NDC 65131-054

BRONCOCHEM KIDS COLD AND FLU

Acetaminophen-phenylephrine Hcl-guaifenesin

BRONCOCHEM KIDS COLD AND FLU 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; Phenylephrine Hydrochloride; Guaifenesin.

• Product ID: 65131-054_7ec85034-cc70-4465-bc25-9c700731eb02
• NDC: 65131-054
• Product Type: Human Otc Drug
• Proprietary Name: BRONCOCHEM KIDS COLD AND FLU
• Generic Name: Acetaminophen-phenylephrine Hcl-guaifenesin
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2017-05-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: LABORATORIO MAGNACHEM INTERNATIONAL SRL
• Substance Name: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
• Active Ingredient Strength: 325 mg/10mL; mg/10mL; mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65131-054-18

1 BOTTLE, PLASTIC in 1 BOX (65131-054-18) > 120 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2017-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65131-054-18 [65131005418]

BRONCOCHEM KIDS COLD AND FLU SYRUP

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-05-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/10mL

OpenFDA Data

• SPL SET ID: 523561fb-f6a7-4cde-9be2-bba02e60e208
• Manufacturer:
  • LABORATORIO MAGNACHEM INTERNATIONAL SRL
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1116568
• UPC Code:
  • 0805418098447