Mucinex Fast-Max Cold/flu Liq

Manufacturer RB HEALTH (US) Active Ingredient Acetaminophen, Dextromethorphan, Guaifenesin, and Phenylephrine Liquid(a SEET a MIN oh fen, DEX troe meth OR fan, gwye FEN e sin, & FEN il EF rin) Pronunciation MYOO-sin-ex FAST-MAX KOHLD/FLOO LIK-wid (a SEET a MIN oh fen, DEX troe meth OR fan, gwye FEN e sin, & FEN il EF rin)
It is used to treat nose stuffiness.It is used to thin mucus so it can be taken from the body by coughing.It is used to relieve coughing.It is used to ease pain and fever.
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Drug Class
Cold and Flu Symptom Relief
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Pharmacologic Class
Analgesic (Para-aminophenol derivative), Antitussive (Morphinan derivative), Expectorant (Guaiacol derivative), Decongestant (Alpha-adrenergic agonist)
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mucinex Fast-Max Cold/Flu Liquid is an over-the-counter medicine used to relieve common cold and flu symptoms. It contains four active ingredients: Acetaminophen helps reduce fever and relieve aches and pains. Dextromethorphan helps suppress cough. Guaifenesin helps thin and loosen mucus, making it easier to cough up. Phenylephrine helps clear stuffy nose and sinus congestion.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience an upset stomach, taking it with food may help. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

To ensure accurate dosing, measure liquid medications carefully using the device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring tool.

Storing and Disposing of Your Medication

Store your medication at room temperature, avoiding refrigeration or freezing. Keep it in a dry place, away from bathrooms. Ensure all medications are stored safely, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than advised.
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Lifestyle & Tips

  • Drink plenty of fluids (water, clear broths) to help thin mucus and stay hydrated.
  • Get adequate rest to support your body's recovery.
  • Avoid alcohol while taking this medication, as it can increase the risk of liver damage with acetaminophen.
  • Do not take with other medications containing acetaminophen, dextromethorphan, guaifenesin, or phenylephrine to avoid overdose.
  • Avoid driving or operating machinery if you experience dizziness or drowsiness.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mL (containing Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg) every 4 hours
Dose Range: 20 - 120 mg

Condition-Specific Dosing:

maxDailyDose: Do not exceed 6 doses (120 mL) in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended for children under 4 years)
Child: Children 6 to under 12 years: 10 mL every 4 hours (max 6 doses/24 hours); Children under 6 years: Consult a doctor
Adolescent: 12 years and older: 20 mL every 4 hours (max 6 doses/24 hours)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Use with caution; consider dose reduction or extended dosing interval, especially for acetaminophen and phenylephrine. Consult a physician.
Severe: Contraindicated or significant dose adjustment required. Consult a physician. Acetaminophen accumulation risk.
Dialysis: Acetaminophen is dialyzable. Consult a physician for specific guidance.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Contraindicated or significant dose adjustment required due to acetaminophen. Consult a physician.
Severe: Contraindicated due to acetaminophen hepatotoxicity risk.

Pharmacology

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Mechanism of Action

Acetaminophen: Produces analgesia by inhibiting prostaglandin synthesis in the central nervous system and peripherally blocking pain impulse generation. Produces antipyresis by inhibiting the hypothalamic heat-regulating center. Dextromethorphan: Acts centrally on the cough center in the medulla to elevate the cough threshold. Guaifenesin: Acts as an expectorant by increasing the volume and decreasing the viscosity of secretions in the trachea and bronchi, thereby facilitating removal of the secretions by ciliary action and cough reflex. Phenylephrine: A direct-acting sympathomimetic amine that acts on alpha-adrenergic receptors in the arterioles of the nasal mucosa to produce vasoconstriction, leading to reduced swelling and congestion.
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Pharmacokinetics

Absorption:

Bioavailability: Acetaminophen: 60-90%; Dextromethorphan: Variable (extensive first-pass); Guaifenesin: Rapid; Phenylephrine: Low oral (extensive first-pass)
Tmax: Acetaminophen: 0.5-2 hours; Dextromethorphan: 2-2.5 hours; Guaifenesin: ~1 hour; Phenylephrine: 0.5-2 hours
FoodEffect: May slightly delay absorption of acetaminophen but not significantly affect extent.

Distribution:

Vd: Acetaminophen: 0.9 L/kg; Dextromethorphan: High; Guaifenesin: Not widely distributed; Phenylephrine: Not widely distributed
ProteinBinding: Acetaminophen: 10-25%; Dextromethorphan: Not significant; Guaifenesin: Not significant; Phenylephrine: Not significant
CnssPenetration: Acetaminophen: Yes; Dextromethorphan: Yes; Guaifenesin: Limited; Phenylephrine: Limited

Elimination:

HalfLife: Acetaminophen: 1-4 hours; Dextromethorphan: 1.5-4 hours (extensive metabolizers); Guaifenesin: ~1 hour; Phenylephrine: 2-3 hours
Clearance: Acetaminophen: Renal; Dextromethorphan: Renal; Guaifenesin: Renal; Phenylephrine: Renal
ExcretionRoute: Renal
Unchanged: Acetaminophen: <5%; Dextromethorphan: <1%; Guaifenesin: <1%; Phenylephrine: <16%
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Pharmacodynamics

OnsetOfAction: Acetaminophen: 30-60 minutes; Dextromethorphan: 15-30 minutes; Guaifenesin: 30 minutes; Phenylephrine: 15-30 minutes
PeakEffect: Acetaminophen: 1-2 hours; Dextromethorphan: 1-2 hours; Guaifenesin: 1-2 hours; Phenylephrine: 1-2 hours
DurationOfAction: Acetaminophen: 4-6 hours; Dextromethorphan: 5-6 hours; Guaifenesin: 4-6 hours; Phenylephrine: 4 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Chest pain or pressure
Rapid heartbeat
Shakiness
Difficulty urinating or changes in urine output
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Dizziness
Feeling nervous and excitable
* Difficulty sleeping

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms worsen or last more than 7 days (5 days for children)
  • Fever worsens or lasts more than 3 days
  • New symptoms appear
  • Redness or swelling is present
  • Cough comes back or occurs with rash or persistent headache
  • Nervousness, dizziness, or sleeplessness occurs
  • Signs of liver problems (yellowing skin/eyes, dark urine, severe stomach pain)
  • Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have liver disease, as this may affect how your body processes the medication.
If you have a cough that produces a significant amount of mucus, a chronic cough caused by smoking or exposure to smoke, or lung conditions like asthma or emphysema.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
* If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to assess potential interactions and ensure it is safe for you to take this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Additionally, do not take this medication for a longer duration than recommended by your doctor.

This medication contains acetaminophen, which has been associated with liver problems, including the need for a liver transplant or even death, particularly when taken in excessive amounts. The majority of these cases involved individuals taking more than 4,000 milligrams (mg) of acetaminophen per day, often in combination with multiple products containing acetaminophen.

To minimize the risk of liver problems, it is crucial to avoid taking other products that contain acetaminophen. Carefully examine the labels of all medications and supplements to ensure you are not exceeding the recommended daily intake of acetaminophen. Follow the dosage instructions precisely, and do not exceed the maximum daily dose of acetaminophen as directed by your doctor or pharmacist. The recommended daily limit is 4,000 mg for some individuals, but those with liver problems or children may require a lower dose. If you are unsure about the safe amount of acetaminophen for your specific situation, consult your doctor or pharmacist. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you are not experiencing any symptoms.

Before consuming alcohol, discuss the potential risks with your doctor. It is also important to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results. If you are following a low-sodium or sodium-free diet, consult your doctor, as some formulations of this medication may contain sodium.

When considering administering this medication to a child, consult your doctor first, as different brands may be suitable for different age groups. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Stomach pain
  • Loss of appetite
  • Sweating
  • Extreme tiredness
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Confusion
  • Hallucinations
  • Seizures
  • High blood pressure
  • Rapid heartbeat

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Overdose of acetaminophen can cause severe, potentially fatal liver damage. Overdose of phenylephrine can cause dangerously high blood pressure. Overdose of dextromethorphan can cause significant CNS depression or excitation.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of stopping MAOIs (risk of hypertensive crisis with phenylephrine, serotonin syndrome with dextromethorphan)
  • Other acetaminophen-containing products (risk of overdose)
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Major Interactions

  • Alcohol (increased risk of liver damage with acetaminophen)
  • Warfarin (increased INR with acetaminophen, especially with chronic high doses)
  • Other sympathomimetics (e.g., decongestants, appetite suppressants, amphetamines - increased risk of cardiovascular effects with phenylephrine)
  • Tricyclic antidepressants (TCAs) (potentiate pressor effects of phenylephrine)
  • Beta-blockers (may increase pressor effects of phenylephrine)
  • Serotonergic drugs (e.g., SSRIs, SNRIs, triptans - increased risk of serotonin syndrome with dextromethorphan)
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine - increased dextromethorphan exposure)
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Moderate Interactions

  • Anticholinergic drugs (may reduce GI motility, potentially affecting absorption)
  • Certain antiepileptic drugs (e.g., carbamazepine, phenytoin - increased risk of acetaminophen hepatotoxicity)
  • Cholestyramine (reduces acetaminophen absorption)
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Minor Interactions

  • None commonly cited for this combination

Monitoring

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Baseline Monitoring

Medical history (hypertension, heart disease, diabetes, thyroid disease, liver/kidney disease, glaucoma, prostate enlargement)

Rationale: To identify contraindications or conditions requiring caution due to phenylephrine and acetaminophen.

Timing: Prior to initiation

Current medication list

Rationale: To identify potential drug interactions, especially with MAOIs, other acetaminophen products, or sympathomimetics.

Timing: Prior to initiation

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Routine Monitoring

Symptom improvement (cough, congestion, pain, fever)

Frequency: Daily

Target: Resolution or significant reduction of symptoms

Action Threshold: If symptoms worsen or persist for more than 7 days (5 days for children), or if fever worsens or lasts more than 3 days, discontinue and consult a doctor.

Adverse effects (e.g., dizziness, nervousness, insomnia, elevated blood pressure, liver toxicity symptoms)

Frequency: Daily

Target: Absence of significant adverse effects

Action Threshold: If severe side effects occur, discontinue and seek medical attention. Signs of liver damage (yellowing skin/eyes, dark urine, abdominal pain) require immediate medical attention.

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Symptom Monitoring

  • Persistent or worsening cough
  • Cough with excessive mucus or blood
  • High fever (over 103°F or 39.4°C)
  • Fever lasting more than 3 days
  • Rash
  • Persistent headache
  • Nervousness, dizziness, or sleeplessness
  • Significant increase in blood pressure or heart rate
  • Signs of liver damage (yellowing of skin/eyes, dark urine, severe abdominal pain)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Acetaminophen is generally considered safe in pregnancy at recommended doses, but dextromethorphan, guaifenesin, and phenylephrine have limited human data or animal studies showing adverse effects at high doses. Consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Avoid if possible, especially phenylephrine due to potential vascular effects.
Second Trimester: Use with caution, generally considered safer than first trimester for some components.
Third Trimester: Use with caution, phenylephrine may cause uterine vasoconstriction. Avoid close to term.
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Lactation

L3 (Moderately Safe). Acetaminophen is generally considered safe. Dextromethorphan, guaifenesin, and phenylephrine are excreted into breast milk in small amounts. Monitor infant for drowsiness, irritability, or feeding difficulties. Consult a healthcare provider before use.

Infant Risk: Low to moderate risk. Potential for infant drowsiness or irritability, especially with higher doses or prolonged use. Phenylephrine may reduce milk supply.
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Pediatric Use

Not for use in children under 6 years of age without consulting a doctor. For children 6-12 years, use pediatric-specific formulations and dosing. Always use the dosing device provided with the product. Accidental overdose is a significant risk in this population.

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Geriatric Use

Use with caution in elderly patients, especially those with pre-existing conditions such as hypertension, heart disease, diabetes, or prostate enlargement, due to the phenylephrine component. Start with the lowest effective dose and monitor for adverse effects. Increased sensitivity to CNS and cardiovascular effects may occur.

Clinical Information

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Clinical Pearls

  • Always check the active ingredients of other medications being taken to avoid accidental overdose, especially with acetaminophen.
  • Advise patients with high blood pressure, heart disease, diabetes, or thyroid disease to consult a doctor before using due to the phenylephrine content.
  • Counsel patients on the importance of not exceeding the recommended dose and duration of use.
  • This product is for symptomatic relief and does not treat the underlying cause of the cold or flu.
  • Encourage non-pharmacological measures like rest and hydration alongside medication.
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Alternative Therapies

  • Single-ingredient acetaminophen for pain/fever
  • Single-ingredient dextromethorphan for cough
  • Single-ingredient guaifenesin for mucus
  • Single-ingredient phenylephrine or pseudoephedrine for congestion
  • Nasal saline sprays for congestion
  • Honey for cough (for children over 1 year)
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Cost & Coverage

Average Cost: $10 - $20 per 6 fl oz (177 mL) bottle
Generic Available: Yes
Insurance Coverage: OTC (Out-of-pocket, may be HSA/FSA eligible)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.