Bedaquiline labels and packages: Difference between revisions
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==Labels and Packages== | |||
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 | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1534c9ae-4948-4cf4-9f66-222a99db6d0e#nlm34089-3 | publisher = | date = | accessdate = 23 December 2013 }}</ref> | 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].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1534c9ae-4948-4cf4-9f66-222a99db6d0e#nlm34089-3 | publisher = | date = | accessdate = 23 December 2013 }}</ref> | |||
188 Tablets | |||
Rx only | |||
Janssen a | |||
{| | |||
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| [[File:Bedaquiline06.jpg|700px|thumb]] | |||
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==References== | ==References== | ||
Latest revision as of 14:07, 24 December 2013
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Labels and Packages
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].[1]
188 Tablets
Rx only
Janssen a
 |
References
- ↑ "SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]". Retrieved 23 December 2013.
Adapted from the FDA Package Insert.