Guaifenesin and Dextromethorphan HBr

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 and Dextromethorphan HBr
Generic name: GUAIFENESIN AND DEXTROMETHORPHAN HBR
Manufacturer: VESPYR BRANDS LLC
Product type: HUMAN OTC DRUG
SPL set ID: 1c8fbf40-17c1-4ee9-a2b9-ca4a08e08293
SPL ID: 161614f9-ae67-454a-bf7f-dfc6ec40f8de
Version: 5
Effective date: 2026-04-13
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:59:40

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 applno	ANDA	206941	derived:openfda.application_number
application number		ANDA206941	openfda.application_number
brand name		Guaifenesin and Dextromethorphan HBr	openfda.brand_name
generic name		GUAIFENESIN AND DEXTROMETHORPHAN HBR	openfda.generic_name
manufacturer name		VESPYR BRANDS LLC	openfda.manufacturer_name
ndc	package	71179-011-21	openfda.package_ndc
ndc	product	71179-011	openfda.product_ndc
ndc11	package	71179001121	derived:openfda.package_ndc
rxcui		1099074	openfda.rxcui
spl id		161614f9-ae67-454a-bf7f-dfc6ec40f8de	id
spl set id		1c8fbf40-17c1-4ee9-a2b9-ca4a08e08293	set_id
unii		9D2RTI9KYH	openfda.unii
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 use for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Reported adverse events (FAERS/openFDA)#

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