24 HR Minocycline 115 MG Extended Release Oral Tablet
1 INDICATIONS & USAGE Minocycline hydrochloride extended-release tablets is 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 Indication Minocycline hydrochloride extended-release tablets is 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) ] .
Ascend Laboratories, LLC
CAPSULE GREEN 115
115 CAPSULE GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
MINOCYCLINE HYDROCHLORIDE extended-release tablets, USP are supplied as aqueous film coated tablets containing
MINOCYCLINE HYDROCHLORIDE equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg minocycline, are supplied as follows. The 45 mg extended release tablets are grey coloured capsule shaped film coated tablets, debossed with “45” on one side, plain on other side. Each tablet contains
MINOCYCLINE HYDROCHLORIDE equivalent to 45 mg minocycline, supplied as follows: NDC 67877-578-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-578-30 Bottle of 30 NDC 67877-578-01 Bottle of 100 NDC 67877-578-05 Bottle of 500 The 55 mg extended release tablets are pink colored capsule shaped film coated tablets, debossed with "55" on one side, plain on other side. Each tablet contains
MINOCYCLINE HYDROCHLORIDE equivalent to 55 mg minocycline, supplied as follows: NDC 67877-436-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-436-30 Bottle of 30 NDC 67877-436-01 Bottle of 100 NDC 67877-436-05 Bottle of 500 The 65 mg extended release tablets are blue coloured capsule shaped film coated tablets, debossed with “65” on one side, plain on other side. Each tablet contains
MINOCYCLINE HYDROCHLORIDE equivalent to 65 mg minocycline, supplied as follows: NDC 67877-643-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-643-30 Bottle of 30 NDC 67877-643-01 Bottle of 100 NDC 67877-643-05 Bottle of 500 The 80 mg extended release tablets are greyish brown colored capsule shaped film coated tablets, debossed with "80'' on one side, plain on other side. Each tablet contains
MINOCYCLINE HYDROCHLORIDE equivalent to 80 mg minocycline, supplied as follows: NDC 67877-437-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-437-30 Bottle of 30 NDC 67877-437-01 Bottle of 100 NDC 67877-437-05 Bottle of 500 The 90 mg extended release tablets are yellow coloured capsule shaped film coated tablets, debossed with “90” on one side, plain on other side. Each tablet contains
MINOCYCLINE HYDROCHLORIDE equivalent to 90 mg minocycline, supplied as follows: NDC 67877-576-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-576-30 Bottle of 30 NDC 67877-576-01 Bottle of 100 NDC 67877-576-05 Bottle of 500 The 105 mg extended release tablets are purple colored capsule shaped film coated tablets, debossed with "105'' on one side, plain on other side.Each tablet contains
MINOCYCLINE HYDROCHLORIDE equivalent to 105 mg minocycline, supplied as follows: NDC 67877-438-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-438-30 Bottle of 30 NDC 67877-438-01 Bottle of 100 NDC 67877-438-05 Bottle of 500 The 115 mg extended release tablets are green coloured capsule shaped film coated tablets, debossed with “115” on one side, plain on other side. Each tablet contains
MINOCYCLINE HYDROCHLORIDE equivalent to 115 mg minocycline, supplied as follows: NDC 67877-644-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-644-30 Bottle of 30 NDC 67877-644-01 Bottle of 100 NDC 67877-644-05 Bottle of 500 The 135 mg extended release tablets are pink (orange brown) coloured capsule shaped film coated tablets, debossed with “135” on one side, plain on other side. Each tablet contains
MINOCYCLINE HYDROCHLORIDE equivalent to 135 mg minocycline, supplied as follows: NDC 67877-577-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-577-30 Bottle of 30 NDC 67877-577-01 Bottle of 100 NDC 67877-577 -05 Bottle of 500 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 tight, light-resistant container with child-resistant closure.
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