
USFDA APPLICATION NUMBER - 205474 / DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| GUAIFENESIN(UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) | GUAIFENESIN | 200mg in 5 |
| HYDROCODONE BITARTRATE(UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) | HYDROCODONE BITARTRATE | 2.5mg in 5 |
Inactive Ingredients
| Ingredient Name | Burke Therapeutics | Mission Pharmacal Company | NOVOTEC PHARMA LLC |
|---|---|---|---|
| CITRIC ACID MONOHYDRATE(2968PHW8QP) | |||
| D&C RED NO. 33(9DBA0SBB0L) | |||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||
| GLYCERIN(PDC6A3C0OX) | |||
| METHYLPARABEN(A2I8C7HI9T) | |||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||
| POTASSIUM CITRATE(EE90ONI6FF) | |||
| POTASSIUM SORBATE(1VPU26JZZ4) | |||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||
| PROPYLPARABEN(Z8IX2SC1OH) | |||
| SACCHARIN SODIUM(SB8ZUX40TY) | |||
| SODIUM CITRATE(1Q73Q2JULR) | |||
| SORBITOL(506T60A25R) | |||
| WATER(059QF0KO0R) |