PREMARIN (conjugated estrogens sustained release tablets) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares’ urine. It is a mixture of sodium estrone sulphate and sodium equilin sulphate. It contains concomitant components, as sodium sulphate conjugates, 17β-dihydroequilin, 17β-estradiol, and 17α-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.625 mg, and 1.25 mg strengths of conjugated estrogens.
PREMARIN 0.3 mg, 0.625 mg, and 1.25 mg tablets also contain the following non-medicinal ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, purified Water.
PREMARIN Tablets are available as :
0.3 mg (green) tablets in blister strips of 28;
0.625 mg (maroon) tablets in blister strips of 28;
1.25 mg (yellow) tablets in blister strips of 14.
The tablets come in different strengths and each strength tablet is a different color. The color ingredients are:
- 0.3 mg (green color tablet with “0.3” printed in white ink): hypromellose, quinoline yellow lake, macrogol, FD&C Blue No. 2, Indigo carmine aluminum lake, titanium dioxide, polysorbate 80. The white branding ink contains the following: titanium dioxide, purified water, isopropyl alcohol, propylene glycol, hypomellose.
- 0.625 mg (maroon color tablet with “0.625” printed in white ink): hypromellose, titanium dioxide, FD&C Red #40 aluminum lake, macrogol, FD&C Blue #2 aluminum lake. The white branding ink contains the following: titanium dioxide, purified water, isopropyl alcohol, propylene glycol, hypomellose
- 1.25 mg (yellow color tablet with “1.25” printed in black ink): hypromellose, titanium dioxide, quinoline yellow aluminum lake, macrogol, polysorbate, FD&C yellow #6 sunset yellow FCF aluminum lake. The black branding ink contains the following: purified water, iron oxide black, isopropyl alcohol, propylene glycol, hypromellose.
Control #: 177429
December 1, 2014