NDC 63824-517

Mucinex Fast-Max Cold, Flu and Sore Throat

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide

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

• Product ID: 63824-517_22af2733-9b97-47a4-a52e-20a9ec49a413
• NDC: 63824-517
• Product Type: Human Otc Drug
• Proprietary Name: Mucinex Fast-Max Cold, Flu and Sore Throat
• Generic Name: Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide
• Dosage Form: Tablet, 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: 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: 2020-12-31

Packaging

NDC 63824-517-01

2 BLISTER PACK in 1 CARTON (63824-517-01) > 10 TABLET, COATED in 1 BLISTER PACK

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

NDC SPL Data Element Entries

NDC 63824-517-01 [63824051701]

Mucinex Fast-Max Cold, Flu and Sore Throat TABLET, 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: 492b48ce-2d03-45b4-9af6-c3dd315b74f8
• Manufacturer:
  • Reckitt Benckiser LLC
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1110988

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

NDC	Brand Name	Generic Name
72854-127	Mucinex Fast-Max Cold, Flu and Sore Throat	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
63824-015	Mucinex Fast-Max Cold, Flu and Sore Throat	Mucinex Fast-Max Cold, Flu and Sore Throat
63824-237	Mucinex Fast-Max Cold, Flu and Sore Throat	Mucinex Fast-Max Cold, Flu and Sore Throat
63824-191	Mucinex Fast-Max Cold, Flu and Sore Throat	Mucinex Fast-Max Cold, Flu and Sore Throat
63824-591	Mucinex Fast-Max Cold, Flu and Sore Throat	Mucinex Fast-Max Cold, Flu and Sore Throat
63824-514	Mucinex Fast-Max	Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide
63824-517	Mucinex Fast-Max	Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide