MedPath
FDA Approval

Phenohytro

January 12, 2021

HUMAN PRESCRIPTION DRUG LABEL

Scopolamine(0.0065 mg in 5 mL)
Atropine(0.0194 mg in 5 mL)
Phenobarbital(16.2 mg in 5 mL)
Hyoscyamine(0.1037 mg in 5 mL)

Manufacturing Establishments (1)

ATLANTIC BIOLOGICALS CORP.

ATLANTIC BIOLOGICALS CORP.

047437707

Products (1)

Phenohytro

17856-0123

ORAL

January 7, 2021

Code: 451IFR0GXBClass: ACTIBQuantity: 0.0065 mg in 5 mL
AtropineActive
Code: 03J5ZE7KA5Class: ACTIBQuantity: 0.0194 mg in 5 mL
Code: YQE403BP4DClass: ACTIBQuantity: 16.2 mg in 5 mL
GlycerinInactive
Code: PDC6A3C0OXClass: IACTQuantity: 1981 mg in 5 mL
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACTQuantity: 28.9 mg in 5 mL
WATERInactive
Code: 059QF0KO0RClass: IACTQuantity: 2119 mg in 5 mL
SucroseInactive
Code: C151H8M554Class: IACTQuantity: 289 mg in 5 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 407 mg in 5 mL
FD&C Yellow No. 5Inactive
Code: I753WB2F1MClass: IACTQuantity: 0.075 mg in 5 mL
SorbitolInactive
Code: 506T60A25RClass: IACTQuantity: 895 mg in 5 mL
FD&C Blue No. 1Inactive
Code: H3R47K3TBDClass: IACTQuantity: 0.005 mg in 5 mL
MintInactive
Code: FV98Z8GITPClass: IACTQuantity: 2 mg in 5 mL
Code: F2R8V82B84Class: ACTIBQuantity: 0.1037 mg in 5 mL
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