Giltuss Childrens Allergy Plus

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 Allergy Plus
Generic name: CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: Dextrum Laboratories Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 3fa5220f-38bb-9ef6-e063-6294a90aeff8
SPL ID: 3fa5220f-38bc-9ef6-e063-6294a90aeff8
Version: 1
Effective date: 2025-09-25
Source export date: 2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:55:53

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Giltuss Childrens Allergy Plus	openfda.brand_name
generic name		CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Dextrum Laboratories Inc.	openfda.manufacturer_name
ndc	package	65852-018-04	openfda.package_ndc
ndc	product	65852-018	openfda.product_ndc
ndc11	package	65852001804	derived:openfda.package_ndc
rxcui		1363752	openfda.rxcui
spl id		3fa5220f-38bc-9ef6-e063-6294a90aeff8	id
spl set id		3fa5220f-38bb-9ef6-e063-6294a90aeff8	set_id
unii		9D2RTI9KYH	openfda.unii
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 Section Warnings Section Do not use to sedate a child or to makea child sleepy in a child who is taking a prescription monoamine oxidase inhibitor(MAOI)(certain drugs for depression, psychiatric, or emotional condition, or Parkingson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains a MAOI, ask a doctor or pharmacistbefore taking this products. Warning

Reported adverse events (FAERS/openFDA)#

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