mucinex fast-max cold, flu and sore throat

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Labeler: rb health (us) llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name mucinex fast-max cold, flu and sore throat
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Labeler rb health (us) llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-237
Product ID 63824-237_29a6bda7-28bc-e34a-e063-6294a90a3432
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-10-01

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63824237
Hyphenated Format 63824-237

Supplemental Identifiers

RxCUI
1110988
UPC
0363824191201
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mucinex fast-max cold, flu and sore throat (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (63824-237-20) / 10 TABLET, COATED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (63824-237-21) / 10 TABLET, COATED in 1 BLISTER PACK
  • 4 POUCH in 1 CARTON (63824-237-44) / 2 TABLET, COATED in 1 POUCH (63824-237-72)
source: ndc

Packages (3)

63824-237-20 2 BLISTER PACK in 1 CARTON (63824-237-20) / 10 TABLET, COATED in 1 BLISTER PACK 63824-237-21 2 BLISTER PACK in 1 CARTON (63824-237-21) / 10 TABLET, COATED in 1 BLISTER PACK 63824-237-44 4 POUCH in 1 CARTON (63824-237-44) / 2 TABLET, COATED in 1 POUCH (63824-237-72)

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Mucinex Fast-Max Cold, Flu and Sore Throat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "29a6bda7-28bc-e34a-e063-6294a90a3432", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0363824191201"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1110988"], "spl_set_id": ["d7c18e95-8d7b-4550-9a20-fc704a114adb"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RB Health (US) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (63824-237-20)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "63824-237-20", "marketing_start_date": "20171001"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (63824-237-21)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "63824-237-21", "marketing_start_date": "20201001"}, {"sample": false, "description": "4 POUCH in 1 CARTON (63824-237-44)  / 2 TABLET, COATED in 1 POUCH (63824-237-72)", "package_ndc": "63824-237-44", "marketing_start_date": "20171220"}], "brand_name": "Mucinex Fast-Max Cold, Flu and Sore Throat", "product_id": "63824-237_29a6bda7-28bc-e34a-e063-6294a90a3432", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "63824-237", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucinex Fast-Max", "brand_name_suffix": "Cold, Flu and Sore Throat", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20171001", "listing_expiration_date": "20261231"}