Mucinex Childrens Cough
Mucinex Childrens Cough is an FDA drug label for the active ingredient DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN manufactured by Reckitt Benckiser LLC administered by ORAL. 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 20260518.
- Generic name
- DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN
- Manufacturer
- Reckitt Benckiser LLC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 63824-946
- Application
- M012
- Label effective
- 20260518
About this product
Mucinex Childrens Cough is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 63824-946, application M012, label effective 20260518. It is one of 10 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN. 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 HYDROBROMIDE AND GUAIFENESIN are most often described in connection with: helps loosen, phlegm mucus, thin bronchial, secretions rid, passageways bothersome, make coughs, productive temporarily, relieves cough. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep
Dosage & Administration
Directions do not give more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Age Dose children 6 years to under 12 years of age 5 mL – 10 mL every 4 hours children 4 years to under 6 years of age 2.5 mL – 5 mL every 4 hours children under 4 years of age do not use
Warnings
Warnings Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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View labelHow products containing DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN compare
FDA lists 10 drug label records with DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN 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 | 5 |
| — | — | AMERISOURCE BERGEN | 2 |
| — | — | CVS PHARMACY | 1 |
| — | — | CVS PHARMACY, INC | 1 |
| — | — | RARITAN PHARMACEUTICALS INC | 1 |
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 Cough used for?
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep
Who makes Mucinex Childrens Cough?
Reckitt Benckiser LLC is the labeler of record for Mucinex Childrens Cough. 10 FDA label records share the active ingredient DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Mucinex Childrens Cough come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Mucinex Childrens Cough 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 HYDROBROMIDE AND GUAIFENESIN?
Yes. 10 FDA drug label records list DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN 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 Cough 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.