FDA.reportPublic FDA data

Childrens Cough and Chest Congestion

Manufacturer
Genexa Inc.
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:42

Label at a glance#

ProductChildrens Cough and Chest Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 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

Purpose

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 - 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.

OVERDOSAGE SECTION

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

(1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 years

5 mL - 10 mL

every 4 hours

children 4 to under 6 years

2.5 mL - 5 mL

every 4 hours

children under 4 yearsdo not use

STORAGE AND HANDLING SECTION

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural citrus extract, flavor, purified water

OTC - QUESTIONS SECTION

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by PF CONSUMER HEALTHCARE 1 LLC, owner of the registered trademark Children's Robitussin® Cough & Chest Congestion DM.

SPL UNCLASSIFIED SECTION

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

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30318 | genexa.com

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC 69676-0070-9

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 4-11

Cough & Chest Congestion

Dextromethorphan HBr | Guaifenesin

Cough Suppressant - Expectorant

Mucus

Chest Congestion

Compare to active ingredients in Children's Robitussin® Cough & Chest Congestion DM*

How we're different

Made without: sodium benzoate, propylene glycol, sucralose & more!

Organic Blueberry Flavor

4 fl oz (118 mL) Dosing cup included

GNX-153_Cough-and-Chest-Congestion_Childrens_Carton_R-2022_01_14GNX-153_Cough-and-Chest-Congestion_Childrens_Carton_R-2022_01_14

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
69676-0070-9Childrens Cough and Chest Congestion118 mL in 1 BOTTLESUSPENSION1181
69676-0070-9Childrens Cough and Chest Congestion1 in 1 CARTONSUSPENSION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0070CHILDRENS COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) SUSPENSION [GENEXA INC.]1Current NDC, 2 package rows20250210_2d95d5a4-34dc-e195-e063-6394a90a39da.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-007069676-0070-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
AGAVE TEQUILANA JUICEGVG8G0207OIACT
WATER059QF0KO0RIACT
CITRUS FRUITXDK00Z8012IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
BLUEBERRY253RUG1X1AIACT
GUAIFENESIN495W7451VQACTIB

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 Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.2d95d5a4-34dc-e195-e063-6394a90a39da2025-02-07WarningsExact identifier
ndc (package): 69676-0070-9
ndc (product): 69676-0070
ndc11 (package): 69676007009
spl id: 2d95d5a4-34dd-e195-e063-6394a90a39da
spl set id: 2d95d5a4-34dc-e195-e063-6394a90a39da

Reported adverse events (FAERS/openFDA)#

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