good neighbor pharmacy childrens cold and cough
Amerisource Bergen Children’s Cough & Cold Drug Facts
Approved
Approval ID
cde0fd43-771f-4528-bad2-5727efec5250
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 17, 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.
brompheniramine maleate, dextromethorphan hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46122-813
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
brompheniramine maleate, dextromethorphan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (12)
BROMPHENIRAMINE MALEATEActive
Quantity: 2 mg in 10 mL
Code: IXA7C9ZN03
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 10 mL
Code: 9D2RTI9KYH
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/17/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 1/24/2025
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 1/24/2025
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 1/24/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 1/24/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 1/24/2025
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 4/17/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 1/24/2025
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 4/17/2025