FDA.reportPublic FDA data

Kids Cough and Chest Congestion

Manufacturer
Genexa Inc.
Effective date
2023-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:52

Label at a glance#

ProductKids Cough and Chest Congestion
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Storage and handling

Other information store between 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

OTC - PURPOSE SECTION

Purposes

Cough suppressant

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use in a child who is 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 do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

SHAKE WELL BEFORE USING

  • do not give more than 6 doses in any 24-hour period
  • use only with enclosed dose cup. Do not use with any other dosing device.
  • mL = milliliter
children 6 to under 12 years5 mL - 10 mL every 4 hours
children 4 to under 6 years2.5 mL - 5 mL every 4 hours
children under 4 yearsdo not use

DIRECTIONS

RECENT MAJOR CHANGES SECTION

Added "SHAKE WELL BEFORE USING" under Directions

STORAGE AND HANDLING SECTION

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredientsorganic agave syrup, organic cherry flavor, natural citrus extract, natural flavor, purified water

OTC - QUESTIONS SECTION

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

SHAKE WELL before each use.

Bottle is safety sealed with a perforated band around the bottle. DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30068 | genexa.com

*This product is not manufactured or distributed by

GlaxoSmithKline Consumer Healthcare Holdings (US)

LLC, owner of the registered trademark Children’s

Robitussin® Cough & Chest Congestion DM.

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC 69676-0085-9

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa®

MEDICINE MADE CLEAN

Ages 4-11


Kids' Cough & Chest Congestion

Dextromethorphan HBr | Guaifenesin

Cough Suppressant - Expectorant

Cough

Mucus

Chest Congestion

Made with the same active ingredients as Children’s

Robitussin® Cough & Chest Congestion DM*

Medicine made clean

Same effective active ingredients,

but no artificial fillers.

Organic Cherry Flavor

4 FL OZ (118 mL)

Dosing cup included

Kids' Cough and Chest CongestionKids' Cough and Chest Congestion

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN1
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY1
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0085-92025-01-30C16284748780-12cef2736-aa00-d83d-e063-dadaa90ab31fKids' Cough & Chest Congestion Organic Cherry Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0085-9Kids Cough and Chest Congestion118 mL in 1 BOTTLE, PLASTICSOLUTION1181
69676-0085-9Kids Cough and Chest Congestion1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0085KIDS COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [GENEXA INC.]12 package rows20230811_0247cd44-fd97-72df-e063-6294a90a1e87.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-008569676-0085-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
AGAVE TEQUILANA STEMJ026JA743YIACT
WATER059QF0KO0RIACT
CITRUS FRUITXDK00Z8012IACT
GUAIFENESIN495W7451VQACTIB
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
0247cd44-fd98-72df-e063-6294a90a1e870247cd44-fd97-72df-e063-6294a90a1e872023-08-15WarningsExact identifier
spl id: 0247cd44-fd98-72df-e063-6294a90a1e87
spl set id: 0247cd44-fd97-72df-e063-6294a90a1e87

Reported adverse events (FAERS/openFDA)#

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