Mucinex Children's Mighty Chews Cough Nighttime

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-06-03 18:04:08

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each chewable tablet) Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg

OTC - PURPOSE SECTION

Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant Doxylamine succinate 6.25 mg.................................................Antihistamine

Uses

Uses

■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ■ controls cough to help you get to sleep ■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

Warnings

WARNINGS SECTION

Warnings Do not use ■ to make a child sleepy ■ 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 ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers When using this product ■ do not exceed recommended dosage ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions ■ take every 4 hours, or as directed by a doctor ■ chew thoroughly before swallowing ■ do not swallow whole 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 Label Information

INACTIVE INGREDIENT SECTION

Inactive ingredients anhydrous citric acid, corn syrup, 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)

Label Images#

Mucinex Childrens Mighty Chews Cough Nighttime 1
Mucinex Childrens Mighty Chews Cough Nighttime 1
Mucinex Childrens Mighty Chews Cough Nighttime 2
Mucinex Childrens Mighty Chews Cough Nighttime 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2683423dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable TabletPSN4
2683423dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable TabletSCD4
2683423dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Chewable TabletSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-082-16EA - Each72854-082b5efd3db-9d86-4ccc-b83f-94cce79b9c4b12024-08-12

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-08272854-082-16

Ingredients#

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each chewable tablet) Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant Doxylamine succinate 6.25 mg.................................................Antihistamine

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ■ controls cough to help you get to sleep ■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

WARNINGS SECTION

WARNINGS SECTION

Warnings Do not use ■ to make a child sleepy ■ 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 ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers When using this product ■ do not exceed recommended dosage ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions ■ take every 4 hours, or as directed by a doctor ■ chew thoroughly before swallowing ■ do not swallow whole 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 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 INGREDIENT SECTION

Inactive ingredients anhydrous citric acid, corn syrup, 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

OTC - QUESTIONS SECTION

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-05-27full-release2026-06-01 01:59:06
22026-05-13weekly-update2026-06-03 18:03:04