24 HR Minocycline 105 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Minocycline hydrochloride extended-release tablets are a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. ( 1 ) 1.1 Indication Minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. 1.2 Limitations of Use Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [ see Clinical Studies (14) ]. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, minocycline hydrochloride extended-release tablets should be used only as indicated [ see Warnings and Precautions (5.11) ].
Mylan Pharmaceuticals Inc.
OVAL BROWN MX101
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Minocycline Hydrochloride Extended-Release Tablets, USP are available containing minocycline hydrochloride, USP equivalent to 80 mg or 105 mg of minocycline. The 80 mg extended-release tablets are pink, film-coated, round, unscored tablets imprinted with MX100 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4293-93 bottles of 30 tablets NDC 0378-4293-01 bottles of 100 tablets The 105 mg extended-release tablets are brown, film-coated, capsule shaped, unscored tablets imprinted with MX101 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4294-93 bottles of 30 tablets NDC 0378-4294-01 bottles of 100 tablets 16.2 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 16.3 Handling Keep out of reach of children. Protect from light, moisture, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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