| NDC Code | 36800-575-02 |
| Package Description | 2 BLISTER PACK in 1 CARTON (36800-575-02) / 12 TABLET, COATED in 1 BLISTER PACK |
| Product NDC | 36800-575 |
| 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 | 20170630 |
| Marketing Category Name | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Manufacturer | TopCo Associates LLC |
| 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] |