Mucinex® Children's

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:56:56

Label at a glance#

ProductMucinex Childrens Cough and Chest Congestion Mini-Melts Orange Creme
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 as may occur with a cold.

Dosage and administration

empty entire contents of packet onto tongue and swallow for best taste, do not chew granules do not give more than 6 doses in any 24-hour period dose as follows or as directed by a doctor Age Dose adults and Children 12 years of age and over 2 to 4 packets every 4 hours children 6 years to under 12 years of age 1 to 2 packets every 4 hours children 4 years to under 6 years of age 1 packet every 4 hours children un...

Storage and handling

each packet contains: magnesium 6 mg and sodium 3 mg phenylketonurics : contains phenylalanine 2 mg per packet store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each packet)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 as may occur with a cold.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not useif you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

OTC - WHEN USING SECTION

When using this product do not use more than directed

OTC - STOP USE SECTION

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

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

  • empty entire contents of packet onto tongue and swallow
  • for best taste, do not chew granules
  • do not give more than 6 doses in any 24-hour period
  • dose as follows or as directed by a doctor
AgeDose
adults and Children 12 years of age and over2 to 4 packets every 4 hours
children 6 years to under 12 years of age1 to 2 packets every 4 hours
children 4 years to under 6 years of age1 packet every 4 hours
children under 4 years of agedo not use

Other information

STORAGE AND HANDLING SECTION

  • each packet contains: magnesium 6 mgand sodium 3 mg
  • phenylketonurics: contains phenylalanine 2 mg per packet
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, creme flavor, magnesium stearate, microcrystalline cellulose, orange flavor, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate

Questions?

OTC - QUESTIONS SECTION

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 Germany

PRINCIPAL DISPLAY PANEL - 12 Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pediatrician Recommended*

NDC 63824-943-12

Mucinex®
children's

COUGH AND
CHEST CONGESTION

Dextromethorphan HBr 5 mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant

  • Controls Cough
  • Relieves Chest Congestion
  • Thins and Loosens Mucus

Ages
4 +years

Orange Crème
Flavor

12 GRANULE PACKETS

PRINCIPAL DISPLAY PANEL - 12 Packet Carton
PRINCIPAL DISPLAY PANEL - 12 Packet Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2122356dextromethorphan HBr 5 MG / guaiFENesin 100 MG Oral GranulesPSN3
2122356dextromethorphan hydrobromide 5 MG / guaifenesin 100 MG Oral GranulesSCD3

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-943-02Mucinex ChildrensCough and Chest Congestion Mini-Melts Orange Creme1 in 1 PACKETGRANULE13
63824-943-02Mucinex ChildrensCough and Chest Congestion Mini-Melts Orange Creme2 in 1 PACKAGEGRANULE23
63824-943-12Mucinex ChildrensCough and Chest Congestion Mini-Melts Orange Creme12 in 1 CARTONGRANULE123
63824-943-12Mucinex ChildrensCough and Chest Congestion Mini-Melts Orange Creme1 in 1 PACKETGRANULE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-943-12EA - Each63824-94397b3f153-04ba-4e67-9308-2a1324ff560212024-01-04

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-94363824-943-12, 63824-943-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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 Chest Congestion Mini-Melts Orange CremeDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC66543190-1d3d-4259-ae73-d366ecbf9e522026-05-12WarningsExact identifier
ndc (package): 63824-943-12
ndc (package): 63824-943-02
ndc (product): 63824-943
ndc11 (package): 63824094302
ndc11 (package): 63824094312
spl id: 51a4f960-294a-48c2-e063-6394a90a3ff2
spl set id: 66543190-1d3d-4259-ae73-d366ecbf9e52

Reported adverse events (FAERS/openFDA)#

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