mucinex fast-max severe congestion and cough (63824-193)

Drug Facts

Product Profile

Brand Name mucinex fast-max severe congestion and cough

Generic Name dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Labeler rb health (us) llc

Dosage Form TABLET, COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

RB Health (US) LLC

Identifiers & Regulatory

Product NDC 63824-193

Product ID 63824-193_29a6bda7-28b9-e34a-e063-6294a90a3432

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2013-03-15

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 63824193

Hyphenated Format 63824-193

Supplemental Identifiers

RxCUI

1372652

UNII

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 severe congestion and cough (source: ndc)

Generic Name dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
200 mg/1
5 mg/1

source: ndc

Packaging

2 BLISTER PACK in 1 CARTON (63824-193-21) / 10 TABLET, COATED in 1 BLISTER PACK

source: ndc

Packages (1)

63824-193-21 2 BLISTER PACK in 1 CARTON (63824-193-21) / 10 TABLET, COATED in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

Mucinex Fast-Max Severe Congestion and Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "29a6bda7-28b9-e34a-e063-6294a90a3432", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1372652"], "spl_set_id": ["3ff4c4ea-7628-4d2b-a6e9-d994c25baef4"], "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 (63824-193-21)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "63824-193-21", "marketing_start_date": "20201001"}], "brand_name": "Mucinex Fast-Max Severe Congestion and Cough", "product_id": "63824-193_29a6bda7-28b9-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": "63824-193", "generic_name": "Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine Hydrochloride", "labeler_name": "RB Health (US) LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucinex Fast-Max", "brand_name_suffix": "Severe Congestion and Cough", "active_ingredients": [{"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": "20130315", "listing_expiration_date": "20261231"}