HOW SUPPLIED
Triazolam Tablets USP for oral administration are available as:
0.125 mg white, unscored, oval-shaped tablets (Identified 54 519).
NDC 0054-8858-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.
NDC 0054-4858-06: Bottles of 10 tablets.
NDC 0054-4858-29: Bottles of 500 tablets.
0.25 mg blue, scored, oval-shaped tablets (Identified 54 620).
NDC 0054-8859-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.
NDC 0054-4859-06: Bottles of 10 tablets.
NDC 0054-4859-29: Bottles of 500 tablets.
Store at controlled room temperature
15°-30°C (59°-86°F).
The text of the patient insert for triazolam is set forth below:
INFORMATION FOR THE PATIENT ABOUT TRIAZOLAM TABLETS, USP
INTRODUCTION
Triazolam tablets are intended to help you sleep. It is one of several benzodiazepine sleeping pills that have generally similar properties. Anyone who is considering using one of these medications should be aware of both their benefits and several important risks and limitations, including diminishing effectiveness with continued use and the possible development of dependence (addiction) and possibly mental changes particularly when the drugs are used for more than a few days to a week. This patient information statement is intended to provide you with knowledge about this class of medications in general and about triazolam in particular that will be useful to guide you in the safe use of this product. BUT IT SHOULD NOT REPLACE A DISCUSSION BETWEEN YOU AND YOUR PHYSICIAN ABOUT THE RISKS AND BENEFITS OF TRIAZOLAM.
This leaflet will focus on the beneficial and adverse effects of all members of this class of medications, as well as some specific information about triazolam. There are some differences among these products, and your physician may wish to discuss any specific advantages and disadvantages of particular members of this drug class with you.
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