Label: MUCINEX CHILDRENS MIGHTY CHEWS COUGH DAYTIME AND NIGHTTIME COMBO PACK- dextromethorphan hbr and doxylamine succinate kit
- NDC Code(s): 72854-081-16, 72854-082-16, 72854-083-32
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 18, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
-
Uses
Mucinex Children's Mighty Chews Cough Daytime:
Uses temporarily relieves cough due to minor throat and bronchial irritation
as may occur with a coldMucinex 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
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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
tranquilizersWhen 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 machineryStop 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
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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 swallowingadults and children 12 years
of age and over2 chewable tablets every 4 hours, not to exceed
12 chewable tablets in any 24-hour periodchildren 6 to under 12 years
of age1 chewable tablet every 4 hours, not to exceed
6 chewable tablets in any 24-hour periodchildren under 6 years of age do not use - OTHER SAFETY INFORMATION
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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, sucroseMucinex 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUCINEX CHILDRENS MIGHTY CHEWS COUGH DAYTIME AND NIGHTTIME COMBO PACK
dextromethorphan hbr and doxylamine succinate kitProduct 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, chewableProduct 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 234mm 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, chewableProduct 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)