Mucinex Childrens Mini Melts Cold and Flu
Mucinex Childrens Mini Melts Cold and Flu is an FDA drug label for the active ingredient ACETAMINOPHEN 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 20260519.
- Generic name
- ACETAMINOPHEN AND GUAIFENESIN
- Manufacturer
- Reckitt Benckiser LLC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 72854-090
- Application
- M012
- Label effective
- 20260519
About this product
Mucinex Childrens Mini Melts Cold and Flu is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN AND GUAIFENESIN. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 72854-090, application M012, label effective 20260519. 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 ACETAMINOPHEN AND GUAIFENESIN are most often described in connection with: temporarily relieves, minor aches, pains due, common cold, flu headache, sore throat, reduces fever, helps loosen. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses Temporarily relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ temporarily reduces fever ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage & Administration
Directions empty entire contents of packet onto tongue and swallow for best taste, do not chew granules Age Dose adults and Children 12 years of age and over 2 to 4 packets every 4 hours, not to exceed 6 doses (24 packets) in 24 hours children 6 years to under 12 years of age 2 packets every 4 hours, not to exceed 5 doses (10 packets) in 24 hours children under 6 years of age do not use
Warnings
Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 6 doses (24 packets) in 24 hours, which is the maximum daily amount ■ child takes more than 5 doses (10 packets) in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks every day while using this product Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blister ■ rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting; consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have Ask a doctor before use if the user has ■ liver disease ■ persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough accompanied by too much phlegm (mucus) Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with 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.
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 Mini Melts Cold and Flu used for?
Uses Temporarily relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ temporarily reduces fever ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Who makes Mucinex Childrens Mini Melts Cold and Flu?
Reckitt Benckiser LLC is the labeler of record for Mucinex Childrens Mini Melts Cold and Flu.
What form does Mucinex Childrens Mini Melts Cold and Flu 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 Mini Melts Cold and Flu 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.
Has Mucinex Childrens Mini Melts Cold and Flu 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.