BRONCOCHEM
BRONCOCHEM EXPECTORANT II
Approved
Approval ID
1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 23, 2025
Manufacturers
FDA
LABORATORIO MAGNACHEM INTERNATIONAL SRL
DUNS: 871446100
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl
PRODUCT DETAILS
NDC Product Code65131-011
Application NumberM
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMarch 23, 2025
Generic NameACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl
INGREDIENTS (16)
ACETAMINOPHENActive
Quantity: 325 mg in 10 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 20 mg in 10 mL
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 400 mg in 10 mL
Code: 495W7451VQ
Classification: ACTIB
SACCHARIN SODIUMInactive
Quantity: 40 mg in 10 mL
Code: SB8ZUX40TY
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 10 mL
Code: 04JA59TNSJ
Classification: ACTIM
SODIUM BENZOATEInactive
Quantity: 20 mg in 10 mL
Code: OJ245FE5EU
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 12 mg in 10 mL
Code: 451W47IQ8X
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Quantity: 6 mg in 10 mL
Code: 3VRD35U26C
Classification: IACT
DISODIUM HEDTAInactive
Quantity: 5 mg in 10 mL
Code: KME849MC7A
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 2 mg in 10 mL
Code: 2968PHW8QP
Classification: IACT
SORBITOLInactive
Quantity: 2.3 mL in 10 mL
Code: 506T60A25R
Classification: IACT
PROPYLENE GLYCOLInactive
Quantity: 2 mL in 10 mL
Code: 6DC9Q167V3
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.016 mL in 10 mL
Code: Q40Q9N063P
Classification: IACT
RASPBERRYInactive
Quantity: 0.006 mL in 10 mL
Code: 4N14V5R27W
Classification: IACT
FD&C RED NO. 40Inactive
Quantity: 0.29 mg in 10 mL
Code: WZB9127XOA
Classification: IACT
WATERInactive
Quantity: 10 mL in 10 mL
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 3/25/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 3/13/2025
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 3/17/2016
WARNINGS SECTION
LOINC: 34071-1Updated: 3/15/2016
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 3/13/2025
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 3/13/2025
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 3/15/2016
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 3/13/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 3/13/2025