PHENOBARBITAL WITH BELLADONNA ALKALOIDS
PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR
Approved
Approval ID
6186eca3-be71-48d6-b102-de15746f49e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2018
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PHENOBARBITAL WITH BELLADONNA ALKALOIDS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17856-0162
Product Classification
G
Generic Name
PHENOBARBITAL WITH BELLADONNA ALKALOIDS
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2018
FDA Product Classification
INGREDIENTS (13)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
REBAUDIOSIDE AInactive
Code: B3FUD0528F
Classification: IACT
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: .0065 mg in 5 mL
Code: 451IFR0GXB
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT
PROPYLPARABEN SODIUMInactive
Code: 625NNB0G9N
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.1037 mg in 5 mL
Code: F2R8V82B84
Classification: ACTIB