displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 50 and 100 mg tablets for oral administration. Metoprolol tartrate, USP is 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is:
(C15H25NO3)2•C4H6O6 M.W. 684.82
Metoprolol tartrate, USP is a white, practically odorless, crystalline powder. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether.
Metoprolol Tartrate Tablets USP, for oral administration, contain 50 mg or 100 mg of metoprolol tartrate, USP. In addition, each tablet contains the inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, talc, and titanium dioxide. The 50 mg tablets contain D&C Red No. 30 Aluminum Lake, and the 100 mg tablets contain FD&C Blue No. 1 Lake and FD&C Blue No. 2 Aluminum Lake.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Metoprolol Tartrate Tablets USP are available as follows:
50 mg: Pink, round, biconvex, film coated tablets, scored in half on one side with the numbers “93” and “733” on each side of the score. Plain on the other side. They are packaged in bottles of 100 and 1000 tablets.
100 mg: Mottled blue, round, biconvex, film coated tablets, scored in half on one side with the numbers “93” and “734” on each side of the score. Plain on the other side. They are packaged in bottles of 100 and 1000 tablets.
Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature].
Protect from moisture and heat.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872, X6351 or email@example.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured In India By:
EMCURE PHARMACEUTICALS LTD.
Hinjwadi, Pune, India
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. M 3/2013
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4