| NDC Code | 69365-004-01 |
|---|
| Package Description | 1 BLISTER PACK in 1 CARTON (69365-004-01) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
|---|
| Product NDC | 69365-004 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Facol Cold And Flu Day And Night |
|---|
| Non-Proprietary Name | Acetaminphen, Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hbr, Diphenhydramine Hcl, Lac Color, Gardenia Blue |
|---|
| Dosage Form | CAPSULE, LIQUID FILLED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20150801 |
|---|
| Marketing Category Name | OTC MONOGRAPH DRUG |
|---|
| Application Number | M012 |
|---|
| Manufacturer | JW HOLDINGS |
|---|
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 200; 8; 18.75; 35; 5 |
|---|
| Strength Unit | mg/1; mg/1; mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
|---|