NDC 63824-515

Mucinex Fast-Max Severe Congestion and Cough

Guaifenesin, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide

Mucinex Fast-Max Severe Congestion and Cough is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Rb Health (us) Llc. The primary component is Guaifenesin; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

• Product ID: 63824-515_3bec5eb5-8c8a-486f-b4d2-84fd5b91f95a
• NDC: 63824-515
• Product Type: Human Otc Drug
• Proprietary Name: Mucinex Fast-Max Severe Congestion and Cough
• Generic Name: 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: RB Health (US) LLC
• Substance Name: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 200 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63824-515-01

2 BLISTER PACK in 1 CARTON (63824-515-01) > 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 63824-515-01 [63824051501]

Mucinex Fast-Max Severe Congestion and Cough 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
GUAIFENESIN	200 mg/1

OpenFDA Data

• SPL SET ID: 1991d5ee-fc90-4070-8965-cd6f4abc45cf
• Manufacturer:
  • Reckitt Benckiser LLC
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1372652

NDC Crossover Matching brand name "Mucinex Fast-Max Severe Congestion and Cough" or generic name "Guaifenesin, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
63824-193	Mucinex Fast-Max Severe Congestion and Cough	Mucinex Fast-Max Severe Congestion and Cough
63824-014	Mucinex Fast-Max Severe Congestion and Cough	Mucinex Fast-Max Severe Congestion and Cough
63824-540	Mucinex Fast-Max Severe Congestion and Cough	Mucinex Fast-Max Severe Congestion and Cough
58605-423	Maxiphen DM	Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide
63824-515	Mucinex Fast-Max	Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide