
USFDA APPLICATION NUMBER - 87003 / DOSAGE - TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| ACETAMINOPHEN(UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) | ACETAMINOPHEN | 325mg |
| OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570) | OXYCODONE HYDROCHLORIDE | 5mg |
Inactive Ingredients
| Ingredient Name | West-Ward Pharmaceuticals Corp. |
|---|---|
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |
| SILICON DIOXIDE(ETJ7Z6XBU4) | |
| STEARIC ACID(4ELV7Z65AP) |