| NDC Code | 50804-805-03 |
|---|
| Package Description | 2 BLISTER PACK in 1 CARTON (50804-805-03) > 12 TABLET, COATED in 1 BLISTER PACK |
|---|
| Product NDC | 50804-805 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Cold And Head Congestion Severe |
|---|
| Non-Proprietary Name | Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride |
|---|
| Dosage Form | TABLET, COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20160530 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | GoodSense |
|---|
| Substance Name | ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 325; 200; 5 |
|---|
| Strength Unit | mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC] |
|---|