NDC 65131-116

BRONCOCHEM EXPECTORANT II

Acetaminophen-chlorpheniramine Maleate-dextromethorphan Hbr-guaifenesin-phenylephrine Hcl

BRONCOCHEM EXPECTORANT II is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Laboratorio Magnachem International Srl. The primary component is Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 65131-116_383c518a-2d0c-4346-894c-9e089094d612
• NDC: 65131-116
• Product Type: Human Otc Drug
• Proprietary Name: BRONCOCHEM EXPECTORANT II
• Generic Name: Acetaminophen-chlorpheniramine Maleate-dextromethorphan Hbr-guaifenesin-phenylephrine Hcl
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2016-12-30
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Labeler Name: LABORATORIO MAGNACHEM INTERNATIONAL SRL
• Substance Name: ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 250 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65131-116-87

1 BOTTLE, PLASTIC in 1 BOX (65131-116-87) > 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 65131-116-87 [65131011687]

BRONCOCHEM EXPECTORANT II SYRUP

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-12-30

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	250 mg/10mL

OpenFDA Data

• SPL SET ID: d0426469-9dd1-4bd1-b81e-69d33187daa2
• Manufacturer:
  • LABORATORIO MAGNACHEM INTERNATIONAL SRL
• UNII:
  • V1Q0O9OJ9Z
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1743369
• UPC Code:
  • 0805418116875