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#
Contacts and useful links#
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
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Mucinex Childrens Night Time Multi-Symptom Cold and Flu
- Acetaminophen, Dextromethorphan HBr, Triprolidine HCl
- TRIPROLIDINE HYDROCHLORIDE
- TRIPROLIDINE
- D&C YELLOW NO. 10
- GLYCERIN
- FD&C RED NO. 40
- WATER
- SODIUM BENZOATE
- AMMONIUM GLYCYRRHIZATE
- PROPYLENE GLYCOL
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- XANTHAN GUM
- SUCRALOSE
- ACETAMINOPHEN
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72854-063 | 72854-063-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TRIPROLIDINE HYDROCHLORIDE | YAN7R5L890 | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| SORBITOL | 506T60A25R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mucinex Childrens Night Time Multi-Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | Reckitt Benckiser LLC | 4ceda68e-c7ce-eb87-e063-6394a90a8ded | 2026-05-21 | Warnings | 72854-063-04 72854-063 72854006304 52564fbf-bee6-f4f6-e063-6294a90a5c8d 4ceda68e-c7ce-eb87-e063-6394a90a8ded |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

