mucinex fast-max severe congestion and cough

Generic: guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name mucinex fast-max severe congestion and cough
Generic Name guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide
Labeler rb health (us) llc
Dosage Form TABLET, FILM 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 63824-515
Product ID 63824-515_0b76e5ce-b8a8-f2d5-e063-6394a90a1aa5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-08-01

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 63824515
Hyphenated Format 63824-515

Supplemental Identifiers

RxCUI
1372652
UPC
0363824193205
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 guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide (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
  • 4 BLISTER PACK in 1 CARTON (63824-515-20) / 5 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

63824-515-20 4 BLISTER PACK in 1 CARTON (63824-515-20) / 5 TABLET, FILM 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": "0b76e5ce-b8a8-f2d5-e063-6394a90a1aa5", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0363824193205"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1372652"], "spl_set_id": ["1991d5ee-fc90-4070-8965-cd6f4abc45cf"], "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": "4 BLISTER PACK in 1 CARTON (63824-515-20)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "63824-515-20", "marketing_start_date": "20240101"}], "brand_name": "Mucinex Fast-Max Severe Congestion and Cough", "product_id": "63824-515_0b76e5ce-b8a8-f2d5-e063-6394a90a1aa5", "dosage_form": "TABLET, FILM 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": "63824-515", "generic_name": "Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide", "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": "20180801", "listing_expiration_date": "20261231"}