levothyroxine sodium 0.2 MG Oral Tablet Synthroid
1 INDICATIONS AND USAGE Hypothyroidism SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid -Stimulating Hormone, TSH) Suppression SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions ( 5.1 )]. SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. SYNTHROID is a L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. ( 1 ) Limitations of Use: not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis
AbbVie Inc.
ROUND PINK SYNTHROID 200
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied SYNTHROID (
LEVOTHYROXINE SODIUM, USP) tablets are supplied as follows ( Table 11 ): Table 11: SYNTHROID Tablet Presentations Strength (mcg) Color/Shape Tablet Markings NDC# for bottles of 90 NDC # for bottles of 1000 NDC # for unit dose cartons of 100 25 orange/round “SYNTHROID” and “25” 0074-4341-90 0074-4341-19 -- 50 white/round “SYNTHROID” and “50” 0074-4552-90 0074-4552-19 0074-4552-11 75 violet/round “SYNTHROID” and “75” 0074-5182-90 0074-5182-19 0074-5182-11 88 olive/round “SYNTHROID” and “88” 0074-6594-90 0074-6594-19 -- 100 yellow/round “SYNTHROID” and “100” 0074-6624-90 0074-6624-19 0074-6624-11 112 Rose/round “SYNTHROID” and “112” 0074-9296-90 0074-9296-19 -- 125 brown/round “SYNTHROID” and “125” 0074-7068-90 0074-7068-19 0074-7068-11 137 turquoise/round “SYNTHROID” and “137” 0074-3727-90 0074-3727-19 -- 150 blue/round “SYNTHROID” and “150” 0074-7069-90 0074-7069-19 0074-7069-11 175 lilac/round “SYNTHROID” and “175” 0074-7070-90 0074-7070-19 -- 200 pink/round “SYNTHROID” and “200” 0074-7148-90 0074-7148-19 0074-7148-11 300 green/round “SYNTHROID” and “300” 0074-7149-90 0074-7149-19 -- Storage and Handling Store SYNTHROID at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). SYNTHROID tablets should be protected from light and moisture.
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