Giltuss D

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 D
Generic name: GILTUSS D
Manufacturer: Dextrum Laboratories Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 3f17eefb-b625-b0f2-e063-6294a90afd4d
SPL ID: 3f17eefb-b626-b0f2-e063-6294a90afd4d
Version: 1
Effective date: 2025-09-18
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 06:28:01

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 D	openfda.brand_name
generic name		GILTUSS D	openfda.generic_name
manufacturer name		Dextrum Laboratories Inc.	openfda.manufacturer_name
ndc	package	65852-010-04	openfda.package_ndc
ndc	product	65852-010	openfda.product_ndc
ndc11	package	65852001004	derived:openfda.package_ndc
rxcui		2724415	openfda.rxcui
spl id		3f17eefb-b626-b0f2-e063-6294a90afd4d	id
spl set id		3f17eefb-b625-b0f2-e063-6294a90afd4d	set_id
unii		04JA59TNSJ	openfda.unii
unii		V1Q0O9OJ9Z	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 to sedate a child or to make a child sleepy, if you ar etaking a prescription monoamine oxidase inhibitor ( MAOI) ( certains 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. Warnings

Reported adverse events (FAERS/openFDA)#

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