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: Sportpharm LLC
Product type: HUMAN OTC DRUG
SPL set ID: 2f170b35-03a8-4d2e-a4ea-21cccf693d9e
SPL ID: 4b24f7df-db25-d428-e063-6394a90ae3ef
Version: 1
Effective date: 2026-02-18
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:26:36

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		Sportpharm LLC	openfda.manufacturer_name
ndc	package	85766-150-14	openfda.package_ndc
ndc	product	85766-150	openfda.product_ndc
ndc11	package	85766015014	derived:openfda.package_ndc
rxcui		1298324	openfda.rxcui
spl id		4b24f7df-db25-d428-e063-6394a90ae3ef	id
spl set id		2f170b35-03a8-4d2e-a4ea-21cccf693d9e	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.