Tusnel Tablets
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.
Drug Class
Cough and Cold Preparation
Pharmacologic Class
Expectorant; Alpha-adrenergic Agonist; Antitussive
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a combination of three ingredients used to relieve cold and flu symptoms. Guaifenesin helps thin and loosen mucus in your lungs, making it easier to cough up. Pseudoephedrine helps clear stuffy nose and sinuses by reducing swelling. Dextromethorphan helps calm your cough.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe 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. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
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 take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe 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. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
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 take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Drink plenty of fluids (water, clear broths) to help thin mucus and stay hydrated.
- Get adequate rest to support recovery.
- Avoid alcohol while taking this medication as it can increase drowsiness and other side effects.
- Avoid driving or operating heavy machinery until you know how this medication affects you, especially due to potential drowsiness or dizziness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Dosage varies by specific product strength. Typically, 200-400 mg Guaifenesin, 30-60 mg Pseudoephedrine, and 10-20 mg Dextromethorphan every 4-6 hours as needed. Do not exceed maximum daily doses.
Condition-Specific Dosing:
maximumDailyDose:
Guaifenesin: 2400 mg; Pseudoephedrine: 240 mg; Dextromethorphan: 120 mg
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Generally not recommended for children under 6 years of age. For children 6-12 years, dosage should be based on specific product instructions and weight, typically half the adult dose. Consult a healthcare professional.
Adolescent:
Typically adult dosing for adolescents 12 years and older, following product-specific instructions.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required, but use with caution.
Moderate:
Use with caution. Consider reduced frequency or dose, especially for pseudoephedrine and dextromethorphan due to renal excretion.
Severe:
Contraindicated or significant dose reduction required. Pseudoephedrine and dextromethorphan are renally excreted; accumulation can occur. Consult a healthcare professional.
Dialysis:
Not well-studied for combination. Pseudoephedrine is dialyzable. Avoid or use with extreme caution.
Hepatic Impairment:
Mild:
No specific adjustment typically required.
Moderate:
Use with caution. Dextromethorphan is metabolized by CYP2D6; impaired hepatic function may increase exposure. Consider reduced dose or frequency.
Severe:
Use with caution and significant dose reduction. Dextromethorphan metabolism may be significantly impaired, increasing risk of adverse effects. Consult a healthcare professional.
Pharmacology
Mechanism of Action
Guaifenesin is an expectorant that works by increasing the volume and decreasing the viscosity of secretions in the respiratory tract, making coughs more productive. Pseudoephedrine is a sympathomimetic amine that acts as a direct and indirect agonist on alpha-adrenergic receptors, causing vasoconstriction in the nasal mucosa, leading to decongestion. Dextromethorphan is an antitussive that acts centrally on the cough center in the medulla to elevate the cough threshold, suppressing non-productive cough.
Pharmacokinetics
Absorption:
Bioavailability:
Guaifenesin: Not well quantified, rapidly absorbed; Pseudoephedrine: High, well-absorbed; Dextromethorphan: High, well-absorbed
Tmax:
Guaifenesin: ~1 hour; Pseudoephedrine: 0.5-2 hours; Dextromethorphan: ~2 hours
FoodEffect:
Minimal or no significant effect on absorption for all components.
Distribution:
Vd:
Guaifenesin: Not well quantified; Pseudoephedrine: ~2.5 L/kg; Dextromethorphan: Large, ~5-6 L/kg
ProteinBinding:
Guaifenesin: Not significant; Pseudoephedrine: Minimal (<10%); Dextromethorphan: Not significant
CnssPenetration:
Guaifenesin: Limited; Pseudoephedrine: Yes; Dextromethorphan: Yes
Elimination:
HalfLife:
Guaifenesin: ~1 hour; Pseudoephedrine: 9-16 hours (pH dependent); Dextromethorphan: 2-4 hours (parent drug), 10-20 hours (dextrorphan)
Clearance:
Not well quantified for all components in combination.
ExcretionRoute:
Guaifenesin: Renal (metabolites); Pseudoephedrine: Renal (primarily unchanged); Dextromethorphan: Renal (metabolites)
Unchanged:
Guaifenesin: <1%; Pseudoephedrine: 50-90%; Dextromethorphan: <1%
Pharmacodynamics
OnsetOfAction:
Guaifenesin: 30 minutes; Pseudoephedrine: 15-30 minutes; Dextromethorphan: 15-30 minutes
PeakEffect:
Guaifenesin: 1-2 hours; Pseudoephedrine: 1-2 hours; Dextromethorphan: 1-2 hours
DurationOfAction:
Guaifenesin: 4-6 hours; Pseudoephedrine: 4-6 hours; Dextromethorphan: 4-8 hours
Safety & Warnings
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
+ 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. 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 that bother you or do not go away, contact your doctor:
Dizziness
Trouble sleeping
Feeling nervous and excitable
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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.
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
+ 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. 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 that bother you or do not go away, contact your doctor:
Dizziness
Trouble sleeping
Feeling nervous and excitable
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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.
Seek Immediate Medical Attention If You Experience:
- If cough or congestion worsens or lasts more than 7 days (5 days for children)
- If symptoms are accompanied by fever, rash, or persistent headache
- If you experience nervousness, dizziness, or sleeplessness
- If you have a persistent or chronic cough (e.g., due to smoking, asthma, emphysema) or a cough with excessive phlegm, consult a doctor before use.
- Signs of allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
- Signs of serotonin syndrome (agitation, confusion, rapid heart rate, sweating, muscle stiffness, twitching, severe nausea/vomiting/diarrhea)
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. Be sure to describe the allergic reaction and its symptoms.
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 may interact with this drug.
If you have a cough that produces a lot of mucus, a chronic cough caused by smoking or exposure to smoke, or lung conditions such as asthma or emphysema.
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 may have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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. Be sure to describe the allergic reaction and its symptoms.
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 may interact with this drug.
If you have a cough that produces a lot of mucus, a chronic cough caused by smoking or exposure to smoke, or lung conditions such as asthma or emphysema.
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 may have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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. Adhering to the recommended treatment duration is also crucial; do not take this drug for longer than the period specified by your doctor.
When considering administration to children, note that different brands of this medication may be approved for use in various age groups. Therefore, it is crucial to consult with your doctor before giving this drug to a child to ensure the appropriate brand and dosage are used.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss your situation with your doctor. This conversation will help weigh the benefits and risks of taking this medication to both you and your baby, allowing for an informed decision about your treatment.
When considering administration to children, note that different brands of this medication may be approved for use in various age groups. Therefore, it is crucial to consult with your doctor before giving this drug to a child to ensure the appropriate brand and dosage are used.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss your situation with your doctor. This conversation will help weigh the benefits and risks of taking this medication to both you and your baby, allowing for an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Severe dizziness, drowsiness, or confusion
- Nausea, vomiting, stomach pain
- Rapid or irregular heartbeat, high blood pressure
- Hallucinations, agitation, seizures
- Difficulty breathing, shallow breathing
- Urinary retention
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Be prepared to provide information about the medication taken, dose, and time.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOIs due to risk of hypertensive crisis and serotonin syndrome)
Major Interactions
- Other sympathomimetics (e.g., other decongestants, appetite suppressants, amphetamines) - increased cardiovascular effects
- Tricyclic Antidepressants (TCAs) - increased pressor response to pseudoephedrine
- Beta-blockers (non-selective) - may increase pressor effects of pseudoephedrine
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, tramadol, St. John's Wort) - increased risk of serotonin syndrome with dextromethorphan
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased dextromethorphan exposure and risk of toxicity
Moderate Interactions
- Antihypertensives (e.g., guanethidine, methyldopa, reserpine) - pseudoephedrine may reduce their hypotensive effects
- Digitalis glycosides - increased risk of ectopic pacemaker activity with pseudoephedrine
- Alcohol and other CNS depressants - additive CNS depression with dextromethorphan
Minor Interactions
- Not typically listed for OTC combinations, but general caution with other sedating medications.
Monitoring
Symptom Monitoring
- Effectiveness of cough suppression and decongestion
- Presence of productive cough (for guaifenesin effect)
- Adverse effects: insomnia, nervousness, dizziness, headache, nausea, vomiting, increased blood pressure, tachycardia, urinary retention
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Generally classified as Pregnancy Category C. Use during pregnancy should be avoided unless clearly necessary and the potential benefits outweigh the risks. Pseudoephedrine use in the first trimester has been associated with a small, debated risk of gastroschisis. Dextromethorphan and guaifenesin are generally considered low risk, but combination products should be used cautiously.
Trimester-Specific Risks:
First Trimester:
Pseudoephedrine: Possible, though debated, association with gastroschisis. Dextromethorphan/Guaifenesin: Generally considered low risk, but avoid unnecessary medication.
Second Trimester:
Pseudoephedrine: Generally considered safer than first trimester, but still use with caution. Dextromethorphan/Guaifenesin: Low risk.
Third Trimester:
Pseudoephedrine: May cause maternal hypertension or fetal tachycardia; avoid close to term. Dextromethorphan/Guaifenesin: Low risk.
Lactation
Lactation Risk Category L3 (Moderate Concern) primarily due to pseudoephedrine. Pseudoephedrine is excreted into breast milk and can reduce milk supply, especially in mothers with established lactation. Dextromethorphan and guaifenesin are excreted in small amounts and are generally considered compatible with breastfeeding, but caution is advised with combination products.
Infant Risk:
Pseudoephedrine: Irritability, sleep disturbances in infant; potential reduction in milk supply. Dextromethorphan/Guaifenesin: Low risk of adverse effects in infant.
Pediatric Use
Not recommended for children under 6 years of age due to potential for serious side effects and lack of proven efficacy. For children 6-12 years, use only under the guidance of a healthcare professional and follow age/weight-specific dosing instructions on the product label. Overdosing in children can be fatal.
Geriatric Use
Use with caution in elderly patients due to increased sensitivity to the adverse effects of pseudoephedrine (e.g., cardiovascular effects, CNS stimulation, urinary retention) and dextromethorphan (e.g., CNS effects). Start with the lowest effective dose and monitor closely for side effects, especially in those with pre-existing cardiovascular conditions, hypertension, or prostate enlargement.
Clinical Information
Clinical Pearls
- This is an OTC combination product; patients should be advised to read the label carefully for specific strengths and dosing instructions.
- Counsel patients on the importance of not exceeding recommended doses and avoiding other medications containing similar ingredients to prevent accidental overdose.
- Warn patients about potential CNS side effects (drowsiness, dizziness) and cardiovascular side effects (increased heart rate, blood pressure) due to pseudoephedrine.
- Emphasize the contraindication with MAOIs and the risk of serotonin syndrome with other serotonergic drugs due to dextromethorphan.
- Advise patients with chronic cough (e.g., asthma, COPD) or high blood pressure, heart disease, diabetes, or thyroid disease to consult a doctor before using this product.
Alternative Therapies
- Single-ingredient expectorants (e.g., guaifenesin)
- Single-ingredient decongestants (e.g., pseudoephedrine, phenylephrine)
- Single-ingredient antitussives (e.g., dextromethorphan, benzonatate)
- Non-pharmacological treatments: saline nasal sprays, humidifiers, warm liquids, honey (for cough), rest, hydration.
Cost & Coverage
Average Cost:
$5 - $25 per bottle/box (e.g., 20-100 tablets/capsules)
Generic Available:
Yes
Insurance Coverage:
Over-the-counter (OTC), generally not covered by insurance unless prescribed.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.