thyroid porcine 60 mg
INDICATIONS & USAGE Niva Thyroid tablets are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS ). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.
nivagen pharmaceuticals, inc.
ROUND YELLOW N 60
N 60 ROUND YELLOW
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HOW SUPPLIED Niva Thyroid (thyroid tablets, USP) are supplied as follows: 15 mg (1/4 grain): A light yellow to buff color, round shape tablet, debossed with ‘N’ on one side and ‘15’ on the other side. Bottles of 100’s with child-resistant cap…………….NDC 75834-310-01 30 mg (1/2 grain): A light yellow to buff color, round shape tablet, debossed with ‘N’ on one side and ‘30’on the other side. Bottles of 100’s with child-resistant cap…………….NDC 75834-311-01 60 mg (1 grain): A light yellow to buff color, round shape tablet, debossed with ‘N’ on one side and ‘60’ on the other side. Bottles of 100’s with child-resistant cap…………….NDC 75834-312-01 90 mg (1 1/2 grain): A light yellow to buff color, round shape tablet, debossed with ‘N’ on one side and ‘90’ on the other side. Bottles of 100’s with child-resistant cap…………….NDC 75834-313-01 120 mg (2 grain): A light yellow to buff color, round shape tablet, debossed with ‘N’ on one side and ‘120’ on the other side. Bottles of 100’s with child-resistant cap…………….NDC 75834-314-01 180 mg (3 grain): A light yellow to buff color, round shape tablet, debossed with ‘N’ & breakline on one side and ‘180’ on the other side. Bottles of 100’s with child-resistant cap…………….NDC 75834-315-01 240 mg (4 grain): A light yellow to buff color, round shape tablet, debossed with ‘N’ on one side and ‘240’ on the other side. Bottles of 100’s with child-resistant cap…………….NDC 75834-316-01 300 mg (5 grain): A light yellow to buff color, round shape tablet, debossed with ‘N’ & breakline on one side and ‘300’ on the other side. Bottles of 100’s with child-resistant cap…………….NDC 75834-317-01 Note: (T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis.) Store in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). *All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalence. Each person recommending a prescription substitution using this product shall make such recommendations based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients, and chemical information provided herein. Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA Toll free number: 1-877-977-0687 Revision: 03/2023
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