MUCINEX CHILDRENS MIGHTY CHEWS COLD AND FLU- acetaminophen and dextromethorphan hydrobromide tablet, chewable

Drug Facts
ACTIVE INGREDIENT

Dextromethorphan HBr 10 mg
PURPOSE

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

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.
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

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

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
QUESTIONS

Questions? 1-866-MUCINEX (1-866-682-4639)
PRINCIPAL DISPLAY PANEL

NDC: 72854-084-016

Children's
Mucinex®

Cough Suppressant

Dextromethorphan HBr 5 mg

Age 6+

Mixed Berry Flavor

Chewable Tablets

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS MIGHTY CHEWS COLD AND FLU
acetaminophen and dextromethorphan hydrobromide tablet, chewable

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	162.5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 72854-084-16	16 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2025

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

Labeler - RB Health (US) LLC (081049410)

Mucinex Childrens Mighty Chews Cold and Flu by