| Product NDC: | 16477-136 |
| Proprietary Name: | Donatuss |
| Non Proprietary Name: | Dihydrocodeine Bitartrate, Phenylephrine Hydrochloride, Guaifenesin |
| Active Ingredient(s): | 7.5; 50; 7.5 mg/5mL; mg/5mL; mg/5mL & nbsp; Dihydrocodeine Bitartrate, Phenylephrine Hydrochloride, Guaifenesin |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SYRUP |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16477-136 |
| Labeler Name: | Laser Pharmaceuticals LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | |
| Marketing Category: | UNAPPROVED OTHER |
| Start Marketing Date: | 20091007 |
| Package NDC: | 16477-136-16 |
| Package Description: | 473 mL in 1 BOTTLE (16477-136-16) |
| NDC Code | 16477-136-16 |
| Proprietary Name | Donatuss |
| Package Description | 473 mL in 1 BOTTLE (16477-136-16) |
| Product NDC | 16477-136 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Dihydrocodeine Bitartrate, Phenylephrine Hydrochloride, Guaifenesin |
| Dosage Form Name | SYRUP |
| Route Name | ORAL |
| Start Marketing Date | 20091007 |
| Marketing Category Name | UNAPPROVED OTHER |
| Labeler Name | Laser Pharmaceuticals LLC |
| Substance Name | DIHYDROCODEINE BITARTRATE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Strength Number | 7.5; 50; 7.5 |
| Strength Unit | mg/5mL; mg/5mL; mg/5mL |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |