
USFDA APPLICATION NUMBER - 22442 / DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| HYDROCODONE BITARTRATE(UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) | HYDROCODONE BITARTRATE | 5mg in 5 |
| PSEUDOEPHEDRINE HYDROCHLORIDE(UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) | PSEUDOEPHEDRINE HYDROCHLORIDE | 60mg in 5 |
Inactive Ingredients
| Ingredient Name | Hawthorn Pharmaceuticals, Inc. |
|---|---|
| ANHYDROUS CITRIC ACID(XF417D3PSL) | |
| GLYCERIN(PDC6A3C0OX) | |
| GRAPE(6X543N684K) | |
| METHYLPARABEN(A2I8C7HI9T) | |
| PROPYLENE GLYCOL(6DC9Q167V3) | |
| PROPYLPARABEN(Z8IX2SC1OH) | |
| SACCHARIN SODIUM(SB8ZUX40TY) | |
| SODIUM CITRATE(1Q73Q2JULR) | |
| SUCROSE(C151H8M554) | |
| WATER(059QF0KO0R) |