Giltuss EX Expectorant

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: Giltuss EX Expectorant
Generic name: GUAIFENESIN
Manufacturer: Gil Pharmaceutical Corp
Product type: HUMAN OTC DRUG
SPL set ID: a8c53c14-ba82-2c68-e053-2a95a90a9894
SPL ID: 40b8ef34-8eeb-c72d-e063-6294a90aff26
Version: 6
Effective date: 2025-10-09
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:14:45

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		Giltuss EX Expectorant	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		Gil Pharmaceutical Corp	openfda.manufacturer_name
ndc	package	58552-145-04	openfda.package_ndc
ndc	product	58552-145	openfda.product_ndc
ndc11	package	58552014504	derived:openfda.package_ndc
rxcui		310625	openfda.rxcui
spl id		40b8ef34-8eeb-c72d-e063-6294a90aff26	id
spl set id		a8c53c14-ba82-2c68-e053-2a95a90a9894	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 cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding , ask a health 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.