BromfedDM
BROMFED DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg)
Approved
Approval ID
ccdf22f3-171f-4c19-8273-fefa140d1969
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 5, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6377
Application NumberANDA088811
Product Classification
M
Marketing Category
C73584
G
Generic Name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2013
FDA Product Classification
INGREDIENTS (12)
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
Brompheniramine MaleateActive
Quantity: 2 mg in 5 mL
Code: IXA7C9ZN03
Classification: ACTIB
Pseudoephedrine HydrochlorideActive
Quantity: 30 mg in 5 mL
Code: 6V9V2RYJ8N
Classification: ACTIB
Dextromethorphan HydrobromideActive
Quantity: 10 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
raw sugarInactive
Code: 8M707QY5GH
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT