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USFDA APPLICATION NUMBER - 88763 / DOSAGE - SYRUP;ORAL - 10MG/5ML;6.25MG/5ML
| 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 | A-S Medication Solutions LLC | Amneal Pharmaceuticals LLC | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Lohxa | NuCare Pharmaceuticals,Inc. | Par Pharmaceutical | Pharmaceutical Associates, Inc. | Preferred Pharmaceuticals, Inc | Preferred Pharmaceuticals, Inc. | Proficient Rx LP | RPK Pharmaceuticals, Inc. | Sun Pharmaceutical Industries, Inc. | Actavis Mid Atlantic LLC | Bryant Ranch Prepack |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | ||||||||||||||
| ANHYDROUS CITRIC ACID(XF417D3PSL) | ||||||||||||||
| ASCORBIC ACID(PQ6CK8PD0R) | ||||||||||||||
| CITRIC ACID MONOHYDRATE(2968PHW8QP) | ||||||||||||||
| CORN SYRUP(9G5L16BK6N) | ||||||||||||||
| D&C RED NO. 33(9DBA0SBB0L) | ||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||||||
| EDETATE DISODIUM(7FLD91C86K) | ||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | ||||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||||||||||
| GLYCERIN(PDC6A3C0OX) | ||||||||||||||
| MENTHOL(L7T10EIP3A) | ||||||||||||||
| MENTHOL, UNSPECIFIED FORM(L7T10EIP3A) | ||||||||||||||
| METHYLPARABEN(A2I8C7HI9T) | ||||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||||||||||
| PROPYLPARABEN(Z8IX2SC1OH) | ||||||||||||||
| SACCHARIN SODIUM DIHYDRATE(SB8ZUX40TY) | ||||||||||||||
| SACCHARIN SODIUM(SB8ZUX40TY) | ||||||||||||||
| SACCHARIN(FST467XS7D) | ||||||||||||||
| SODIUM BENZOATE(OJ245FE5EU) | ||||||||||||||
| SODIUM CITRATE(1Q73Q2JULR) | ||||||||||||||
| SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR) | ||||||||||||||
| SODIUM PROPIONATE ANHYDROUS(391O0PO49R) | ||||||||||||||
| SORBITOL(506T60A25R) | ||||||||||||||
| SUCRALOSE(96K6UQ3ZD4) | ||||||||||||||
| SUCROSE(C151H8M554) | ||||||||||||||
| TRISODIUM CITRATE DIHYDRATE(B22547B95K) | ||||||||||||||
| WATER(059QF0KO0R) |
