
USFDA APPLICATION NUMBER - 205352 / DOSAGE - TABLET;ORAL - 25MG;220MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) | DIPHENHYDRAMINE HYDROCHLORIDE | 25mg |
| NAPROXEN SODIUM(UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) | NAPROXEN SODIUM | 220mg |
Inactive Ingredients
| Ingredient Name | Bayer HealthCare LLC. | L. Perrigo Company |
|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | ||
| CARNAUBA WAX(R12CBM0EIZ) | ||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | ||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||
| HYPROMELLOSES(3NXW29V3WO) | ||
| MAGNESIUM STEARATE(70097M6I30) | ||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||
| POVIDONE(FZ989GH94E) | ||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||
| TALC(7SEV7J4R1U) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||
| WATER(059QF0KO0R) |