Mucinex Children's Mighty Chews Cough Nighttime

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:57:17

Label at a glance#

ProductMucinex Childrens Mighty Chews Night Time Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, ACETAMINOPHEN
Label structure10 sections

Indications and uses

■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ sore throat ■ headache ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ runny nose ■ sneezing ■ temporarily reduces fever ■ controls cough to help the user get to sleep

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 162.5 mg

Dextromethorphan HBr 5 mg

Doxylamine succinate 3.125 mg

OTC - PURPOSE SECTION

Acetaminophen 162.5 mg................................................Pain reliever/fever reducer

Dextromethorphan HBr 5 mg.......................... ...............Cough suppressant
Doxylamine succinate 3.125 mg.................................................Antihistamine

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these common cold and flu symptoms:

■ minor aches and pains

■ sore throat

■ headache
■ cough due to minor throat and bronchial irritation as may occur with
the common cold or inhaled irritants
■ runny nose

■ sneezing
■ temporarily reduces fever
■ controls cough to help the user get to sleep

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage
may occur if:
■ adult takes more than 6 doses (24 chewable tablets) in 24 hours, which is
the maximum daily amount
■ child takes more than 5 doses (10 chewable tablets) in 24 hours, which is
the maximum daily amount
■ taken with other drugs containing acetaminophen
■ adult has 3 or more alcoholic drinks every day while using this product


Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
■ skin reddening ■ blisters ■ rash


If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days,
is accompanied or followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.


Do not use
■ to make a child sleepy
■ with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
■ if the user is 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
■ has liver disease
■ has a sodium-restricted diet
■ has glaucoma
■ has a breathing problem such as emphysema or chronic bronchitis
■ has difficulty in urination due to enlargement of the prostate gland
■ is a child with pain of arthritis

Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers

When using this product
■ do not use more than directed (see Overdose warning)
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect
■ avoid alcoholic beverages
■ use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
■ cough comes back or occurs with rash or headache that lasts. These could be
signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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


Keep out of reach of children.


Overdose warning: Taking more than the recommended dose (overdose) may
cause liver damage. In case of overdose, get medical help or contact a Poison
Control Center right away. Prompt medical attention is critical for adults as
well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions
■ do not take more than directed (see Overdose warning)
■ chew thoroughly before swallowing
■ dose every 4 hours or as directed by a doctor

adults and children 12 years
of age and over
4 chewable tablets every 4 hours, not to exceed
6 doses (24 chewable tablets) in any 24-hour period
children 6 to under 12 years
of age
2 chewable tablets every 4 hours, not to exceed
5 doses (10 chewable tablets) in any 24-hour period
children under 6 years of agedo not use

OTHER SAFETY INFORMATION

Other information
■ each chewable tablet contains: potassium 5 mg and sodium 13 mg
■ Store in a cool dry place at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid, corn syrup, ethylcellulose, FD&C blue no. 1, FD&C red no. 40,
flavor, glycerin, malic acid, maltodextrin, pectin, potassium sodium tartrate,
purified water, sodium chloride, sodium polymetaphosphate, sucralose,
sucrose, trisodium citrate (anhydrous)

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72854-085-16

Children's
Mucinex®

Cough Suppressant

Antihistamine

Acetaminophen 162.5 mg

Dextromethorphan HBr 5 mg

Doxylamine succinate 3.125 m

Age 6+

Mixed Berry Flavor

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2715863acetaminophen 162.5 MG / dextromethorphan HBr 5 MG / doxylamine succinate 3.125 MG Chewable TabletPSN5
2715863acetaminophen 162.5 MG / dextromethorphan hydrobromide 5 MG / doxylamine succinate 3.125 MG Chewable TabletSCD5
2715863APAP 162.5 MG / dextromethorphan hydrobromide 5 MG / doxylamine succinate 3.125 MG Chewable TabletSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix110824 331630172854-085-16 Label.jpg

DailyMed Product Concepts#

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-085-16Mucinex Childrens Mighty Chews Night Time Cold and Flu16 in 1 BOTTLETABLET, CHEWABLE165

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-08572854-085-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-11-26monthly-update2026-06-03 17:40:50
12025-01-29full-release2026-06-01 01:01:54

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 Mighty Chews Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC2ce31244-9c6c-b7dd-e063-6394a90a31a82026-05-13WarningsExact identifier
ndc (package): 72854-085-16
ndc (product): 72854-085
ndc11 (package): 72854008516
spl id: 51bad8ca-7226-ecef-e063-6394a90a8fc3
spl set id: 2ce31244-9c6c-b7dd-e063-6394a90a31a8

Reported adverse events (FAERS/openFDA)#

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