good neighbor pharmacy night time
Amerisource Bergen Night Time Drug Facts
Approved
Approval ID
e2b5c27e-ca5f-4503-a3ce-c86e1d8070a7
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 16, 2025
Manufacturers
FDA
Amerisource Bergen
DUNS: 007914906
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46122-136
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2025
FDA Product Classification
INGREDIENTS (13)
ACETAMINOPHENActive
Quantity: 650 mg in 30 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 30 mL
Code: 9D2RTI9KYH
Classification: ACTIB
DOXYLAMINE SUCCINATEActive
Quantity: 12.5 mg in 30 mL
Code: V9BI9B5YI2
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/16/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 5/13/2015
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 4/5/2016
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/9/2014
WARNINGS SECTION
LOINC: 34071-1Updated: 4/16/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 12/10/2018
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 8/4/2023
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 10/3/2012
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 8/4/2023