| NDC Code | 50991-510-01 |
|---|
| Package Description | 100 TABLET, FILM COATED in 1 BOTTLE (50991-510-01) |
|---|
| Product NDC | 50991-510 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Duraflu |
|---|
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Pseudoephedrine Hcl |
|---|
| Dosage Form | TABLET, FILM COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20110210 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | Poly Pharmaceuticals, Inc. |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|
| Strength | 500; 20; 200; 60 |
|---|
| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
|---|