FDA.reportPublic FDA data

Giltuss Childrens Cough and Chest Congestion

Manufacturer
Dextrum Laboratories, Inc
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:37:58

Label at a glance#

ProductGiltuss Childrens Cough and Chest Congestion
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure11 sections

Label contents#

Full prescribing information#

Indication and usage section

INDICATIONS & USAGE SECTION

Indication and usage section

Not take more than 6 doses in any 24 hours period.

Use enclosed dosing cup. keep dosage cup for use with this product

ML=Milliliters

Children under 4 years, consult a doctor

Children 4 to under 6 years, 2.5 ml every 4 hours

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

Children 12 years and over, 10 ml every 4 hours

indicationindication

Active ingredient section

OTC - ACTIVE INGREDIENT SECTION

Active ingredient section

(in each 5 ml)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

activeactive

Active ingredient section

INACTIVE INGREDIENT SECTION

inactiveinactive

Inactive ingredient

Citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water and sucralose.

Purpose section

OTC - PURPOSE SECTION

purposepurpose

Purpose section

Cough suppressant

Expectorant

Warnings

WARNINGS SECTION

WarningWarning

Warnings

Do not use if you child is now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotional condition, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.

Keep out of reach of childrens section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep outKeep out

Keep out of reach of childrens section

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

Question section

OTC - QUESTIONS SECTION

questionquestion

Question section

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

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

Ask a doctor section

OTC - ASK DOCTOR SECTION

Ask a doctorAsk a doctor

Ask a doctor section

Ask a doctor before use if the child has

cough that occurs with much phlegm(mucus)

a breathing problem or persistent or chronic cough that lasts such as occurs with asthma.

stop use section

OTC - STOP USE SECTION

Stop useStop use

stop use section

Stop use ans ask doctor of pharmacist if the child has symptoms do not get better within 7 days or are accompanied by fever, cough comes back or is accompanied by fever rash or persistent headache.

Dosage and Administratiion section

DOSAGE & ADMINISTRATION SECTION

dosagedosage

Dosage and Administratiion section

Not take more than 6 doses in any 24 hours period.

Use enclosed dosing cup. keep dosage cup for use with this product

ML=Milliliters

Children under 4 years, consult a doctor

Children 4 to under 6 years, 2.5 ml every 4 hours

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

Children 12 years and over, 10 ml every 4 hours

Package Label. Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

panelpanel

Package Label. Principal Display Panel

G Children, ninos 4-12

Children's

Giltuss

Cough & Chest Congestion

Tos y Congestion de Pecho

Alcohol Free. Sugar Free. Dye Free. Non-Drowsy

Sin Alcohol. Sin Azucar. Sin Colorantes. No causa sueno.

COUGH & COLD, CHEST CONGESTION, LIQUIFIES

AND LOOSSEN PHLEGM AND MUCUS

TOS Y CATARRO, CONGESTION DE PECHO,

LIQUA Y SUELTA LA FLEMA Y EL MOCO

RASBERRY FLAVOIR.

SABOR A FRAMBUESA. 4 FL OZ (118 ml)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-019-04Giltuss Childrens Cough and Chest Congestion118 mL in 1 BOTTLE, PLASTICSOLUTION1181
65852-019-04Giltuss Childrens Cough and Chest Congestion1 in 1 CARTONSOLUTION11

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65852-01965852-019-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
METHYLPARABENA2I8C7HI9TIACT
CITRIC ACID2968PHW8QPIACT
PROPYLPARABENZ8IX2SC1OHIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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 Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc40802fb6-c1ec-d7b0-e063-6394a90ab4232025-10-06WarningsExact identifier
ndc (package): 65852-019-04
ndc (product): 65852-019
ndc11 (package): 65852001904
spl id: 40802fb6-c1ed-d7b0-e063-6394a90ab423
spl set id: 40802fb6-c1ec-d7b0-e063-6394a90ab423

Reported adverse events (FAERS/openFDA)#

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