Guaiasorb DM

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: Guaiasorb DM
Generic name: DEXTROMETHORPHAN HBR, GUAIFENESIN
Manufacturer: NuCare Pharmaceuticals, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 46a480c7-7092-b809-e063-6294a90a60cd
SPL ID: 46a4853c-c2a3-3a1a-e063-6294a90af402
Version: 1
Effective date: 2025-12-23
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:26:47

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Guaiasorb DM	openfda.brand_name
generic name		DEXTROMETHORPHAN HBR, GUAIFENESIN	openfda.generic_name
manufacturer name		NuCare Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	68071-3938-4	openfda.package_ndc
ndc	product	68071-3938	openfda.product_ndc
ndc11	package	68071393804	derived:openfda.package_ndc
rxcui		996520	openfda.rxcui
spl id		46a4853c-c2a3-3a1a-e063-6294a90af402	id
spl set id		46a480c7-7092-b809-e063-6294a90a60cd	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 if you are now taking 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. Ask a doctor before use if you have a cough with too much phlegm (mucus) a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema. Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache that lasts. These could be signs of a serious condition

Reported adverse events (FAERS/openFDA)#

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