 
                        | Product NDC: | 54868-5853 | 
| Proprietary Name: | Mucinex DM | 
| Non Proprietary Name: | Guaifenesin and Dextromethorphan Hydrobromide | 
| Active Ingredient(s): | 30; 600 mg/1; mg/1 & nbsp; Guaifenesin and Dextromethorphan Hydrobromide | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, EXTENDED RELEASE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 54868-5853 | 
| Labeler Name: | Physicians Total Care, Inc. | 
| Product Type: | HUMAN OTC DRUG | 
| FDA Application Number: | NDA021620 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20080123 | 
| Package NDC: | 54868-5853-0 | 
| Package Description: | 2 BLISTER PACK in 1 CARTON (54868-5853-0) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 
| NDC Code | 54868-5853-0 | 
| Proprietary Name | Mucinex DM | 
| Package Description | 2 BLISTER PACK in 1 CARTON (54868-5853-0) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 
| Product NDC | 54868-5853 | 
| Product Type Name | HUMAN OTC DRUG | 
| Non Proprietary Name | Guaifenesin and Dextromethorphan Hydrobromide | 
| Dosage Form Name | TABLET, EXTENDED RELEASE | 
| Route Name | ORAL | 
| Start Marketing Date | 20080123 | 
| Marketing Category Name | NDA | 
| Labeler Name | Physicians Total Care, Inc. | 
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 
| Strength Number | 30; 600 | 
| Strength Unit | mg/1; mg/1 | 
| Pharmaceutical Classes |