Tussin DM Max 20mg-400mg/20ml Liq

Manufacturer RELIABLE 1 LABS Active Ingredient Guaifenesin and Dextromethorphan Liquid(gwye FEN e sin & deks troe meth OR fan) Pronunciation Guaifenesin (gwye FEN e sin) & Dextromethorphan (deks troe meth OR fan)
It is used to thin mucus so it can be taken from the body by coughing.It is used to relieve coughing.
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Drug Class
Expectorant, Antitussive
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Pharmacologic Class
Expectorant (Guaifenesin); NMDA receptor antagonist, Sigma-1 receptor agonist (Dextromethorphan)
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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?

This medicine helps to relieve cough and chest congestion. Guaifenesin helps to thin and loosen mucus in your lungs, making it easier to cough up. Dextromethorphan helps to reduce the urge to cough.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
When taking a liquid dose, measure it carefully using the device provided with your medication. If no device is included, ask your pharmacist for a suitable measuring tool.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

Store it at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a secure location, out of the 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 drug take-back programs in your area.

What to Do If You Miss a Dose

If you take your medication on a regular schedule:

Take the missed dose as soon as you remember.
If it's almost time for your next dose, skip the missed dose and continue with your regular schedule.
Do not take two doses at once or take extra doses.
If you take your medication as needed, do not take it more frequently than advised by your doctor.
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Lifestyle & Tips

  • Drink plenty of fluids (water, juice) to help loosen mucus.
  • Avoid irritants like smoke, dust, and pollutants.
  • Use a humidifier to moisten the air.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 ml (Dextromethorphan HBr 20 mg, Guaifenesin 400 mg) every 4 hours as needed
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: 4 to under 6 years: Consult a doctor. 6 to under 12 years: 10 ml (Dextromethorphan HBr 10 mg, Guaifenesin 200 mg) every 4 hours as needed. Max 6 doses/24 hours. Not recommended for children under 4 years.
Adolescent: 12 years and older: 20 ml (Dextromethorphan HBr 20 mg, Guaifenesin 400 mg) every 4 hours as needed. Max 6 doses/24 hours.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended for OTC use, use with caution.
Moderate: No specific adjustment recommended for OTC use, use with caution.
Severe: No specific adjustment recommended for OTC use, use with caution. Consider reduced frequency or dose due to potential accumulation of guaifenesin metabolites.
Dialysis: Not specifically studied; use with caution. Guaifenesin metabolites are renally excreted.

Hepatic Impairment:

Mild: No specific adjustment recommended for OTC use, use with caution.
Moderate: No specific adjustment recommended for OTC use, use with caution. Dextromethorphan is metabolized by CYP2D6; consider reduced dose or increased interval in severe impairment.
Severe: No specific adjustment recommended for OTC use, use with caution. Dextromethorphan metabolism may be significantly impaired; consider reduced dose or increased interval.

Pharmacology

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Mechanism of Action

Guaifenesin acts as an expectorant by increasing the volume and decreasing the viscosity of respiratory tract secretions, thereby facilitating their removal by ciliary action and coughing. Dextromethorphan acts centrally on the cough center in the medulla oblongata to elevate the cough threshold, thereby suppressing the cough reflex. It is an NMDA receptor antagonist and sigma-1 receptor agonist.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified for combination; both are well absorbed orally.
Tmax: Guaifenesin: ~1 hour; Dextromethorphan: ~2-2.5 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect bioavailability.

Distribution:

Vd: Guaifenesin: Not well-defined; Dextromethorphan: ~5-6 L/kg
ProteinBinding: Guaifenesin: ~10-20%; Dextromethorphan: ~60-70%
CnssPenetration: Yes (Dextromethorphan); Limited (Guaifenesin)

Elimination:

HalfLife: Guaifenesin: ~1 hour; Dextromethorphan: ~3-4 hours (parent drug), Dextrorphan: ~10-20 hours
Clearance: Not precisely quantified for combination.
ExcretionRoute: Guaifenesin: Renal (as inactive metabolites); Dextromethorphan: Renal (as parent drug and metabolites)
Unchanged: Guaifenesin: <1%; Dextromethorphan: <1% (parent drug)
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Pharmacodynamics

OnsetOfAction: Guaifenesin: ~30 minutes; Dextromethorphan: ~15-30 minutes
PeakEffect: Guaifenesin: ~1 hour; Dextromethorphan: ~2-3 hours
DurationOfAction: Guaifenesin: ~4-6 hours; Dextromethorphan: ~5-6 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs of a severe allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat

Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with your doctor.

Reporting Side Effects
For medical advice about side effects, contact your doctor. 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:

  • Cough that lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
  • Severe dizziness, drowsiness, or confusion.
  • Nervousness, restlessness, or difficulty sleeping.
  • Signs of serotonin syndrome (e.g., agitation, hallucinations, rapid heartbeat, fever, overactive reflexes, nausea, vomiting, diarrhea) if taking other medications.
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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:

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.
Respiratory issues, including:
+ A cough that produces a significant amount of mucus
+ A chronic cough caused by smoking or exposure to smoke
+ Lung conditions like asthma or emphysema
Use of certain medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications with this drug may lead to severely high blood pressure.
Concurrent use of:
+ Linezolid
+ Methylene blue
Note: This is not an exhaustive list of interacting medications.

To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:

All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
* Existing health problems
Verify that it is safe to take this medication with your other medications and health conditions before starting treatment. Do not initiate, discontinue, or adjust the dosage of any medication without consulting your doctor.
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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.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount can increase your chances of experiencing serious adverse effects.

Adhere to the treatment duration specified by your doctor and avoid taking this medication for longer than prescribed.

If you are following a low-sodium or sodium-free diet, consult your doctor before taking this medication, as some formulations may contain sodium.

Individuals with phenylketonuria (PKU) should discuss their condition with their doctor, as certain products may contain phenylalanine.

Note that some forms of this medication may not be suitable for children of all ages. If you have any concerns or questions, consult your doctor for guidance.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Dizziness
  • Drowsiness
  • Confusion
  • Agitation
  • Hallucinations
  • Rapid heart rate
  • Uncontrolled muscle movements (ataxia)
  • Respiratory depression (severe cases)

What to Do:

Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Bring the product packaging with you.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping MAOI therapy (risk of serotonin syndrome with Dextromethorphan)
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid, St. John's Wort) - increased risk of serotonin syndrome with Dextromethorphan
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, amiodarone, bupropion) - may increase dextromethorphan levels and adverse effects
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Moderate Interactions

  • CNS depressants (e.g., alcohol, sedatives, tranquilizers) - additive CNS depression
  • Other cough/cold products containing dextromethorphan or guaifenesin - risk of overdose
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Minor Interactions

  • Not specifically identified for guaifenesin at typical OTC doses.

Monitoring

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Routine Monitoring

Symptom resolution (cough, mucus)

Frequency: Daily

Target: Improvement or resolution of symptoms

Action Threshold: If cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Adverse effects (e.g., dizziness, nausea, drowsiness)

Frequency: Daily

Target: Absence or mild, tolerable effects

Action Threshold: If severe or persistent, discontinue use and seek medical attention.

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Symptom Monitoring

  • Cough frequency and severity
  • Mucus production and consistency
  • Presence of fever, rash, or persistent headache (signs of underlying condition)
  • Signs of serotonin syndrome (agitation, confusion, rapid heart rate, muscle rigidity, sweating, diarrhea) if taken with serotonergic drugs
  • Signs of CNS depression (drowsiness, dizziness)

Special Patient Groups

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Pregnancy

Generally considered Category C. Use only if the potential benefit justifies the potential risk to the fetus. Consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Limited data, generally avoided unless essential.
Second Trimester: Considered safer than first trimester, but still use with caution.
Third Trimester: Considered safer than first trimester, but still use with caution. Dextromethorphan has been used without clear evidence of harm.
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Lactation

L3 (Moderately Safe). Both guaifenesin and dextromethorphan are excreted into breast milk in small amounts. Monitor infant for drowsiness or irritability. Consult a healthcare provider.

Infant Risk: Low to moderate risk of drowsiness or irritability in the infant. Guaifenesin is generally considered compatible with breastfeeding. Dextromethorphan is also generally considered compatible, but caution is advised, especially with high doses or in infants with poor feeding.
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Pediatric Use

Not recommended for children under 4 years of age. For children 4-12 years, use only under the guidance of a healthcare professional and use age-appropriate dosing. Risk of accidental overdose is higher in young children.

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Geriatric Use

Use with caution in elderly patients, as they may be more sensitive to the sedative effects of dextromethorphan and may have underlying medical conditions or be taking other medications that could interact. Start with the lowest effective dose.

Clinical Information

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Clinical Pearls

  • Advise patients to drink plenty of water to maximize the expectorant effect of guaifenesin.
  • Warn patients about the potential for drowsiness, especially when driving or operating machinery.
  • Emphasize the importance of not exceeding the recommended dose and avoiding other cough/cold products containing the same active ingredients.
  • Counsel patients to avoid alcohol while taking this medication due to additive CNS depressant effects.
  • Strictly contraindicate use with MAOIs due to the risk of serotonin syndrome.
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Alternative Therapies

  • Single-ingredient Guaifenesin (for chest congestion only)
  • Single-ingredient Dextromethorphan (for cough suppression only)
  • Other antitussives (e.g., benzonatate, codeine - prescription only)
  • Other expectorants (e.g., saline nasal spray, steam inhalation)
  • Non-pharmacological measures (e.g., honey for cough, hydration)
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Cost & Coverage

Average Cost: Varies, typically $5-$15 per 118-236 ml bottle
Generic Available: Yes
Insurance Coverage: Generally not covered by prescription insurance as it is an OTC product, but may be eligible for FSA/HSA.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 medication taken, the amount, and the time it occurred.