MedPath
FDA Approval

BRONCOCHEM

March 23, 2025

HUMAN OTC DRUG LABEL

Dextromethorphan(30 mg in 5 mL)
Pyrilamine Maleate(50 mg in 5 mL)

Registrants (1)

Manufacturing Establishments (1)

LABORATORIO MAGNACHEM INTERNATIONAL SRL

LABORATORIO MAGNACHEM INTERNATIONAL SRL

LABORATORIO MAGNACHEM INTERNATIONAL SRL

871446100

Products (1)

BRONCOCHEM MAXIMUM COUGH NIGHT

65131-110

M

OTC Monograph Drug (C200263)

ORAL

March 23, 2025

SUGARCANEInactive
Code: 81H2R5AOH3Class: IACTQuantity: 2.65 mg in 5 mL
Code: 9D2RTI9KYHClass: ACTIBQuantity: 30 mg in 5 mL
Code: R35D29L3ZAClass: ACTIBQuantity: 50 mg in 5 mL
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACTQuantity: 10 mg in 5 mL
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACTQuantity: 0.25 mg in 5 mL
ORANGE OILInactive
Code: AKN3KSD11BClass: IACTQuantity: 0.833 mg in 5 mL
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHKClass: IACTQuantity: 5 mg in 5 mL
PROPYLPARABEN SODIUMInactive
Code: 625NNB0G9NClass: IACTQuantity: 1.5 mg in 5 mL
ALCOHOL 95%Inactive
Code: 7528N5H79BClass: IACTQuantity: 0.25 mL in 5 mL
SORBITOL SOLUTION 70%Inactive
Code: 8KW3E207O2Class: IACTQuantity: 0.083 mL in 5 mL
waterInactive
Code: 059QF0KO0RClass: IACTQuantity: 5 mL in 5 mL

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION


WARNINGS SECTION


OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - DO NOT USE SECTION

OTC - STOP USE SECTION


INACTIVE INGREDIENT SECTION


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