SIMPEX 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: SIMPEX Guaifenesin
Generic name: GUAIFENESIN
Manufacturer: Simpex Pharma Pvt. Ltd
Product type: HUMAN OTC DRUG
SPL set ID: 1594f9d6-0c48-42bf-b76b-d621f215179a
SPL ID: 0b586737-4616-db6e-e063-6294a90a6135
Version: 5
Effective date: 2023-11-29
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:24:35

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		SIMPEX Guaifenesin	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		Simpex Pharma Pvt. Ltd	openfda.manufacturer_name
ndc	package	76457-004-00	openfda.package_ndc
ndc	product	76457-004	openfda.product_ndc
ndc11	package	76457000400	derived:openfda.package_ndc
rxcui		359601	openfda.rxcui
spl id		0b586737-4616-db6e-e063-6294a90a6135	id
spl set id		1594f9d6-0c48-42bf-b76b-d621f215179a	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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied with excessive phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache.These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care 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.