MUCINEX CHILDRENS MIGHTY CHEWS COUGH NIGHTTIME- dextromethorphan hbr and doxylamine succinate tablet, chewable

Mucinex Childrens Mighty Chews Cough Nighttime by

Drug Labeling and Warnings

Mucinex Childrens Mighty Chews Cough Nighttime 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: 72854-082-16

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 COUGH NIGHTTIME 
dextromethorphan hbr and doxylamine succinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-082
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 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)
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)
GLYCERIN (UNII: PDC6A3C0OX)

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: 72854-082-16	16 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	06/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/03/2024

Labeler - RB Health (US) LLC (081049410)