Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
Approved
Approval ID
1b79a7d8-a8f4-4525-8b94-3e317fc5a717
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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
NDC Product Code63187-930
Application NumberANDA203375
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 1, 2022
Generic NameBrompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
INGREDIENTS (12)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
BROMPHENIRAMINE MALEATEActive
Quantity: 2 mg in 5 mL
Code: IXA7C9ZN03
Classification: ACTIB
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PSEUDOEPHEDRINE HYDROCHLORIDEActive
Quantity: 30 mg in 5 mL
Code: 6V9V2RYJ8N
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB