| NDC Code | 53345-013-01 |
|---|
| Package Description | 1 BAG in 1 BOX (53345-013-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG |
|---|
| Product NDC | 53345-013 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Nighttime Sinus Relief |
|---|
| Non-Proprietary Name | Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride |
|---|
| Dosage Form | CAPSULE, LIQUID FILLED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20130615 |
|---|
| Marketing Category Name | OTC MONOGRAPH FINAL |
|---|
| Application Number | part341 |
|---|
| Manufacturer | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. |
|---|
| Substance Name | ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
|---|
| Strength | 325; 6.25; 5 |
|---|
| Strength Unit | mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
|---|