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: American Health Packaging
Product type: HUMAN OTC DRUG
SPL set ID: 2fd702ea-3069-472c-b99e-c527f1375705
SPL ID: 24b1b6f4-c113-8adc-e063-6394a90a546c
Version: 1
Effective date: 2024-10-17
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:37:33

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 · 29 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		American Health Packaging	openfda.manufacturer_name
ndc	package	60687-874-16	openfda.package_ndc
ndc	package	60687-852-17	openfda.package_ndc
ndc	package	60687-863-48	openfda.package_ndc
ndc	package	60687-852-46	openfda.package_ndc
ndc	package	60687-863-42	openfda.package_ndc
ndc	package	60687-874-44	openfda.package_ndc
ndc	package	60687-852-40	openfda.package_ndc
ndc	package	60687-874-50	openfda.package_ndc
ndc	package	60687-863-56	openfda.package_ndc
ndc	product	60687-863	openfda.product_ndc
ndc	product	60687-874	openfda.product_ndc
ndc	product	60687-852	openfda.product_ndc
ndc11	package	60687087444	derived:openfda.package_ndc
ndc11	package	60687086356	derived:openfda.package_ndc
ndc11	package	60687087450	derived:openfda.package_ndc
ndc11	package	60687085240	derived:openfda.package_ndc
ndc11	package	60687085246	derived:openfda.package_ndc
ndc11	package	60687086342	derived:openfda.package_ndc
ndc11	package	60687086348	derived:openfda.package_ndc
ndc11	package	60687087416	derived:openfda.package_ndc
ndc11	package	60687085217	derived:openfda.package_ndc
rxcui		310604	openfda.rxcui
spl id		24b1b6f4-c113-8adc-e063-6394a90a546c	id
spl set id		2fd702ea-3069-472c-b99e-c527f1375705	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 cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. you are hypersensitive to any of the ingredients. 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.