Omeprazole (Page 9 of 9)
15 REFERENCES
1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically—Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol, 20, No. 2, NCCLS, Wayne, PA, January 2000.
16 HOW SUPPLIED/STORAGE AND HANDLING
Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg
and body ‘R157’ with black ink. The capsules are supplied in bottles of 60 and 120.
Bottles of 60 NDC 42254-043-60
Bottles of 120 NDC 42254-043-72
Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mg
and body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 10 x 10.
Bottles of 7 NDC 42254-053-07
Bottles of 14 NDC 42254-053-14
Bottles of 30 NDC 42254-053-30
Bottles of 60 NDC 42254-053-60
Bottles of 90 NDC 42254-053-90
Bottles of 120 NDC 42254-053-72
Storage
Store delayed-release capsules in a tight container protected from light and moisture.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Omeprazole delayed-release capsules should be taken before eating. Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.
For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.
Manufactured by:
Dr. Reddy’s Laboratories Limited
Bachepalli – 502 325 INDIA
Issued:0109
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Principal Display Panel
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Labeler — Rebel Distributors Corp (118802834) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Rebel Distributors Corp | 118802834 | RELABEL, REPACK |
Revised: 12/2011 Rebel Distributors Corp
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