MUCINEX CHILDRENS MIGHTY CHEWS NIGHT TIME COLD AND FLU- acetaminophen, dextromethorphan hbr and doxylamine succinate tablet, chewable

Mucinex Childrens Mighty Chews Night Time Cold and Flu by

Drug Labeling and Warnings

Mucinex Childrens Mighty Chews Night Time Cold and Flu by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg

PURPOSE

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
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.

KEEP OUT OF REACH OF CHILDREN

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

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

Inactive ingredients
anhydrous citric acid, corn syrup, FD&C blue no. 1, 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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

NDC: 72854-085-16

Children's
Mucinex®

Cough Suppressant

Antihistamine

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 m

Age 6+

Mixed Berry Flavor

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS MIGHTY CHEWS NIGHT TIME COLD AND FLU 
acetaminophen, dextromethorphan hbr and doxylamine succinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-085
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	3.125 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	162.5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PECTIN (UNII: 89NA02M4RX)
POTASSIUM SODIUM TARTRATE (UNII: QH257BPV3J)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MALIC ACID (UNII: 817L1N4CKP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
SUCROSE (UNII: C151H8M554)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B)

Product Characteristics
Color	purple	Score	no score
Shape	ROUND	Size	23mm
Flavor	BERRY (Mixed Berry)	Imprint Code	M
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-085-16	16 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	06/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2025

Labeler - RB Health (US) LLC (081049410)