Cough Out

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: Cough Out
Generic name: GUAIFENESIN
Manufacturer: Efficient Laboratories Inc.
Product type: HUMAN OTC DRUG
SPL set ID: fe4c3921-8d30-4cd6-ba90-9211b362a38a
SPL ID: 37db956a-258a-9804-e063-6394a90aa2b4
Version: 9
Effective date: 2025-06-18
Source export date: 2026-10-27
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/2026-10-27/d7629e6f844435cfe6cb0cf8c5341c46775ea16c5af42c77a22a2ffe820a2cd2/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:49:31

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Cough Out	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		Efficient Laboratories Inc.	openfda.manufacturer_name
ndc	package	58593-255-04	openfda.package_ndc
ndc	package	58593-255-06	openfda.package_ndc
ndc	product	58593-255	openfda.product_ndc
ndc11	package	58593025504	derived:openfda.package_ndc
ndc11	package	58593025506	derived:openfda.package_ndc
rxcui		1099024	openfda.rxcui
rxcui		310604	openfda.rxcui
spl id		37db956a-258a-9804-e063-6394a90aa2b4	id
spl set id		fe4c3921-8d30-4cd6-ba90-9211b362a38a	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 exceed recommended dosage Ask a doctor before use if you have a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persstent headached. A persistent cough may be a sign of a serious condition.

Reported adverse events (FAERS/openFDA)#

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