24 HR Minocycline 65 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 ) ].
teva pharmaceuticals usa, inc.
OVAL PURPLE TV 2134
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Minocycline Hydrochloride Extended-release Tablets USP are available as follows: The 55 mg extended-release tablets are pink, capsule-shaped, unscored, film-coated tablets containing minocycline hydrochloride, USP equivalent to 55 mg minocycline and debossed with “TV†on one side and “H1†on the other side, available in bottles of 30 tablets (NDC 0093-7741-56). The 65 mg extended-release tablets are purple, capsule-shaped, unscored, film-coated tablets containing minocycline hydrochloride, USP equivalent to 65 mg minocycline and debossed with “TV†on one side and “2134†on the other side, available in bottles of 30 tablets (NDC 0093-2134-56). The 80 mg extended-release tablets are white, capsule-shaped, unscored, film-coated tablets containing minocycline hydrochloride, USP equivalent to 80 mg minocycline and debossed with “TV†on one side and “H2†on the other side, available in bottles of 30 tablets (NDC 0093-7742-56). The 105 mg extended-release tablets are brown, capsule-shaped, unscored, film-coated tablets containing minocycline hydrochloride, USP equivalent to 105 mg minocycline and debossed with “TV†on one side and “H3†on the other side, available in bottles of 30 tablets (NDC 0093-7743-56). The 115 mg extended-release tablets are green, capsule-shaped, unscored, film-coated tablets containing minocycline hydrochloride, USP equivalent to 115 mg minocycline and debossed with “TV†on one side and “2133†on the other side, available in bottles of 30 tablets (NDC 0093-2133-56). 16.2 Storage Store at 20º to 25°C (68° to 77ºF) [See USP Controlled Room Temperature]. 16.3 Handling KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Protect from light, moisture, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
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