Omeprazole Tablets
Name: Omeprazole Tablets
Bulk 7-Count Blister Pack Carton Label
70 Tablets
OMEPRAZOLE DR TABLETS 20 MG OTC
Acid reducer
FOR REPACKAGING ONLY
Manufactured by: DEXCEL® LTD.
Southern Industrial Zone, Or Akiva 30600, Israel
- Store at 15° - 25°C (59° - 77°F)
- Keep product out of high heat and humidity
- Protect product from moisture
OMEPRAZOLE DELAYED RELEASE
omeprazole tablet, delayed release |
| Product Information | | Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC:64861-303 | | Route of Administration | ORAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Omeprazole (Omeprazole) | Omeprazole | 20 mg | |
| Inactive Ingredients | | Ingredient Name | Strength | | Carnauba Wax | | | Ferric Oxide Red | | | Ferric Oxide Yellow | | | Hypromellose | | | Hypromellose Acetate Succinate 12070923 (3 MM2/S) | | | Lactose Monohydrate | | | Ethanolamine | | | Propylene Glycol | | | Sodium Lauryl Sulfate | | | Sodium Starch Glycolate Type A Potato | | | Sodium Stearate | | | Sodium Stearyl Fumarate | | | Talc | | | Titanium Dioxide | | | Triethyl Citrate | | |
| Product Characteristics | | Color | brown (brownish) | Score | no score | | Shape | OVAL (capsule-shaped) | Size | 13mm | | Flavor | | Imprint Code | 20 | | Contains | | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:64861-303-01 | 14 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE, PLASTIC | | 2 | NDC:64861-303-02 | 10 BLISTER PACK (BLISTER PACK) in 1 CARTON | | 2 | | 7 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK | | 3 | NDC:64861-303-03 | 2 BLISTER PACK (BLISTER PACK) in 1 CARTON | | 3 | | 7 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA | NDA022032 | 03/01/2008 | | |
| Labeler - Dexcel Ltd. (600534200) |
| Establishment |
| Name | Address | ID/FEI | Operations |
| Dexcel Ltd. | | 600534200 | analysis, label, manufacture, pack |
Revised: 04/2010 Dexcel Ltd.
