Guaifenesin

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: Guaifenesin
Generic name: GUAIFENESIN
Manufacturer: Reliable 1 Laboratories LLC
Product type: HUMAN OTC DRUG
SPL set ID: ae469d4f-91c4-cff0-e053-2995a90a0497
SPL ID: 2bc81e27-90e3-930d-e063-6394a90a699d
Version: 5
Effective date: 2025-01-15
Source export date: 2026-10-27
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2c7d3f7bcea1543046130e07dcbaf7eea5fb0ce23f7faa6458d1c6d80c3fa0c3/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:44:23

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Guaifenesin	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		Reliable 1 Laboratories LLC	openfda.manufacturer_name
ndc	package	69618-061-06	openfda.package_ndc
ndc	product	69618-061	openfda.product_ndc
ndc11	package	69618006106	derived:openfda.package_ndc
rxcui		359601	openfda.rxcui
spl id		2bc81e27-90e3-930d-e063-6394a90a699d	id
spl set id		ae469d4f-91c4-cff0-e053-2995a90a0497	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 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 then 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signes of serious illness.

Reported adverse events (FAERS/openFDA)#

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