GUAIFENESIN 400MG CAPLETS

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 400MG CAPLETS
Generic name: GUAIFENESIN
Manufacturer: Gendose Pharmaceuticals, LLC
Product type: HUMAN OTC DRUG
SPL set ID: e7b82ec7-ef23-50c1-e053-2a95a90a662f
SPL ID: 48032e44-d1b5-ea4d-e063-6394a90aba26
Version: 7
Effective date: 2026-01-10
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:55

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		GUAIFENESIN 400MG CAPLETS	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		Gendose Pharmaceuticals, LLC	openfda.manufacturer_name
ndc	package	77333-360-25	openfda.package_ndc
ndc	package	77333-360-10	openfda.package_ndc
ndc	product	77333-360	openfda.product_ndc
ndc11	package	77333036010	derived:openfda.package_ndc
ndc11	package	77333036025	derived:openfda.package_ndc
rxcui		359601	openfda.rxcui
spl id		48032e44-d1b5-ea4d-e063-6394a90aba26	id
spl set id		e7b82ec7-ef23-50c1-e053-2a95a90a662f	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 DOCTOR BEFORE USE IF YOU HAVE: PERSISTENT OR CHRONIC COUGH SUAH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS) COUGH ACCOMPANIED BY EXCESSIVE PHLEGM WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSAGE DO NOT USE FOR MORE THAN 7 DAYS STOP USE AND ASK A DOCTOR IS COUGH LASTS FOR MORE THAN 7 DAYS, RECURS, OR IS ACCOMPANIED BY FEVER, RASH, OR PERSISTENT HEADACHE. THESE COULD BE SIGNS OF A SERIOUS CONDITION. 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.