Indications and uses
Uses ■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Mucinex Childrens Mighty Chews Cold and Flu
- Manufacturer
- RB Health (US) LLC
- Effective date
- 2025-01-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:54
Label at a glance#
ProductMucinex Childrens Mighty Chews Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Dosage and administration
Directions ■ take every 4 hours or as directed by a doctor ■ chew thoroughly before swallowing adults and children 12 years of age and over 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period children 6 to under 12 years of age 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period children under 6 years of age do not use
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Dextromethorphan HBr 10 mg
OTC - PURPOSE SECTION
Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant
Uses
Uses
■ temporarily relieves cough due to minor throat and bronchial irritation as
may occur with a cold
WARNINGS SECTION
Warnings
Do not use
■ if 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
■ a sodium-restricted diet
■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
■ cough that occurs with too much phlegm (mucus)
When using this product
■ do not exceed recommended dosage
Stop use and ask a doctor if
■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or
headache. 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. In case of overdose, get medical help or
contact a Poison Control Center right away
Directions
Directions
■ take every 4 hours or as directed by a doctor
■ chew thoroughly before swallowing
| adults and children 12 years
of age and over | 2 chewable tablets every 4 hours, not to exceed
12 chewable tablets in any 24-hour period |
| children 6 to under 12 years
of age | 1 chewable tablet every 4 hours, not to exceed
6 chewable tablets in any 24-hour period |
| children under 6 years of age | do not use |
OTHER SAFETY INFORMATION
Other information
■ each chewable tablet contains: potassium 5 mg and sodium 15 mg
■ store in a cool dry place at 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
anhydrous citric acid, corn syrup, FD&C red no. 40, flavors, glycerin, malic acid,
maltodextrin, pectin, potassium sodium tartrate, purified water, sodium chloride, trisodium citrate (anhydrous), sodium polymetaphosphate, sucralose, sucrose
OTC - QUESTIONS SECTION
Questions? 1-866-MUCINEX (1-866-682-4639)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 72854-084-016
Children's
Mucinex®
Cough Suppressant
Dextromethorphan HBr 5 mg
Age 6+
Mixed Berry Flavor
Chewable Tablets
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72854-084-16 | Mucinex Childrens Mighty Chews Cold and Flu | 16 in 1 BOTTLE | TABLET, CHEWABLE | 16 | 1 |
Products#
Every source-derived product name is available through these pages.
- Mucinex Childrens Mighty Chews Cold and Flu
- Acetaminophen and Dextromethorphan Hydrobromide
- ACETAMINOPHEN
- ETHYLCELLULOSE
- CORN SYRUP
- GLYCERIN
- WATER
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PECTIN
- POTASSIUM SODIUM TARTRATE
- SUCROSE
- ANHYDROUS CITRIC ACID
- ANHYDROUS TRISODIUM CITRATE
- SUCRALOSE
- MALIC ACID
- MALTODEXTRIN
- SODIUM CHLORIDE
- SODIUM POLYMETAPHOSPHATE
- FD&C RED NO. 40
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72854-084 | 72854-084-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 Mighty Chews Cold and Flu | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | RB Health (US) LLC | 2ce20ab5-5f2d-1c97-e063-6394a90ad67b | 2025-01-29 | Warnings | 72854-084-16 72854-084 72854008416 2ce1fc99-1f89-adb8-e063-6394a90a53a1 2ce20ab5-5f2d-1c97-e063-6394a90ad67b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.