED SODIUM LAURYL SULFATE FERROSOFERRIC OXIDE PROPYLENE GLYCOL BUTYL ALCOHOL TITANIUM DIOXIDE ALCOHOL ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE SHELLAC AMMONIA

Product Characteristics Color BLUE (Opaque-White) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code SG;364 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69367-196-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207476 07/27/2018

Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 04/2022 Westminster Pharmaceuticals, LLC