Donnatal
DONNATAL ELIXIR grape flavor 1 pint
Approved
Approval ID
faa67498-fdff-4fe7-9057-2045e9463c32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 2013
Manufacturers
FDA
PBM Pharmaceuticals Inc.
DUNS: 785470050
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PHENOBARBITAL ELIXIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66213-423
Product Classification
G
Generic Name
PHENOBARBITAL ELIXIR
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2013
FDA Product Classification
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
ALCOHOLInactive
Quantity: 0.4158 g in 5 mL
Code: 3K9958V90M
Classification: IACT
WATERInactive
Quantity: 2.1432 g in 5 mL
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 2.007 g in 5 mL
Code: PDC6A3C0OX
Classification: IACT
sucroseInactive
Quantity: .2925 g in 5 mL
Code: C151H8M554
Classification: IACT
saccharin sodiumInactive
Quantity: .02925 g in 5 mL
Code: SB8ZUX40TY
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GRAPEInactive
Quantity: 0.041 g in 5 mL
Code: 6X543N684K
Classification: IACT
FD&C Red No. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
sorbitolInactive
Quantity: .9068 g in 5 mL
Code: 506T60A25R
Classification: IACT
Hyoscyamine sulfateActive
Quantity: 0.1037 mg in 5 mL
Code: F2R8V82B84
Classification: ACTIB