Guaifenesin 400mg

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
Generic name: GUAIFENESIN
Manufacturer: Marlex Pharmaceuticals Inc
Product type: HUMAN OTC DRUG
SPL set ID: 13f4db4e-687e-9d7b-e063-6294a90ab088
SPL ID: 437e33ae-1e1d-56a8-e063-6294a90abc66
Version: 2
Effective date: 2025-11-13
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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Guaifenesin 400mg	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		Marlex Pharmaceuticals Inc	openfda.manufacturer_name
ndc	package	10135-790-60	openfda.package_ndc
ndc	package	10135-790-30	openfda.package_ndc
ndc	product	10135-790	openfda.product_ndc
ndc11	package	10135079060	derived:openfda.package_ndc
ndc11	package	10135079030	derived:openfda.package_ndc
rxcui		359601	openfda.rxcui
spl id		437e33ae-1e1d-56a8-e063-6294a90abc66	id
spl set id		13f4db4e-687e-9d7b-e063-6294a90ab088	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 by too much phlegm (mucus) Stop use and ask a doctor if cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. 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.