BRONCOCHEM
Broncochem Maximum Cough Night
Approved
Approval ID
dffdfa2c-a52e-4606-9b07-c8993e499f09
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.
DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65131-110
Application NumberM
Product Classification
M
Marketing Category
C200263
G
Generic Name
DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2025
FDA Product Classification
INGREDIENTS (11)
SUGARCANEInactive
Quantity: 2.65 mg in 5 mL
Code: 81H2R5AOH3
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
PYRILAMINE MALEATEActive
Quantity: 50 mg in 5 mL
Code: R35D29L3ZA
Classification: ACTIB
SODIUM BENZOATEInactive
Quantity: 10 mg in 5 mL
Code: OJ245FE5EU
Classification: IACT
FD&C YELLOW NO. 5Inactive
Quantity: 0.25 mg in 5 mL
Code: I753WB2F1M
Classification: IACT
ORANGE OILInactive
Quantity: 0.833 mg in 5 mL
Code: AKN3KSD11B
Classification: IACT
METHYLPARABEN SODIUMInactive
Quantity: 5 mg in 5 mL
Code: CR6K9C2NHK
Classification: IACT
PROPYLPARABEN SODIUMInactive
Quantity: 1.5 mg in 5 mL
Code: 625NNB0G9N
Classification: IACT
ALCOHOL 95%Inactive
Quantity: 0.25 mL in 5 mL
Code: 7528N5H79B
Classification: IACT
SORBITOL SOLUTION 70%Inactive
Quantity: 0.083 mL in 5 mL
Code: 8KW3E207O2
Classification: IACT
waterInactive
Quantity: 5 mL in 5 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: 4/22/2024
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 4/22/2024
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 1/15/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 3/13/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 4/22/2024
WARNINGS SECTION
LOINC: 34071-1Updated: 4/22/2024
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/22/2024
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 1/15/2024
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 4/22/2024
OTC - ASK DOCTOR/PHARMACIST SECTION
LOINC: 50568-5Updated: 4/22/2024