Mucinex

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Mucinex
Generic name: GUAIFENESIN
Manufacturer: Cardinal Health 107, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 8b0d6d01-f1dd-41b0-a71e-46668bc9cde6
SPL ID: 4bf12228-02c0-4ad2-9335-c57529ec6cf7
Version: 8
Effective date: 2026-05-12
Source export date: 2026-10-12
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:27:59

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	021282	derived:openfda.application_number
application number		NDA021282	openfda.application_number
brand name		Mucinex	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		Cardinal Health 107, LLC	openfda.manufacturer_name
ndc	package	55154-4680-0	openfda.package_ndc
ndc	product	55154-4680	openfda.product_ndc
ndc11	package	55154468000	derived:openfda.package_ndc
rxcui		636522	openfda.rxcui
rxcui		891301	openfda.rxcui
spl id		4bf12228-02c0-4ad2-9335-c57529ec6cf7	id
spl set id		8b0d6d01-f1dd-41b0-a71e-46668bc9cde6	set_id
unii		495W7451VQ	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use • for children under 12 years of age Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.