FDA.reportPublic FDA data

Mucinex® Children's Cough & Congestion

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-18
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:57:58

Label at a glance#

ProductMucinex Childrens Cough and Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion due to a cold stuffy nose

Dosage and administration

do not give more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Age Dose children 6 to under 12 years of age 10 mL every 4 hours children 4 to under 6 years of age 5 mL every 4 hours children under 4 years of age do not use

Storage and handling

each 5 mL contains: sodium 3 mg store at 20-25°C (68-77°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant
Phenylephrine HCl 2.5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • nasal congestion due to a cold
    • stuffy nose

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not usein 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.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

OTC - WHEN USING SECTION

When using this product do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not give more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
AgeDose
children 6 to under 12 years of age10 mL every 4 hours
children 4 to under 6 years of age5 mL every 4 hours
children under 4 years of agedo not use

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum

1 may contain this ingredient

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 201 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE SIZE

Pediatrician Recommended †

NDC 63824-947-11

Mucinex®
Children's

COUGH &
CONGESTION

Dextromethorphan HBr 5 mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant
Phenylephrine HCl 2.5 mg - Nasal Decongestant

  • Relieves Chest Congestion
  • Breaks up Mucus
  • Relieves Stuffy Nose
  • Controls Cough

Ages
4+
yrs

Very Berry
Flavor Liquid

6.8 FL OZ (201 mL)

PRINCIPAL DISPLAY PANEL - 201 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 201 mL Bottle Carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-947-112020-06-16C16284748780-19d75b9d0-d516-f424-e053-dadaa90a57ceMucinex® Children's Cough & Congestion
63824-947-112020-01-31C16284748780-19d75b9d0-d516-f424-e053-dadaa90a57ceMucinex® Children's Cough & Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-947-11Mucinex Childrens Cough and Congestion1 in 1 CARTONSUSPENSION17
63824-947-11Mucinex Childrens Cough and Congestion201 mL in 1 BOTTLESUSPENSION2017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-947-11ML - Milliliter63824-947580f6bd1-0a5f-4e6f-b8c6-cd01cfa4e66b12020-03-10

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-94763824-947-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
XANTHAN GUMTTV12P4NEEIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
Mucinex Childrens Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd9e5a8d7-814c-4ab1-bb05-e4cb9155978e2026-05-18WarningsExact identifier
ndc (package): 63824-947-11
ndc (product): 63824-947
ndc11 (package): 63824094711
spl id: 5219f3a4-ccd0-d4ae-e063-6294a90a26d2
spl set id: d9e5a8d7-814c-4ab1-bb05-e4cb9155978e

Reported adverse events (FAERS/openFDA)#

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