FDA.reportPublic FDA data

Childrens Giltuss Honey DM Cough

Manufacturer
Dextrum Laboratories Inc
Effective date
2025-09-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:05

Label at a glance#

ProductChildrens Giltuss Honey DM Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Dosage and administration

Dosage and administration Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product children under 4 years, consult a doctor children 6 to under 12 years, 5ml every 6-8 hours children 12 years and over, 10ml every 6-8 hours

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

in case ofin case ofin case of overdose, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE SECTION

children underchildren under

Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product

children under 4 years, consult a doctor

children 6 to under 12 years, 5ml every 6-8 hours

children 12 years and over, 10ml every 6-8 hours

OTC - ACTIVE INGREDIENT SECTION

active ingredientactive ingredientActive ingredient (in each 5ml)

Active Ingredients ( in each 5 mL)

Dextromethorphan15mg

purpose cough suppresant

WARNINGS SECTION

do not usedo not useDo not use if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fotdepression, psychriatic or emotional condition, orParkinso's desese), or for 2 weeksafter stoppings the MAOI drugs. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

OTC - STOP USE SECTION

Stop useStop useStop use and ask a doctorif the child has a cough that last more than 7 days, comes back or is accompanied byfever, rash or persistent headache. These could be signs of a serius condition.

OTC - PURPOSE SECTION

purposepurposePurpose section Cough Suppresant

OTC - ASK DOCTOR SECTION

Ask a doctorAsk a doctorAsk a doctor before use if the child has couhg that occurs with too muchmucus

a persistent or chronic cough such as occurs with sthma.

OTHER SAFETY INFORMATION

temporarytemporaryTemporarily relieves: cough due to minor thoroat and brochial irritation associated with the common cold or inhaled irritants

the intensity of coughing

The impulse to cough to help your child get to sleep

OTC - QUESTIONS SECTION

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

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

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

Dosage and administration

Do not take more than 4 doses in any 24 hours period Keep sosage cup for use with this product

children under 4 years, consult a doctor

children 6 to under 12 years, 5ml every 6-8 hours

children 12 years and over, 10ml every 6-8 hours

dosagedosage

Inactive ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Natural and artificial flavor, natural grade A Honey, Methylparaben, potassium Sorbate, propylene Glycol, propylparaben, purified water, sucralose

Inactive IngredientsInactive Ingredients

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children giltuss honey DM 4-12 chid Giltuss Honey DM panelchid Giltuss Honey DM panel

Alcohol Free

DYE free

Non Drowsy

Certified Honey

Honey Lemon Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN1
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCD1
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSY1
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-007-04Childrens Giltuss Honey DM Cough1 in 1 CARTONLIQUID11
65852-007-04Childrens Giltuss Honey DM Cough118 mL in 1 BOTTLE, PLASTICLIQUID1181

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
65852-00765852-007-04

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
POTASSIUM SORBATE1VPU26JZZ4IACT
HONEYY9H1V576FHIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCRALOSE96K6UQ3ZD4IACT
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
Childrens Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories Inc3effaf4b-28c3-6131-e063-6294a90a17ff2025-09-17WarningsExact identifier
ndc (package): 65852-007-04
ndc (product): 65852-007
ndc11 (package): 65852000704
spl id: 3effaf4b-28c4-6131-e063-6294a90a17ff
spl set id: 3effaf4b-28c3-6131-e063-6294a90a17ff

Reported adverse events (FAERS/openFDA)#

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