Phenohytro
Phenohytro™ (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablets Rx Only
Approved
Approval ID
27c8baac-f8ce-46d8-8a0f-ff769dd408d9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2019
Manufacturers
FDA
Winder Laboratories, LLC
DUNS: 965195170
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
PRODUCT DETAILS
NDC Product Code75826-118
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateDecember 27, 2019
Generic NamePHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
INGREDIENTS (9)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ATROPINE SULFATEActive
Quantity: 0.0194 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
PHENOBARBITALActive
Quantity: 16.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SCOPOLAMINE HYDROBROMIDEActive
Quantity: 0.0065 mg in 1 1
Code: 451IFR0GXB
Classification: ACTIB
HYOSCYAMINE SULFATEActive
Quantity: 0.1037 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB