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: Ohm Laboratories, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 7076e42a-17ff-4c42-9963-2dc02c0a5e49
SPL ID: 4aa4fb35-6f33-6e33-e063-6394a90a495e
Version: 4
Effective date: 2026-02-12
Source export date: 2026-11-06
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/90742968499056f8845d54427ea2950526b02c3f289aedd40679ed8e120a0e89/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 08:44:59

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 · 24 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	209254	derived:openfda.application_number
application number		ANDA209254	openfda.application_number
brand name		Guaifenesin	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		Ohm Laboratories, Inc.	openfda.manufacturer_name
ndc	package	51660-567-86	openfda.package_ndc
ndc	package	51660-567-54	openfda.package_ndc
ndc	package	51660-566-41	openfda.package_ndc
ndc	package	51660-566-68	openfda.package_ndc
ndc	package	51660-567-58	openfda.package_ndc
ndc	package	51660-566-21	openfda.package_ndc
ndc	product	51660-566	openfda.product_ndc
ndc	product	51660-567	openfda.product_ndc
ndc11	package	51660056758	derived:openfda.package_ndc
ndc11	package	51660056641	derived:openfda.package_ndc
ndc11	package	51660056621	derived:openfda.package_ndc
ndc11	package	51660056786	derived:openfda.package_ndc
ndc11	package	51660056668	derived:openfda.package_ndc
ndc11	package	51660056754	derived:openfda.package_ndc
rxcui		636522	openfda.rxcui
rxcui		310621	openfda.rxcui
spl id		4aa4fb35-6f33-6e33-e063-6394a90a495e	id
spl set id		7076e42a-17ff-4c42-9963-2dc02c0a5e49	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 serious illness. If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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