Reckitt Benckiser LLC
| Product Description: | 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 |
|---|---|
| Status: | Ongoing |
| City: | Parsippany |
| State: | NJ |
| Country: | US |
| Voluntary/Mandated: | Voluntary: Firm Initiated |
| Initial Firm Notification: | Letter |
| Distribution Pattern: | Nationwide |
| Classification: | Class I |
| Product Quantity: | 561,390 Bottles |
| Reason For Recall: | 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. |
| Recall Initiation Date: | 20150415 |
| Report Date: | 20150902 |
Mucinex Fast-max Day Time Severe Congestion And Cough And Mucinex Fast-max Night Time Cold And Flu Maximum Strength
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Questions & Answers
Side Effects & Adverse Reactions
Liver warning (NIGHT TIME only)
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs that contain acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning (NIGHT TIME only): 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. (NIGHT TIME only)
- with any other drug containing diphenhydramine, even one used on the skin (NIGHT TIME only)
- 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.
- for children under 12 years of age
Ask a doctor before use if you have
- liver disease (NIGHT TIME only)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma (NIGHT TIME only)
- a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME only)
- cough that occurs with too much phlegm (mucus) (DAY TIME only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin (NIGHT TIME only)
- taking sedatives or tranquilizers (NIGHT TIME only)
When using this product do not use more than directed. In addition, for NIGHT TIME only:
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with a fever (DAY TIME only)
- pain, nasal congestion, or cough gets worse, or lasts more than 7 days (NIGHT TIME only)
- fever gets worse, or lasts more than 3 days (NIGHT TIME only)
- redness or swelling is present (NIGHT TIME only)
- new symptoms occur (NIGHT TIME only)
- cough comes back, or occurs with fever, 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.
Overdose warning
Do not use
Taking more than the recommended dose (overdose) may cause liver damage. (NIGHT TIME only)
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (NIGHT TIME only)
- with any other drug containing diphenhydramine, even one used on the skin (NIGHT TIME only)
- 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.
- for children under 12 years of age
- liver disease (NIGHT TIME only)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma (NIGHT TIME only)
- a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME only)
- cough that occurs with too much phlegm (mucus) (DAY TIME only)
- taking the blood thinning drug warfarin (NIGHT TIME only)
- taking sedatives or tranquilizers (NIGHT TIME only)
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with a fever (DAY TIME only)
- pain, nasal congestion, or cough gets worse, or lasts more than 7 days (NIGHT TIME only)
- fever gets worse, or lasts more than 3 days (NIGHT TIME only)
- redness or swelling is present (NIGHT TIME only)
- new symptoms occur (NIGHT TIME only)
- cough comes back, or occurs with fever, rash, or headache that lasts.
These could be signs of a serious condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- temporarily relieves (DAY TIME only):
- 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 you get to sleep
- nasal congestion due to a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
- temporarily relieves these common cold and flu symptoms (NIGHT TIME only):
- nasal congestion
- minor aches and pains
- headache
- sore throat
- runny nose and sneezing
- temporarily reduces fever (NIGHT TIME only)
- controls cough to help you get to sleep
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Mucinex Fast-max Day Time Severe Congestion And Cough And Mucinex Fast-max Night Time Cold And Flu Maximum Strength Manufacturers
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Reckitt Benckiser Llc
![Mucinex Fast-max Day Time Severe Congestion And Cough And Mucinex Fast-max Night Time Cold And Flu Maximum Strength (Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Acetaminophen, And Diphenhydramine Hydrochloride) Kit [Reckitt Benckiser Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Mucinex Fast-max Day Time Severe Congestion And Cough And Mucinex Fast-max Night Time Cold And Flu Maximum Strength | Reckitt Benckiser Llc
do not take more than directed (see Overdose warning) do not take more than 12 caplets in any 24-hour period adults and children 12 years of age and older: take 2 caplets every 4 hours children under 12 years of age: do not use -
Reckitt Benckiser Llc
Mucinex Fast-max Day Time Severe Congestion And Cough And Mucinex Fast-max Night Time Cold And Flu Maximum Strength | Reckitt Benckiser Llc
do not take more than directed (see Overdose warning) do not take 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 mL = milliliter adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use
![Mucinex Fast-max Day Time Severe Congestion And Cough And Mucinex Fast-max Night Time Cold And Flu Maximum Strength (Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, And Phenylephrine Hydrochloride) Kit [Reckitt Benckiser Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=348f581d-eb63-44c3-8f67-c7eb47fdf170&name=ms-mucinex-01.jpg)
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