| NDC Code | 58596-002-10 |
|---|
| Package Description | 1 BLISTER PACK in 1 BOX (58596-002-10) > 10 TABLET in 1 BLISTER PACK (58596-002-01) |
|---|
| Product NDC | 58596-002 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Cold Medicine |
|---|
| Proprietary Name Suffix | Xl3 Forte |
|---|
| Non-Proprietary Name | Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20170801 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | Selgel M�xico, S.A. de C.V. |
|---|
| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 325; 4; 10 |
|---|
| Strength Unit | mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
|---|