FDA.reportPublic FDA data

Kids' Cough & Chest Congestion

Manufacturer
Genexa Inc.
Effective date
2026-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-29 01:03:46

Label at a glance#

ProductKids Cough and Chest Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 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.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • SHAKE WELL BEFORE EACH USE
  • 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
AgeDose
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

STORAGE AND HANDLING SECTION

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

agave syrup (organic), citric acid (natural), flavors (organic blueberry and natural), glycerin (natural), purified water, xylitol (natural)

OTC - QUESTIONS SECTION

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

*When compared to the ingredient profiles in the leading brands’ top-selling comparable products. (FRC 2025)

SHAKE WELL BEFORE EACH USE

DO NOT use if perforated band around the bottle or seal under the cap is disturbed or missing.

Distributed by: Genexa Inc.

Atlanta, GA 30324 | genexa.com

Made in the USA with globally sourced ingredients

NDC 69676-0106-9

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pediatrician Preferred #1 INGREDIENTS*

Genexa

CLEAN MEDICINE

Ages 4-11

Kids DAYTIME Cough & Chest Congestion

Dextromethorphan HBr | Cough Suppressant

Guaifenesin | Expectorant

Cough, Mucus, Chest Congestion

0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens

Made with Real Agave + Blueberry flavoring

4 FL OZ (118 mL)

153A_Carton_R-20260421153A_Carton_R-20260421

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850015736018GTIN-13: 0850015736018
EAN-13: 0850015736018
GTIN-12: 850015736018
UPC-A: 850015736018
GTIN storage (14 digits): 00850015736018		153A_Carton_R-20260421.jpg

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
69676-010669676-0106-9

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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
AGAVE TEQUILANA JUICEGVG8G0207OIACT
WATER059QF0KO0RIACT
BLUEBERRY253RUG1X1AIACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCINEX INSTASOOTHE COUGHDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC0d99237c-0b52-0af6-e063-6394a90aba142026-08-03WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Mucinex Childrens Mighty Chews CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC155e07b3-0a08-3be8-e063-6394a90a76352026-05-31WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.a7ab2140-de09-158f-e053-2a95a90a25a02026-05-28WarningsName fallback
brand name: Kids Cough and Chest Congestion
Delsym CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCa43d59f9-3a6c-4a7c-b98d-b86d6035f7162026-05-27WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Cough Suppressant AdultDEXTROMETHORPHAN HYDROBROMIDERugby Laboratories47b713bd-4c1e-f44a-e063-6294a90a63d32026-05-25WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Nuvicare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDENUVICARE LLCec1d3dd6-2a8b-4487-81a2-be6313e976102026-03-24WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Gencare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEPIONEER LIFE SCIENCES, LLC7a02cbb6-c083-4d91-977b-9d53cb3e27842026-03-24WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Creomulsion For ChildrenDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d0e96c-1cc3-4961-e054-00144ff88e882026-02-17WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Creomulsion Cough Medicine Adult FormulaDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d07486-99b7-5c06-e054-00144ff8d46c2026-02-17WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Mixed Berry Sore Throat and Cough lozengeDEXTROMETHORPHAN HYDROBROMIDEMeijer Distribution, Inc.304ff4db-201a-60a4-e054-00144ff8d46c2026-02-02WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Goodmeds Non-Drowsy Cough ReliefDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.32482083-3f51-41f4-8d20-bedf143e066d2025-12-29WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
ROBITUSSIN LONG-ACTING COUGH Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLCf22248b7-7abd-4df7-a986-dae357ebe8f12025-11-25WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
BupropiDexDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.90cc9bcd-7891-4324-a1f4-f6df7a0457e02025-10-06WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
DextabsDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.71b567df-844a-4563-b85a-f4592233f37d2025-10-06WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
ValuMeds Cough Relief, Dextromethorphan HbrDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.b16a81db-d9bc-4cce-8ec2-dc189184931e2025-09-03WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Right Remedies Adult Long Lasting Cough Relief SoftgelDEXTROMETHORPHAN HYDROBROMIDEStrive Pharmaceuticals Inc.e3ea468e-4e12-4dae-b222-8e32456b77b82025-01-02WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEAdvanced Rx LLC297e10e3-e740-4434-91a2-2e5c54985d332025-01-01WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Long Acting Cough SoftgelsDEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INC322daee6-c61d-43d3-a54d-a354fd3df2422025-01-01WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE

Reported adverse events (FAERS/openFDA)#

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