TUSSI PRES PEDIATRIC is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.
| Product ID | 52083-232_55722edd-8e94-4cb1-914d-5545ee17cb79 |
| NDC | 52083-232 |
| Product Type | Human Otc Drug |
| Proprietary Name | TUSSI PRES PEDIATRIC |
| Generic Name | Guaifenesin, Phenylephrine Hcl,dextromethorphan Hydrobromide |
| Dosage Form | Syrup |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-03-24 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | KRAMER NOVIS |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Active Ingredient Strength | 5 mg/5mL; mg/5mL; mg/5mL |
| Pharm Classes | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2011-03-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-24 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-01-21 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-03-24 |
| Marketing End Date | 2017-07-12 |
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-24 |
| Marketing End Date | 2017-07-12 |
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 75 mg/5mL |
| SPL SET ID: | b01a45df-3cea-4729-80c1-7f35b7f707f0 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 52083-232 | TUSSI PRES PEDIATRIC | GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE |
| 52083-653 | PRESGEN PEDIATRIC | GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE |