NDC 63824-514

Mucinex Fast-Max Cold and Flu

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide

Mucinex Fast-Max Cold and Flu is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Reckitt Benckiser Llc. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

• Product ID: 63824-514_48691b69-8c5b-4088-a4c9-2942061154a7
• NDC: 63824-514
• Product Type: Human Otc Drug
• Proprietary Name: Mucinex Fast-Max Cold and Flu
• Generic Name: Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Reckitt Benckiser LLC
• Substance Name: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63824-514-01

2 BLISTER PACK in 1 CARTON (63824-514-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2018-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63824-514-01 [63824051401]

Mucinex Fast-Max Cold and Flu TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-08-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: c16253d3-3824-458c-8840-e3a2fbe7682c
• Manufacturer:
  • Reckitt Benckiser LLC
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1110988
• UPC Code:
  • 0363824192208

NDC Crossover Matching brand name "Mucinex Fast-Max Cold and Flu" or generic name "Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
72854-126	Mucinex Fast-Max Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
63824-514	Mucinex Fast-Max	Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide
63824-517	Mucinex Fast-Max	Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide