NDC 65131-091

BRONCOCHEM MAXIMUM COUGH

Dextromethorphan Hbr-gyaifenesin

BRONCOCHEM MAXIMUM COUGH is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Laboratorio Magnachem International Srl. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

• Product ID: 65131-091_b4e75d5f-2f1c-4ea0-84f2-705fd4631199
• NDC: 65131-091
• Product Type: Human Otc Drug
• Proprietary Name: BRONCOCHEM MAXIMUM COUGH
• Generic Name: Dextromethorphan Hbr-gyaifenesin
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2016-12-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: LABORATORIO MAGNACHEM INTERNATIONAL SRL
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
• Active Ingredient Strength: 30 mg/10mL; mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65131-091-08

1 BOTTLE, PLASTIC in 1 BOX (65131-091-08) > 120 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2016-12-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65131-091-08 [65131009108]

BRONCOCHEM MAXIMUM COUGH SYRUP

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-12-30

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/10mL

OpenFDA Data

• SPL SET ID: 8aa32b2a-a8be-4f8d-9b1f-eb007bff8e65
• Manufacturer:
  • LABORATORIO MAGNACHEM INTERNATIONAL SRL
• UNII:
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1234473
• UPC Code:
  • 0805418091080