 
                        | Product NDC: | 55312-384 | 
| Proprietary Name: | 12 hour cough relief | 
| Non Proprietary Name: | dextromethorphan polistirex | 
| Active Ingredient(s): | 30 mg/5mL & nbsp; dextromethorphan polistirex | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | SUSPENSION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 55312-384 | 
| Labeler Name: | Western Family Foods Inc | 
| Product Type: | HUMAN OTC DRUG | 
| FDA Application Number: | ANDA091135 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20120914 | 
| Package NDC: | 55312-384-21 | 
| Package Description: | 1 BOTTLE in 1 CARTON (55312-384-21) > 89 mL in 1 BOTTLE | 
| NDC Code | 55312-384-21 | 
| Proprietary Name | 12 hour cough relief | 
| Package Description | 1 BOTTLE in 1 CARTON (55312-384-21) > 89 mL in 1 BOTTLE | 
| Product NDC | 55312-384 | 
| Product Type Name | HUMAN OTC DRUG | 
| Non Proprietary Name | dextromethorphan polistirex | 
| Dosage Form Name | SUSPENSION | 
| Route Name | ORAL | 
| Start Marketing Date | 20120914 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Western Family Foods Inc | 
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE | 
| Strength Number | 30 | 
| Strength Unit | mg/5mL | 
| Pharmaceutical Classes |