NDC Code | 63824-212-64 |
Package Description | 1 BOTTLE in 1 CARTON (63824-212-64) / 118 mL in 1 BOTTLE |
Product NDC | 63824-212 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Childrens Delsym |
Proprietary Name Suffix | Cough Plus Cold Night Time |
Non-Proprietary Name | Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride |
Dosage Form | SOLUTION |
Usage | ORAL |
Start Marketing Date | 20130318 |
Marketing Category Name | OTC MONOGRAPH DRUG |
Application Number | M012 |
Manufacturer | RB Health (US) LLC |
Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
Strength | 325; 12.5; 5 |
Strength Unit | mg/10mL; mg/10mL; mg/10mL |
Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |