Childrens Giltuss Honey DM Cough

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 DM Cough
Generic name: DEXTROMETHORPHAN HBR
Manufacturer: Dextrum Laboratories Inc
Product type: HUMAN OTC DRUG
SPL set ID: 3effaf4b-28c3-6131-e063-6294a90a17ff
SPL ID: 3effaf4b-28c4-6131-e063-6294a90a17ff
Version: 1
Effective date: 2025-09-17
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 06:29:25

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Childrens Giltuss Honey DM Cough	openfda.brand_name
generic name		DEXTROMETHORPHAN HBR	openfda.generic_name
manufacturer name		Dextrum Laboratories Inc	openfda.manufacturer_name
ndc	package	65852-007-04	openfda.package_ndc
ndc	product	65852-007	openfda.product_ndc
ndc11	package	65852000704	derived:openfda.package_ndc
rxcui		1090496	openfda.rxcui
spl id		3effaf4b-28c4-6131-e063-6294a90a17ff	id
spl set id		3effaf4b-28c3-6131-e063-6294a90a17ff	set_id
unii		9D2RTI9KYH	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

Do not use if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fotdepression, psychriatic or emotional condition, orParkinso's desese), or for 2 weeksafter stoppings the MAOI drugs. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. do not use

Reported adverse events (FAERS/openFDA)#

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