FDA.reportPublic FDA data

Giltuss Honey Cough and Chest Congestion

Manufacturer
Dextrum Laboratories, Inc
Effective date
2025-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:06

Label at a glance#

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

Dosage and administration

Dosage Adults and childrens 12 years and over 10ml every 4 hours Children 6 to 12 years of age 5 ml every 4 hours Children 4 to under 6 years of age 2.5ml every 4 hous Children under 4 yeras of age Consult a doctor

Label contents#

Full prescribing information#

Indication and user panel

INDICATIONS & USAGE SECTION

indication an userindication an user

Indication and user section:

Do not take more than 6 doses in any 24-hours perio. use enclosed dosing cup

  • Keep dosage cup for use whit this product
  • ml= milliliters

Adults and childrens 12 years and over 10ml every 4 hours

Children 6 to 12 years of age 5 ml every 4 hours

Children 4 to under 6 years of age 2.5ml every 4 hous

Children under 4 yeras of age Consult a doctor

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

active ingredientactive ingredient

Acive Ingredient

In each 10 ml

Dextromethorphan HBr 20mg

Guafenesin 200mg

OTC - PURPOSE SECTION

purposepurpose

Purposes:

Sough suppresant

Expectorant

Warnings

WARNINGS AND PRECAUTIONS SECTION

WarningWarningWarnings

Do not use if you are now taking a prescription monoamine oxidase inhibidor (MAOI) (Certain drugs for depression, psychiatric or emotional conditions, or Parkinson's desease), or for two weeks after stopping the MAOI drug. If you do not know if you prescription drug constains an MAOI, ask a doctor or pharmacist before taking this product.

Keep out of the reach of the children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keepkeep

Keep out of the reach of the children:

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

Pregnant or breast feedings

OTC - PREGNANCY OR BREAST FEEDING SECTION

pregnantpregnant

If pregnant or breast-feeding, ask a health professioinal before use.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

dosagedosage

Dosage

Adults and childrens 12 years and over 10ml every 4 hours

Children 6 to 12 years of age 5 ml every 4 hours

Children 4 to under 6 years of age 2.5ml every 4 hous

Children under 4 yeras of age Consult a doctor

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

Inacyive ingredients

C arboxymethylcellulose sodium, citric acid, glycerin, natural and artificial flavor, , natural grade A honey, methylparaben, propylene glycol,

propylparaben, purified water, sucralose.

Question section

OTC - QUESTIONS SECTION

questionquestion

Questions or comments

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

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

Warnings

WARNINGS SECTION

Warnings:

Do not use if you are now taking a prescription monoamine oxidase inhibidor (MAOI) (Certain drugs for depression, psychiatric or emotional conditions, or Parkinson's desease), or for two weeks after stopping the MAOI drug. If you do not know if you prescription drug constains an MAOI, ask a doctor or pharmacist before taking this product.

WarningWarning

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal panelprincipal panel

Maximum strength. Maxima Concentracion

Alcohol Free

Dye free

Non-Drowsy

True source

Certified Honey

Giltuss Honey Cough % Chest Congestion

Tos y congestion de Pecho

cough and cold, chest Tos y catarro,

Congestion, liquifies Congestion de Pecho,

and loosens phlegm and mucus Licua y suelt LA FLEMA Y EL MOCO

Honey Lemon flavor. Sabor a Miel y limon 4FL OZ (118ml)

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
65852-005-04Giltuss Honey Cough and Chest Congestion118 mL in 1 BOTTLE, PLASTICLIQUID1181
65852-005-04Giltuss Honey Cough and Chest Congestion1 in 1 CARTONLIQUID11

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65852-00565852-005-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
GUAIFENESIN495W7451VQACTIB
PROPYLPARABENZ8IX2SC1OHIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SUCRALOSE96K6UQ3ZD4IACT
GLYCERINPDC6A3C0OXIACT
HONEYY9H1V576FHIACT
CITRIC ACID2968PHW8QPIACT

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 Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3ff240ba-90b2-4c17-e063-6394a90ac56f2025-09-29WarningsExact identifier
ndc (package): 65852-005-04
ndc (product): 65852-005
ndc11 (package): 65852000504
spl id: 3ff240ba-90b3-4c17-e063-6394a90ac56f
spl set id: 3ff240ba-90b2-4c17-e063-6394a90ac56f

Reported adverse events (FAERS/openFDA)#

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