Childrens Giltuss Honey 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: Childrens Giltuss Honey Cough and Chest Congestion
Generic name: DEXTROMETHORPHAN HBR, GUAIFENESIN
Manufacturer: Dextrum Laboratories, Inc
Product type: HUMAN OTC DRUG
SPL set ID: 3f909bc2-eb84-a19d-e063-6294a90ae04e
SPL ID: 3f909bc2-eb85-a19d-e063-6294a90ae04e
Version: 1
Effective date: 2025-09-24
Source export date: 2026-10-27
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2eee27992d1f29d82f827fd5be42f1314ed39ce4c497af5d81435ac6656a0957/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:27:09

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		Childrens Giltuss Honey Cough and Chest Congestion	openfda.brand_name
generic name		DEXTROMETHORPHAN HBR, GUAIFENESIN	openfda.generic_name
manufacturer name		Dextrum Laboratories, Inc	openfda.manufacturer_name
ndc	package	65852-003-04	openfda.package_ndc
ndc	product	65852-003	openfda.product_ndc
ndc11	package	65852000304	derived:openfda.package_ndc
rxcui		996520	openfda.rxcui
spl id		3f909bc2-eb85-a19d-e063-6294a90ae04e	id
spl set id		3f909bc2-eb84-a19d-e063-6294a90ae04e	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 your child is 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 don’t know is your prescription drug contains and 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.