Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack is an FDA drug label for the active ingredient DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE manufactured by Reckitt Benckiser LLC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260527.
- Generic name
- DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE
- Manufacturer
- Reckitt Benckiser LLC
- Product type
- HUMAN OTC DRUG
- Route
- N/A
- Dosage form
- N/A
- NDC
- 72854-083
- Application
- M012
- Label effective
- 20260527
About this product
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE. It is labelled by Reckitt Benckiser LLC and marketed as a human otc drug product. Identifiers on file: NDC 72854-083, application M012, label effective 20260527. It is one of 2 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE are most often described in connection with: temporarily relieves, mucinex children, mighty chews, cough due, minor throat, bronchial irritation, cold controls, get sleep. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses Mucinex Children's Mighty Chews Cough Daytime: temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold Mucinex Children's Mighty Chews Cough Nighttime: ■ 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
Dosage & Administration
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 ■ do not swallow whole 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
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 ■ excitability may occur, especially in chidren ■ 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.
More products with the same ingredient
DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEHow products containing DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE compare
FDA lists 2 drug label records with DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Reckitt Benckiser LLC | 2 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
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Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-1517-2016 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60 | Reckitt Benckiser LLC | Class III | Terminated | 20160928 |
| D-1363-2015 | Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1 | Reckitt Benckiser LLC | Class I | Terminated | 20150902 |
| D-1365-2015 | Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8 | Reckitt Benckiser LLC | Class I | Terminated | 20150902 |
| D-1367-2015 | Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4 | Reckitt Benckiser LLC | Class I | Terminated | 20150902 |
| D-1368-2015 | Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9 | Reckitt Benckiser LLC | Class I | Terminated | 20150902 |
Frequently asked questions
What is Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack used for?
Uses Mucinex Children's Mighty Chews Cough Daytime: temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold Mucinex Children's Mighty Chews Cough Nighttime: ■ 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 …
Who makes Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack?
Reckitt Benckiser LLC is the labeler of record for Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack. 2 FDA label records share the active ingredient DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
Is Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE?
Yes. 2 FDA drug label records list DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.