
USFDA APPLICATION NUMBER - 88763 / DOSAGE - SYRUP;ORAL - 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| CODEINE PHOSPHATE(UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) | CODEINE PHOSPHATE | 10mg in 5 |
| PROMETHAZINE HYDROCHLORIDE(UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) | PROMETHAZINE HYDROCHLORIDE | 6.25mg in 5 |
Inactive Ingredients
| Ingredient Name | Actavis Mid Atlantic LLC | Bryant Ranch Prepack |
|---|---|---|
| CITRIC ACID MONOHYDRATE(2968PHW8QP) | ||
| CORN SYRUP(9G5L16BK6N) | ||
| D&C RED NO. 33(9DBA0SBB0L) | ||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||
| METHYLPARABEN(A2I8C7HI9T) | ||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||
| PROPYLPARABEN(Z8IX2SC1OH) | ||
| SACCHARIN SODIUM DIHYDRATE(SB8ZUX40TY) | ||
| SODIUM BENZOATE(OJ245FE5EU) | ||
| SODIUM CITRATE(1Q73Q2JULR) | ||
| WATER(059QF0KO0R) |