MUCINEX CHILDRENS MIGHTY CHEWS COUGH DAYTIME AND NIGHTTIME COMBO PACK- dextromethorphan hbr and doxylamine succinate kit

Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack by

Drug Labeling and Warnings

Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack 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

Mucinex Children's Mighty Chews Cough Daytime:

Active ingredient (in each chewable tablet)
Dextromethorphan HBr 10 mg.

Mucinex Children's Mighty Chews Cough Nighttime:

Active ingredient (in each chewable tablet)
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg

PURPOSE

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

Uses

Mucinex Children's Mighty Chews Cough Daytime:

Uses temporarily relieves cough due to minor throat and bronchial irritation
as may occur with a cold

Mucinex Children's Mighty Chews Cough Nighttime:

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

Mucinex Children's Mighty Chews Cough Daytime:

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

■ cough that occurs with too much phlegm (mucus)
■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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.

Mucinex Children's Mighty Chews Cough Nighttime:

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

■ marked drowsiness may occur

■ exciteability may ocur, especial in chidren
■ 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

Directions

Mucinex Children's Mighty Chews Cough Daytime+Mucinex Children's Mighty Chews Cough Nighttime::

■ 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

Mucinex Children's Mighty Chews Cough Daytime:

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

Mucinex Children's Mighty Chews Cough Nighttime:

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: 72854-083-32

DAY & NIGHT MIGHTY CHEWS COUGH

Mucinex®Childrens
Dextromethorphan HBr – Cough Suppressant

Doxylamine succinate - Antihistamin

16 Chewable Tablets each

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS MIGHTY CHEWS COUGH DAYTIME AND NIGHTTIME COMBO PACK 
dextromethorphan hbr and doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-083

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-083-32	1 in 1 CARTON	06/03/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	16
Part 2	1 BOTTLE	16

Part 1 of 2

MUCINEX CHILDRENS MIGHTY CHEWS COUGH 
dextromethorphan hydrobromide tablet, chewable

Product Information
Item Code (Source)	NDC: 72854-081
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

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

Product Characteristics
Color	red	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: 72854-081-16	16 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

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

Part 2 of 2

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

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

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

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

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)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	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)