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Levothyroxine Sodium 0.05 MG Oral Tablet Euthyrox

1 INDICATIONS AND USAGE EUTHYROX is L-thyroxine (T4) indicated in pediatric and adult patients for: Hypothyroidism: As replacement 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. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) Hypothyroidism EUTHYROX is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression EUTHYROX is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer . Limitations of Use: EUTHYROX 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 EUTHYROX may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. EUTHYROX is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

provell pharmaceuticals, llc


5 years ago ROUND WHITE EM 50 Levothyroxine Sodium 0.05 MG Oral Tablet Euthyrox

ROUND WHITE EM 50

5 years ago ROUND WHITE EM 50 Levothyroxine Sodium 0.05 MG Oral Tablet Euthyrox

EM 50 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING EUTHYROX (

LEVOTHYROXINE SODIUM) tablets are uncoated, off-white, round and flat on both sides with a beveled edge, and a dividing score on both sides available as: Tablet Strength Tablet Markings Carton Marking and Blister Packaging Color NDC 30-count carton NDC 90-count carton 25 mcg “EM†and “25†orange NDC 72305-025-30 NDC 72305-025-90 50 mcg “EM†and “50†white NDC 72305-050-30 NDC 72305-050-90 75 mcg “EM†and “75†purple NDC 72305-075-30 NDC 72305-075-90 88 mcg “EM†and “88†olive NDC 72305-088-30 NDC 72305-088-90 100 mcg “EM†and “100†yellow NDC 72305-100-30 NDC 72305-100-90 112 mcg “EM†and “112†Rose NDC 72305-112-30 NDC 72305-112-90 125 mcg “EM†and “125†brown NDC 72305-125-30 NDC 72305-125-90 137 mcg “EM†and “137†turquoise NDC 72305-137-30 NDC 72305-137-90 150 mcg “EM†and “150†blue NDC 72305-150-30 NDC 72305-150-90 175 mcg “EM†and “175†lilac NDC 72305-175-30 NDC 72305-175-90 200 mcg “EM†and “200†pink NDC 72305-200-30 NDC 72305-200-90 Each 30-count carton contains 30 tablets with 2 blister packs. Each 90-count carton contains 90 tablets with 6 blister packs. Each blister pack contains 15 tablets placed in individual cavities. Store between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light and moisture, avoid heat. Do not separate the individual cavities containing the tablet from the intact blister and do not remove the individual tablets from blister packaging until ready to use.


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