Mucinex 600 mg/1
Guaifenesin · TABLET, EXTENDED RELEASE · American Health Packaging
Mucinex is a tablet, extended release containing guaifenesin at 600 mg/1, taken oral. Manufactured by American Health Packaging.
Key Facts
- Brand Name
- Mucinex
- Generic Name
- Guaifenesin
- NDC Code (Product)
68084-572- Manufacturer
- American Health Packaging
- Strength
- 600 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA021282
- Drug Class
- Expectorant [EPC]
- Marketing Start
- 02/19/2016
Recall History
Reckitt Benckiser LLC
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Reckitt Benckiser LLC
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Reckitt Benckiser LLC
Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Reckitt Benckiser LLC
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Reckitt Benckiser LLC
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Reckitt Benckiser LLC
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Reckitt Benckiser LLC
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Reckitt Benckiser LLC
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Reckitt Benckiser LLC
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage & Administration
Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use
Warnings
Warnings Do not use for children under 12 years of age Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) 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 illness. 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.
Frequently Asked Questions
What is Mucinex used for?
Mucinex contains Guaifenesin. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Mucinex a controlled substance?
Mucinex is not classified as a controlled substance by the DEA.
What is the generic name for Mucinex?
The generic name for Mucinex is Guaifenesin. There are 12 other brand versions of Guaifenesin.
What is the NDC code for Mucinex 600 mg/1?
The NDC (National Drug Code) for Mucinex 600 mg/1 is 68084-572, listed by American Health Packaging.
Other Guaifenesin Brands
See all →- Guaifenesin and Dextromethorphan Hydrobromide10 mg/5mL72162-2277
- basic care mucus er600 mg/172288-298
- basic care mucus er max1200 mg/172288-613
- Pharbinex-DM20 mg/173057-381
- Mucus Relief DM Extended Release Caplets30 mg/10536-1161
- MUCUS RELIEF - DM MAXIMUM STRENGTH60 mg/173581-405
- BACZOL EXPECTORANT200 mg/5mL76864-209
- Guaifenesin and Pseudoephedrine HCl600 mg/179481-1002
- Meijer Adult Mucus Plus chest congestion200 mg/10mL79481-7430
- Tussin Mucus and Chest Congestion Sugar Free200 mg/10mL82568-0012
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)