Buprenorphine Hydrochloride Sublingual Buprenorphine 8 MG Sublingual Tablet
1 INDICATIONS AND USAGE Buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablets contain buprenorphine, a partial opioid agonist, and are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )
Mylan Pharmaceuticals Inc.
ROUND WHITE M 924
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Buprenorphine Hydrochloride Sublingual Buprenorphine 8 MG Sublingual Tablet
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16 HOW SUPPLIED/STORAGE AND HANDLING Buprenorphine Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine. The 2 mg sublingual tablets are white, round, unscored tablets debossed with M over 923 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with M over 924 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see Patient Counseling (17) ]. Store buprenorphine sublingual tablets securely and dispose of properly [see Patient Counseling Information (17) ] .
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