FDA.reportPublic FDA data

Childrens Mucinex

Manufacturer
Reckitt Benckiser LLC
Effective date
2013-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:39:11

Label at a glance#

ProductChildrens Mucinex Congestion and Cough
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 take 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 mL = milliliter Age Dose children 6 years to under 12 years 10 mL every 4 hours children 4 years to under 6 years 5 mL every 4 hours children under 4 years do not use

Storage and handling

each 5 mL contains: sodium 3 mg tamper evident: do not use if neckband on bottle cap is broken or missing store between 20-25°C (68-77°F) do not refrigerate dosing cup provided

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 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.

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

  • your child gets nervous, dizzy or sleepless
  • 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 illness.

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 take 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
  • mL = milliliter
AgeDose
children 6 years to under 12 years10 mL every 4 hours
children 4 years to under 6 years5 mL every 4 hours
children under 4 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 3 mg
  • tamper evident: do not use if neckband on bottle cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, 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: Reckitt Benckiser, Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 201 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-283-67

Children's
Mucinex®

Congestion
& Cough

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

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

Age 4+

Berrylicious
Flavor Liquid

6.8 FL OZ
(201 mL)

Principal Display Panel - 201 mL Bottle Carton
Principal Display Panel - 201 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-283-672023-08-31C16284748780-19d75b9d0-5776-f424-e053-dadaa90a57ceChildren's Mucinex® Congestion & Cough
63824-283-672020-01-31C16284748780-19d75b9d0-5776-f424-e053-dadaa90a57ceChildren's Mucinex® Congestion & Cough

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-283-67ML - Milliliter63824-2838af22d5c-d6c1-4b63-9c52-52979c6d2eb912013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH2
GuaifenesinACTIVE INGREDIENT495W7451VQ2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ2
DextromethorphanACTIVE MOIETY7355X3ROTS2
GuaifenesinACTIVE MOIETY495W7451VQ2
PhenylephrineACTIVE MOIETY1WS297W6MV2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL2
edetate disodiumINACTIVE INGREDIENT7FLD91C86K2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOA2
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
propyl gallateINACTIVE INGREDIENT8D4SNN7V922
propylene glycolINACTIVE INGREDIENT6DC9Q167V32
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU2
sorbitolINACTIVE INGREDIENT506T60A25R2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD42
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95K2
waterINACTIVE INGREDIENT059QF0KO0R2
xanthan gumINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-28363824-283-67

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
Guaifenesin495W7451VQACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
anhydrous citric acidXF417D3PSLIACT
edetate disodium7FLD91C86KIACT
FD&C red no. 40WZB9127XOAIACT
glycerinPDC6A3C0OXIACT
propylene glycol6DC9Q167V3IACT
propyl gallate8D4SNN7V92IACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
sorbitol506T60A25RIACT
sucralose96K6UQ3ZD4IACT
trisodium citrate dihydrateB22547B95KIACT
xanthan gumTTV12P4NEEIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 508 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR22 mgExact identifier — unii candidate
47 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KCREAM / TOPICAL2 mgExact identifier — unii candidate
47 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / PERINEURAL0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET / ORAL7 mgExact identifier — unii candidate
9 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KCAPSULE / ORAL35 mgExact identifier — unii candidate
47 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii candidate
44 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION / INTRAMUSCULAR3480 mgExact identifier — unii candidate
47 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sorbitolSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / ORAL7 mgExact identifier — unii candidate
61 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SPRAY / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii candidate
44 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / ORAL1200 mgExact identifier — unii candidate
47 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii candidate
61 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92OINTMENT / TOPICALNAExact identifier — unii candidate
9 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KTABLET / SUBLINGUAL51 mgExact identifier — unii candidate
47 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KGRANULE, FOR SUSPENSION / ORAL4950 mgExact identifier — unii candidate
47 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii candidate
28 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KTABLET, FILM COATED, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
47 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / INTRAMUSCULAR0.03 %w/vExact identifier — unii candidate
47 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii candidate
61 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
sorbitolSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii candidate
9 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAVENOUS772 mgExact identifier — unii candidate
61 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates

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
fbd4206f-339a-64f7-e053-6294a90ad3422944effa-49c0-49e0-9de6-80911e57fb7e2023-05-16WarningsExact identifier
spl set id: 2944effa-49c0-49e0-9de6-80911e57fb7e

Reported adverse events (FAERS/openFDA)#

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