EXPECTORANT GUAIFENESIN EXTENDED-RELEASE

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: EXPECTORANT GUAIFENESIN EXTENDED-RELEASE
Generic name: GUAIFENESIN
Manufacturer: YET HEALTH GROUP LLC
Product type: HUMAN OTC DRUG
SPL set ID: f863ab35-046b-4006-901e-dd290c164acc
SPL ID: 0e127c48-e134-a961-e063-6394a90a3174
Version: 5
Effective date: 2024-01-03
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/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:23:44

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	213420	derived:openfda.application_number
application number		ANDA213420	openfda.application_number
brand name		EXPECTORANT GUAIFENESIN EXTENDED-RELEASE	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		YET HEALTH GROUP LLC	openfda.manufacturer_name
ndc	package	81179-007-04	openfda.package_ndc
ndc	product	81179-007	openfda.product_ndc
ndc11	package	81179000704	derived:openfda.package_ndc
rxcui		310621	openfda.rxcui
spl id		0e127c48-e134-a961-e063-6394a90a3174	id
spl set id		f863ab35-046b-4006-901e-dd290c164acc	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 professioal before use.

Reported adverse events (FAERS/openFDA)#

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