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: KESIN PHARMA CORPORATION
Product type: HUMAN OTC DRUG
SPL set ID: 365c01b7-a197-4876-85fc-42204f787e3a
SPL ID: 316ac9e6-8d03-f55a-e063-6294a90a8540
Version: 7
Effective date: 2025-03-28
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 01:37:59

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 · 17 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		KESIN PHARMA CORPORATION	openfda.manufacturer_name
ndc	package	81033-102-10	openfda.package_ndc
ndc	package	81033-102-52	openfda.package_ndc
ndc	package	81033-102-51	openfda.package_ndc
ndc	package	81033-102-05	openfda.package_ndc
ndc	product	81033-102	openfda.product_ndc
ndc11	package	81033010210	derived:openfda.package_ndc
ndc11	package	81033010252	derived:openfda.package_ndc
ndc11	package	81033010251	derived:openfda.package_ndc
ndc11	package	81033010205	derived:openfda.package_ndc
rxcui		310604	openfda.rxcui
spl id		316ac9e6-8d03-f55a-e063-6294a90a8540	id
spl set id		365c01b7-a197-4876-85fc-42204f787e3a	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 us 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 and ask a doctor if • cough lasts mor 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.

Reported adverse events (FAERS/openFDA)#

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