MUCINEX CHILDRENS MIGHTY CHEWS COUGH DAYTIME AND NIGHTTIME COMBO PACK- dextromethorphan hbr and doxylamine succinate 
RB Health (US) LLC

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Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack

Drug Facts

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

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

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.

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 agedo not use

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)

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

NDC 72854-083-32

DAY & NIGHT MIGHTY CHEWS COUGH


Mucinex®Childrens
Dextromethorphan HBr – Cough Suppressant

Doxylamine succinate - Antihistamin

16 Chewable Tablets each

Label

Label

MUCINEX CHILDRENS MIGHTY CHEWS COUGH DAYTIME AND NIGHTTIME COMBO PACK 
dextromethorphan hbr and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-083
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72854-083-321 in 1 CARTON06/03/2024
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 16 
Part 21 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize234mm
FlavorBERRY (Mixed Berry) Imprint Code M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72854-081-1616 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/03/2024
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScoreno score
ShapeROUNDSize23mm
FlavorBERRY (Mixed Berry) Imprint Code M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72854-082-1616 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/03/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/03/2024
Labeler - RB Health (US) LLC (081049410)

Revised: 4/2024
Document Id: 16637d54-804a-d3ce-e063-6394a90aafc9
Set id: 16637d54-8049-d3ce-e063-6394a90aafc9
Version: 1
Effective Time: 20240418
 
RB Health (US) LLC