Giltuss Childrens Cough and Chest Congestion

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: Giltuss Childrens Cough and Chest Congestion
Generic name: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Manufacturer: Dextrum Laboratories, Inc
Product type: HUMAN OTC DRUG
SPL set ID: 40802fb6-c1ec-d7b0-e063-6394a90ab423
SPL ID: 40802fb6-c1ed-d7b0-e063-6394a90ab423
Version: 1
Effective date: 2025-10-06
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:37:11

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		Giltuss Childrens Cough and Chest Congestion	openfda.brand_name
generic name		DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	openfda.generic_name
manufacturer name		Dextrum Laboratories, Inc	openfda.manufacturer_name
ndc	package	65852-019-04	openfda.package_ndc
ndc	product	65852-019	openfda.product_ndc
ndc11	package	65852001904	derived:openfda.package_ndc
rxcui		996520	openfda.rxcui
spl id		40802fb6-c1ed-d7b0-e063-6394a90ab423	id
spl set id		40802fb6-c1ec-d7b0-e063-6394a90ab423	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 Warnings Do not use if you child is now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotional condition, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child prescription drug contains an MAOI ask a doctor or pharmacist before taking this product. Warning

Reported adverse events (FAERS/openFDA)#

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