Childrens Giltuss Honey Cough and Chest Congestion

Manufacturer
Dextrum Laboratories, Inc
Effective date
2025-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:37:57

Label at a glance#

ProductChildrens Giltuss Honey Cough and Chest Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure12 sections

Indications and uses

Uses Uses Temporary relieves: Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, the intensity of coughing , the impulse to cough to help your child get to sleep, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive

Dosage and administration

Directions Do 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 of age Consult a doctor children 4 to under 6 years of age 2.5 ml every 4 hours children 6 to under 12 years of age 5 ml every 4 hours Adults and children 12 years & over 10 ml every 4 hours

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients ( in Each 5 ml) Purposes

Dextromethorphan HBr, 10 mg ------------------------Cough Suppresant

Guaifenesin, 100 mg --------------------------------------Expectorant Active ingredientsActive ingredients

Uses

OTC - PURPOSE SECTION

Uses

Uses

Temporary relieves:

Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, the intensity of coughing , the impulse to cough to help your child get to sleep, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive UsesUses

warnings

WARNINGS SECTION

Warnings

Do not use

If your child is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you don’t know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product. warningwarning

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

Warnings

Ask a doctor before use if your child has, cough that occurs with too much phlegm (mucus) , a persistent or chronic cough as occurs with asthma. Ask a doctorAsk a doctor

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if

cough lasts for more than 7 days , come back, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition. Stop useStop use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately

Keep out of reach of childrenKeep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Do 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 of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

DirectionsDirections

Other information

OTHER SAFETY INFORMATION

Other information

Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS Other informationOther information

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

Carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water,sucralose Inactive ingredientsInactive ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments?

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

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

Indication and usage section

INDICATIONS & USAGE SECTION

Indication and usage section

Do 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 of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

indication and usageindication and usage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal panelPrincipal panelChildren 4-12

Alcohol free, Dye free, Non-drowsy

True source certified honey

Children's Giltuss Honey

Cough & Chest Congestion

Cough & cold, chest congestion, liquifies and loosen phlegm and mucus

Honey lemon flavor

4 floz 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
65852-003-04Childrens Giltuss Honey Cough and Chest Congestion1 in 1 CARTONSOLUTION11
65852-003-04Childrens Giltuss Honey Cough and Chest Congestion118 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
65852-00365852-003-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3f909bc2-eb84-a19d-e063-6294a90ae04e2025-09-24WarningsExact identifier
ndc (package): 65852-003-04
ndc (product): 65852-003
ndc11 (package): 65852000304
spl id: 3f909bc2-eb85-a19d-e063-6294a90ae04e
spl set id: 3f909bc2-eb84-a19d-e063-6294a90ae04e

Reported adverse events (FAERS/openFDA)#

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