Mucinex Children's

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-06-03 18:04:05

Label at a glance#

ProductMucinex Childrens Night Time Multi-Symptom Cold and Flu
Active ingredientTRIPROLIDINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 10 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg

Triprolidine HCl 1.25 mg

OTC - PURPOSE SECTION

Acetaminophen 325 mg - Pain reliever/fever reducer
Dextromethorphan HBr 10 mg - Cough suppressant

Triprolidine HCl 1.25 mg.........................Antihistamine

INDICATIONS & USAGE SECTION

Uses
■ temporarily relieves these common cold and flu
symptoms:
■ cough ■ minor aches and pains ■ sore throat
■ headache ■ runny nose ■ sneezing
■ itching of the nose or throat
■ itchy, watery eyes due to hay fever
■ temporarily reduces fever
■ controls cough to help your child get to sleep

WARNINGS SECTION

Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if your child takes:
■ more than 4 doses (40 mL) in 24 hours, which is the
maximum daily amount for this product
■ with other drugs containing acetaminophen


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
■ with any other drug containing acetaminophen
(prescription or nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor
or pharmacist.
■ to make a child sleepy
■ 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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if the child has
■ liver disease ■ glaucoma
■ a breathing problem such as chronic bronchitis
■ persistent or chronic cough such as occurs with
asthma
■ cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is
■ 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
■ sedatives and tranquilizers may increase drowsiness


Stop use and ask a doctor if
■ pain or cough gets worse or lasts more than 5 days
■ 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.


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. Quick medical attention is critical for
children even if you do not notice any signs or
symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions
■ this product does not contain directions or
complete warnings for adult use
■ do not give more than directed (see Overdose warning)

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

OTHER SAFETY INFORMATION

■ each 10 mL contains: sodium 6 mg
■ store at 20-25ºC (68-77ºF)
■ do not refrigerate

INACTIVE INGREDIENT SECTION

Inactive ingredients
ammonium glycyrrhizate, anhydrous citric acid, edetate
disodium, FD&C red no. 40, FD&C yellow no. 10, flavors,
glycerin (soy), propylene glycol, purified water, sodium
benzoate, sorbitol, sucralose, xanthan gum

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

full carton labelfull carton label

back labelback label

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
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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
72854-06372854-063-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 Night Time Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4ceda68e-c7ce-eb87-e063-6394a90a8ded2026-05-21WarningsExact identifier
ndc (package): 72854-063-04
ndc (product): 72854-063
ndc11 (package): 72854006304
spl id: 52564fbf-bee6-f4f6-e063-6294a90a5c8d
spl set id: 4ceda68e-c7ce-eb87-e063-6394a90a8ded

Reported adverse events (FAERS/openFDA)#

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