BRONCOCHEM
BRONCOCHEM KIDS COLD and FLU
Approved
Approval ID
b6559fb9-2dea-49c0-a274-3e77741a0ffd
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-PHENYLEPHRINE HCl-GUAIFENESIN
PRODUCT DETAILS
NDC Product Code65131-109
Application NumberM
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMarch 23, 2025
Generic NameACETAMINOPHEN-PHENYLEPHRINE HCl-GUAIFENESIN
INGREDIENTS (20)
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 10 mL
Code: 04JA59TNSJ
Classification: ACTIB
GUAIFENESINActive
Quantity: 200 mg in 10 mL
Code: 495W7451VQ
Classification: ACTIB
PROPYLENE GLYCOLInactive
Quantity: 1.5 mL in 10 mL
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Quantity: 2.5 mL in 10 mL
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Quantity: 2 mL in 10 mL
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Quantity: 15 mg in 10 mL
Code: 96K6UQ3ZD4
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 20 mg in 10 mL
Code: 2968PHW8QP
Classification: IACT
DISODIUM HEDTAInactive
Quantity: 0.9 mg in 10 mL
Code: KME849MC7A
Classification: IACT
POVIDONE K90Inactive
Quantity: 100 mg in 10 mL
Code: RDH86HJV5Z
Classification: IACT
SODIUM CITRATEInactive
Quantity: 40 mg in 10 mL
Code: 1Q73Q2JULR
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6.25 mg in 10 mL
Code: 451W47IQ8X
Classification: IACT
HONEYInactive
Quantity: 100 mg in 10 mL
Code: Y9H1V576FH
Classification: IACT
PROPYL GALLATEInactive
Quantity: 1 mg in 10 mL
Code: 8D4SNN7V92
Classification: IACT
FD&C RED NO. 40Inactive
Quantity: 0.16 mg in 10 mL
Code: WZB9127XOA
Classification: IACT
ALOE VERA LEAFInactive
Quantity: 4 mg in 10 mL
Code: ZY81Z83H0X
Classification: IACT
METHYLPARABENInactive
Quantity: 10 mg in 10 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 1.5 mg in 10 mL
Code: Z8IX2SC1OH
Classification: IACT
RASPBERRYInactive
Quantity: 0.0048 mL in 10 mL
Code: 4N14V5R27W
Classification: IACT
WATERInactive
Quantity: 10 mL in 10 mL
Code: 059QF0KO0R
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 10 mL
Code: 362O9ITL9D
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 3/25/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/10/2017
WARNINGS SECTION
LOINC: 34071-1Updated: 4/10/2017
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 3/25/2025
OTC - ASK DOCTOR SECTION
LOINC: 50569-3Updated: 4/10/2017
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 4/10/2017
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 4/10/2017
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/10/2017
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 3/25/2025
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 4/10/2017
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 4/10/2017
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 4/10/2017
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/10/2017