| Product NDC: | 65224-537 |
| Proprietary Name: | Pediatex TDM |
| Non Proprietary Name: | TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE |
| Active Ingredient(s): | 4; 10; .938 mg/mL; mg/mL; mg/mL & nbsp; TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | LIQUID |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 65224-537 |
| Labeler Name: | Pernix Therapeutics, LLC |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | part341 |
| Marketing Category: | OTC MONOGRAPH FINAL |
| Start Marketing Date: | 20110429 |
| Package NDC: | 65224-537-30 |
| Package Description: | 1 BOTTLE in 1 BOX (65224-537-30) > 30 mL in 1 BOTTLE |
| NDC Code | 65224-537-30 |
| Proprietary Name | Pediatex TDM |
| Package Description | 1 BOTTLE in 1 BOX (65224-537-30) > 30 mL in 1 BOTTLE |
| Product NDC | 65224-537 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE |
| Dosage Form Name | LIQUID |
| Route Name | ORAL |
| Start Marketing Date | 20110429 |
| Marketing Category Name | OTC MONOGRAPH FINAL |
| Labeler Name | Pernix Therapeutics, LLC |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE |
| Strength Number | 4; 10; .938 |
| Strength Unit | mg/mL; mg/mL; mg/mL |
| Pharmaceutical Classes |