Reckitt Benckiser LLC
| Product Description: | Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-526-22 |
|---|---|
| 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 |
Reckitt Benckiser LLC
| Product Description: | Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, 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 63824-500-66, UPC 63824-50066-09 |
|---|---|
| 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: | 717,336 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 Cold And Mucinex Fast-max Night Time Cold And Flu Maximum Strength
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Questions & Answers
Question
This medication makes me feel exhausted and dehydrated, so I don’t take it.
Side Effects & Adverse Reactions
Liver warning
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
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.
- with any other drug containing diphenhydramine, even one used on the skin (Mucinex FAST-MAX NIGHT TIME Cold & Flu 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- a breathing problem such as emphysema or chronic bronchitis (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Mucinex FAST-MAX DAY TIME Severe Cold only)
- cough that occurs with too much phlegm (mucus) (Mucinex FAST-MAX DAY TIME Severe Cold only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
When using this product
- do not use more than directed
- excitability may occur, especially in children (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- marked drowsiness may occur (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- avoid alcoholic drinks (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- be careful when driving a motor vehicle or operating machinery (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 7 days
- fever gets worse, or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash, or headache that lasts. These could be a sign of a serious condition. (Mucinex FAST-MAX DAY TIME Severe Cold only)
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning
Do not use
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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.
- with any other drug containing diphenhydramine, even one used on the skin (Mucinex FAST-MAX NIGHT TIME Cold & Flu 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- a breathing problem such as emphysema or chronic bronchitis (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Mucinex FAST-MAX DAY TIME Severe Cold only)
- cough that occurs with too much phlegm (mucus) (Mucinex FAST-MAX DAY TIME Severe Cold only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 7 days
- fever gets worse, or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash, or headache that lasts. These could be a sign of a serious condition. (Mucinex FAST-MAX DAY TIME Severe Cold only)
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 these common cold and flu symptoms:
- nasal congestion
- cough (Mucinex FAST-MAX DAY TIME Severe Cold only)
- minor aches and pains
- headache
- sore throat
- runny nose and sneezing (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Mucinex FAST-MAX DAY TIME Severe Cold only)
- temporarily reduces fever
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 Cold 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 Cold And Mucinex Fast-max Night Time Cold And Flu Maximum Strength (Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, And Phenylephrine Hydrochloride) Kit [Reckitt Benckiser Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Mucinex Fast-max Day Time Severe Cold 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 Cold 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 packets in any 24-hour period adults and children 12 years of age and older: 1 packet every 4 hours dissolve contents of one packet into 8 oz of hot water and stir; sip while hot. Consume within 15 minutes. children under 12 years of age: do not use -
Reckitt Benckiser Llc
Mucinex Fast-max Day Time Severe Cold 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 with product dose as follows or as directed by a doctor adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use -
Reckitt Benckiser Llc
Mucinex Fast-max Day Time Severe Cold And Mucinex Fast-max Night Time Cold And Flu Maximum Strength | Walgreen Co.
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
![Mucinex Fast-max Day Time Severe Cold 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=d27377a5-a58d-4fb9-b042-83a012ba1dbf&name=mucinex-01.jpg)
![Mucinex Fast-max Day Time Severe Cold 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=19228ba2-098d-47d0-9029-804b4627f98d&name=mucinex-01.jpg)
![Mucinex Fast-max Day Time Severe Cold And Mucinex Fast-max Night Time Cold And Flu Maximum Strength (Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, And Phenylephrine Hydrochloride) Kit [Reckitt Benckiser Llc]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
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