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USFDA APPLICATION NUMBER - 19111 / DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| chlorpheniramine(UNII: 3U6IO1965U) (chlorpheniramine - UNII:3U6IO1965U) | chlorpheniramine | 8mg in 5 |
| hydrocodone(UNII: 6YKS4Y3WQ7) (hydrocodone - UNII:6YKS4Y3WQ7) | hydrocodone | 10mg in 5 |
Inactive Ingredients
| Ingredient Name | Kremers Urban Pharmaceuticals Inc. | UCB Inc. |
|---|---|---|
| ascorbic acid(PQ6CK8PD0R) | ||
| D&C Yellow No. 10(35SW5USQ3G) | ||
| ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62) | ||
| FD&C Yellow No. 6(H77VEI93A8) | ||
| high fructose corn syrup(XY6UN3QB6S) | ||
| methylparaben(A2I8C7HI9T) | ||
| polyethylene glycol 3350(G2M7P15E5P) | ||
| polysorbate 80(6OZP39ZG8H) | ||
| propylene glycol(6DC9Q167V3) | ||
| propylparaben(Z8IX2SC1OH) | ||
| STARCH, CORN(O8232NY3SJ) | ||
| sucrose(C151H8M554) | ||
| water(059QF0KO0R) | ||
| xanthan gum(TTV12P4NEE) |
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