Giltuss Childrens Allergy Plus

Manufacturer
Dextrum Laboratories Inc.
Effective date
2025-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:46

Label at a glance#

ProductGiltuss Childrens Allergy Plus
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Dosage and administration

Dosage and administration section Not take more than 6 doses in any 24-hour period Use enclosed dosing cup Keep dosage cup for use this product ML=Milliliter Children undre 6 years, consult the doctor Children 6 to under 12 years, 5 ml every 4 to 6 hours Adults and children 12 years and over, 10 ml every 4 to 6 hours

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients ( in each 5 mL) Purpose

Chlorpheniramine maleate, USP 2 mg ------------------Antihistamine

Dextromethorphan HBr, USP 10 mg -----------------------Cough supressant

Phenylephrine HCl, USP 5 mg -------------------------------Nasal decongestant

Inactive ingredientsInactive ingredients

indication and usage section

INDICATIONS & USAGE SECTION

indication and usage section

Not take more than 6 doses in any 24-hour period

Use enclosed dosing cup

Keep dosage cup for use this product

ML=Milliliter

Children undre 6 years, consult the doctor

Children 6 to under 12 years, 5 ml every 4 to 6 hours

Adults and children 12 years and over, 10 ml every 4 to 6 hours

indicationindication

Keep out of reach of children section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children section

In case of overdose, get medical help or contact a Poison Control Center right away.

keepkeep

Inactive ingredient section

Inactive ingredient section

Citric acid, flavor, glycerin, metylparaben, propylparaben, purified water, and sucralose.

inactiveinactive

Purpose section

OTC - PURPOSE SECTION

Purpose section

Antihistamine

Cough Suppressant

Nasal Descongestant

purposepurpose

Question section

OTC - QUESTIONS SECTION

Question section

Call 1-787-848-9114, Monday-Friday 9AM-5PM EST.

Call your doctor for medical advice in the event of side effects

questionquestion

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.

WarningWarning

Dosage and administration section

DOSAGE & ADMINISTRATION SECTION

Dosage and administration section

Not take more than 6 doses in any 24-hour period

Use enclosed dosing cup

Keep dosage cup for use this product

ML=Milliliter

Children undre 6 years, consult the doctor

Children 6 to under 12 years, 5 ml every 4 to 6 hours

Adults and children 12 years and over, 10 ml every 4 to 6 hours

dosagedosage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal panelPrincipal panelPrincipal panel

Children 6-12

Children's Giltuss Allergy Plus

Cough & Congestion

Alcohol free, Sodium free, Sugar free,Dye free

Sneezing, runny nose, cough, itchy & watery eyes, sinus pressure, stuffy nose

Tutti Frutti flavor

4 floz ( 118 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN1
1363752chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD1
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
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e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-018-04Giltuss Childrens Allergy Plus1 in 1 CARTONSOLUTION11
65852-018-04Giltuss Childrens Allergy Plus118 mL in 1 BOTTLE, PLASTICSOLUTION1181

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65852-01865852-018-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa5220f-38bb-9ef6-e063-6294a90aeff82025-09-25WarningsExact identifier
ndc (package): 65852-018-04
ndc (product): 65852-018
ndc11 (package): 65852001804
spl id: 3fa5220f-38bc-9ef6-e063-6294a90aeff8
spl set id: 3fa5220f-38bb-9ef6-e063-6294a90aeff8

Reported adverse events (FAERS/openFDA)#

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