Bedaquiline labels and packages: Difference between revisions
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This Medication Guide has been approved by the U.S. Food and Drug Administration | |||
Issued: October 2013 | |||
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label | |||
NDC 59676-701-01 | |||
Sirturo™ | |||
(bedaquiline) tablets | |||
100 mg | |||
Dispense Medication Guide | |||
to each patient | |||
Attention Pharmacist: Dispense in original | |||
container. Tablets dispensed outside the | |||
original container should be stored in a tight | |||
light-resistant container with an expiration | |||
date not to exceed 3 months. Store at 25°C | |||
(77°F); Excursions permitted to 15°C-30°C | |||
(59°F - 86°F).[See USP Controlled Room | |||
Temperature]. | |||
188 Tablets | |||
Rx only | |||
Janssen a | |||
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Revision as of 22:11, 23 December 2013
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
This Medication Guide has been approved by the U.S. Food and Drug Administration
Issued: October 2013
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
NDC 59676-701-01
Sirturo™ (bedaquiline) tablets
100 mg
Dispense Medication Guide to each patient
Attention Pharmacist: Dispense in original container. Tablets dispensed outside the original container should be stored in a tight light-resistant container with an expiration date not to exceed 3 months. Store at 25°C (77°F); Excursions permitted to 15°C-30°C (59°F - 86°F).[See USP Controlled Room Temperature].
188 Tablets
Rx only
Janssen a
References
- ↑ "SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]". Retrieved 23 December 2013.
Adapted from the FDA Package Insert.