FDA.reportPublic FDA data

Childrens Mucinex

Manufacturer
RB Health (US) LLC
Effective date
2022-02-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:07:00

Label at a glance#

ProductChildrens Mucinex Cough
Active ingredientDextromethorphan Hydrobromide, Guaifenesin
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

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 mL = milliliter Age Dose children 6 years to under 12 years 5 mL – 10 mL every 4 hours children 4 years to under 6 years 2.5 mL – 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

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

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

  • 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 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
  • mL = milliliter
AgeDose
children 6 years to under 12 years5 mL – 10 mL every 4 hours
children 4 years to under 6 years2.5 mL – 5 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 - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-286-64

Children's
Mucinex®

Cough

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Cough Suppressant
Expectorant

  • Cough
  • Chest Congestion
  • Breaks up Mucus
  • Alcohol-free

Age 4+

Cherry
Flavor Liquid

4 FL OZ
(118 mL)

Principal Display Panel - 118 mL Bottle Carton
Principal Display Panel - 118 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-286-642022-03-04C16284748780-19d75b9d0-5e42-f424-e053-dadaa90a57ceChildren's Mucinex® Cough
63824-286-642020-01-31C16284748780-19d75b9d0-5e42-f424-e053-dadaa90a57ceChildren's Mucinex® Cough

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-286-64ML - Milliliter63824-2866fb37eeb-032a-47b2-aba6-0117dd623d2812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH3
GuaifenesinACTIVE INGREDIENT495W7451VQ3
DextromethorphanACTIVE MOIETY7355X3ROTS3
GuaifenesinACTIVE MOIETY495W7451VQ3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL3
edetate disodiumINACTIVE INGREDIENT7FLD91C86K3
FD&C red No. 40INACTIVE INGREDIENTWZB9127XOA3
glycerinINACTIVE INGREDIENTPDC6A3C0OX3
propyl gallateINACTIVE INGREDIENT8D4SNN7V923
propylene glycolINACTIVE INGREDIENT6DC9Q167V33
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU3
sorbitolINACTIVE INGREDIENT506T60A25R3
sucraloseINACTIVE INGREDIENT96K6UQ3ZD43
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95K3
waterINACTIVE INGREDIENT059QF0KO0R3
xanthan gumINACTIVE INGREDIENTTTV12P4NEE3

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-28663824-286-64

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
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
Guaifenesin495W7451VQACTIB
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 DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, FILM COATED / ORAL0.04 mgExact identifier — unii candidate
9 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSPRAY, METERED / NASAL1.2 mg/1mlExact identifier — unii candidate
61 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / INTRAVENOUS0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii candidate
44 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSUSPENSION / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
47 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / OPHTHALMIC0.45 %w/vExact identifier — unii candidate
47 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii candidate
44 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAVENOUS772 mgExact identifier — unii candidate
61 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii candidate
29 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSPRAY / NASAL9 mgExact identifier — unii candidate
47 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KELIXIR / ORAL120 mgExact identifier — unii candidate
47 equally ranked IID candidates
FD&C red No. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLFILM / SUBLINGUAL11 mgExact identifier — unii candidate
61 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION, SOLUTION / INTRAMUSCULAR1188 mgExact identifier — unii candidate
47 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / INTRAMUSCULAR0.03 %w/vExact identifier — unii candidate
47 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / ORAL84 mgExact identifier — unii candidate
61 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii candidate
77 equally ranked IID candidates
FD&C red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii candidate
22 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION / INTRACARDIAC21 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRAVENOUS1276 mgExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact 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
24ec5cc3-2b8b-455e-b3ad-63717519166ca6c2fe13-543d-4bcb-b67b-540be01d78242022-02-25WarningsExact identifier
spl id: 24ec5cc3-2b8b-455e-b3ad-63717519166c
spl set id: a6c2fe13-543d-4bcb-b67b-540be01d7824

Reported adverse events (FAERS/openFDA)#

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