Phenohytro
PHENOHYTRO ELIXIR
Approved
Approval ID
29be31ef-108e-4b45-9ecc-b6d671da2826
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2019
Manufacturers
FDA
Winder Laboratories LLC
DUNS: 965195170
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide
PRODUCT DETAILS
NDC Product Code75826-127
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateOctober 10, 2019
Generic NamePhenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide
INGREDIENTS (13)
Scopolamine HydrobromideActive
Quantity: 0.0065 mg in 5 mL
Code: 451IFR0GXB
Classification: ACTIB
PhenobarbitalActive
Quantity: 16.2 mg in 5 mL
Code: YQE403BP4D
Classification: ACTIB
Atropine sulfateActive
Quantity: 0.0194 mg in 5 mL
Code: 03J5ZE7KA5
Classification: ACTIB
GlycerinInactive
Quantity: 1981 mg in 5 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Quantity: 2119 mg in 5 mL
Code: 059QF0KO0R
Classification: IACT
SucroseInactive
Quantity: 289 mg in 5 mL
Code: C151H8M554
Classification: IACT
ALCOHOLInactive
Quantity: 407 mg in 5 mL
Code: 3K9958V90M
Classification: IACT
SACCHARIN SODIUMInactive
Quantity: 28.9 mg in 5 mL
Code: SB8ZUX40TY
Classification: IACT
SorbitolInactive
Quantity: 895 mg in 5 mL
Code: 506T60A25R
Classification: IACT
FD&C Red No. 3Inactive
Quantity: 0.075 mg in 5 mL
Code: PN2ZH5LOQY
Classification: IACT
FD&C Blue No. 1Inactive
Quantity: 0.005 mg in 5 mL
Code: H3R47K3TBD
Classification: IACT
GrapeInactive
Quantity: 2 mg in 5 mL
Code: 6X543N684K
Classification: IACT
Hyoscyamine SulfateActive
Quantity: 0.1037 mg in 5 mL
Code: F2R8V82B84
Classification: ACTIB
Phenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide
PRODUCT DETAILS
NDC Product Code75826-128
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateOctober 10, 2019
Generic NamePhenobarbital, Hyoscyamine Sulfate, Atropine sulfate, and Scopolamine Hydrobromide
INGREDIENTS (13)
PhenobarbitalActive
Quantity: 16.2 mg in 5 mL
Code: YQE403BP4D
Classification: ACTIB
Atropine sulfateActive
Quantity: 0.0194 mg in 5 mL
Code: 03J5ZE7KA5
Classification: ACTIB
Scopolamine HydrobromideActive
Quantity: 0.0065 mg in 5 mL
Code: 451IFR0GXB
Classification: ACTIB
GlycerinInactive
Quantity: 1981 mg in 5 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Quantity: 2119 mg in 5 mL
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Quantity: 407 mg in 5 mL
Code: 3K9958V90M
Classification: IACT
SucroseInactive
Quantity: 289 mg in 5 mL
Code: C151H8M554
Classification: IACT
SACCHARIN SODIUMInactive
Quantity: 28.9 mg in 5 mL
Code: SB8ZUX40TY
Classification: IACT
FD&C Blue No. 1Inactive
Quantity: 0.005 mg in 5 mL
Code: H3R47K3TBD
Classification: IACT
SorbitolInactive
Quantity: 895 mg in 5 mL
Code: 506T60A25R
Classification: IACT
FD&C Yellow No. 5Inactive
Quantity: 0.075 mg in 5 mL
Code: I753WB2F1M
Classification: IACT
MintInactive
Quantity: 2 mg in 5 mL
Code: FV98Z8GITP
Classification: IACT
Hyoscyamine SulfateActive
Quantity: 0.1037 mg in 5 mL
Code: F2R8V82B84
Classification: ACTIB