RE-PB HYOS ELIXIR
Belladonna/Phenobarbital
Approved
Approval ID
4de8df82-23db-421b-8531-c755854b3e5e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BELLADONNA ALKALOIDS W/ PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-594
Product Classification
G
Generic Name
BELLADONNA ALKALOIDS W/ PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2009
FDA Product Classification
INGREDIENTS (11)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
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: 0.0065 mg in 5 mL
Code: 451IFR0GXB
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.1037 mg in 5 mL
Code: F2R8V82B84
Classification: ACTIB
Drug Labeling Information
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 10/20/2009
CLINICAL PHARMACOLOGY
This drug combination provides peripheral anticholinergic/antispasmodic action and mild sedation.