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USFDA APPLICATION NUMBER - 21497 / DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| NITAZOXANIDE(UNII: SOA12P041N) (NITAZOXANIDE - UNII:SOA12P041N) | NITAZOXANIDE | 500mg |
Inactive Ingredients
| Ingredient Name | Romark Laboratories, L.C. | Avera McKennan Hospital |
|---|---|---|
| ANHYDROUS CITRIC ACID(XF417D3PSL) | ||
| CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311) | ||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||
| FD&C RED NO. 40(WZB9127XOA) | ||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||
| HYPROMELLOSES(3NXW29V3WO) | ||
| LECITHIN, SOYBEAN(1DI56QDM62) | ||
| MAGNESIUM STEARATE(70097M6I30) | ||
| MALTODEXTRIN(7CVR7L4A2D) | ||
| MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(461P5CJN6T) | ||
| POLYVINYL ALCOHOL(532B59J990) | ||
| SODIUM BENZOATE(OJ245FE5EU) | ||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||
| STARCH, CORN(O8232NY3SJ) | ||
| SUCROSE(C151H8M554) | ||
| TALC(7SEV7J4R1U) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||
| TRIACETIN(XHX3C3X673) | ||
| TRISODIUM CITRATE DIHYDRATE(B22547B95K) | ||
| XANTHAN GUM(TTV12P4NEE) |
