Giltuss TR 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
Expectorant, Antitussive, Nasal Decongestant
Pharmacologic Class
Guaiacolate, Morphine derivative (non-opioid), Alpha-1 adrenergic agonist
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a combination product used to relieve chest congestion, thin mucus, suppress cough, and clear stuffy nose due to colds or allergies. Guaifenesin helps loosen phlegm, dextromethorphan helps stop coughing, and phenylephrine helps reduce nasal stuffiness.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.
It's also important to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets to avoid accidental ingestion.
When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless your doctor or pharmacist instructs you to do so. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose 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 dosing schedule. Do not take two doses at the same time or take extra doses.
If you take this medication as needed, be sure to follow your doctor's instructions and do not take it more frequently than recommended.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.
It's also important to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets to avoid accidental ingestion.
When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless your doctor or pharmacist instructs you to do so. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose 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 dosing schedule. Do not take two doses at the same time or take extra doses.
If you take this medication as needed, be sure to follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Drink plenty of fluids (water, clear broths) to help loosen mucus.
- Avoid irritants like smoke and allergens.
- Use a humidifier to moisten the air.
- Get adequate rest.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 tablet every 4 hours as needed, not to exceed 6 tablets in 24 hours
Dose Range:
1 - 6 mg
Condition-Specific Dosing:
maximumDailyDose:
Guaifenesin: 2400 mg; Dextromethorphan: 120 mg; Phenylephrine: 60 mg
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age without physician consultation. For ages 12 and older, adult dosing applies.
Adolescent:
For ages 12 and older, adult dosing applies.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for OTC use, but use with caution.
Moderate:
No specific adjustment recommended for OTC use, but use with caution.
Severe:
Use with caution; consult physician. Phenylephrine elimination may be impaired.
Dialysis:
Not well studied; use with caution. Consult physician.
Hepatic Impairment:
Mild:
No specific adjustment recommended for OTC use, but use with caution.
Moderate:
No specific adjustment recommended for OTC use, but use with caution.
Severe:
Use with caution; consult physician. Dextromethorphan and Phenylephrine are metabolized in the liver.
Confidence:
Medium
Pharmacology
Mechanism of Action
Guaifenesin acts as an expectorant by increasing the volume and decreasing the viscosity of secretions in the trachea and bronchi, thereby facilitating the removal of mucus. Dextromethorphan is an antitussive that acts centrally on the cough center in the medulla to elevate the cough threshold. Phenylephrine is a selective alpha-1 adrenergic agonist that causes vasoconstriction in the nasal mucosa, leading to reduced swelling and congestion.
Pharmacokinetics
Absorption:
Bioavailability:
Guaifenesin: Well absorbed; Dextromethorphan: Well absorbed; Phenylephrine: Low oral bioavailability (approx. 38%) due to extensive first-pass metabolism.
Tmax:
Guaifenesin: 1 hour; Dextromethorphan: 2-2.5 hours; Phenylephrine: 0.75-2 hours
FoodEffect:
Not significantly affected by food for Guaifenesin and Dextromethorphan. Food may slightly delay phenylephrine absorption but does not significantly alter extent.
Distribution:
Vd:
Guaifenesin: Not extensively distributed; Dextromethorphan: Large (5-6 L/kg); Phenylephrine: Not extensively distributed
ProteinBinding:
Guaifenesin: Not significant; Dextromethorphan: 60-70%; Phenylephrine: Not significant
CnssPenetration:
Guaifenesin: Limited; Dextromethorphan: Yes (central action); Phenylephrine: Limited
Elimination:
HalfLife:
Guaifenesin: 1 hour; Dextromethorphan: 1.4-3.9 hours (parent), 3.4-5.6 hours (dextrorphan); Phenylephrine: 2-3 hours
Clearance:
Not readily available for combination product, varies by individual component.
ExcretionRoute:
Guaifenesin: Renal (metabolites); Dextromethorphan: Renal (unchanged and metabolites); Phenylephrine: Renal (unchanged and metabolites)
Unchanged:
Guaifenesin: <1%; Dextromethorphan: 10% (parent), 45-80% (metabolites); Phenylephrine: 2.6% (oral)
Pharmacodynamics
OnsetOfAction:
Guaifenesin: 30 minutes; Dextromethorphan: 15-30 minutes; Phenylephrine: 15-60 minutes (oral)
PeakEffect:
Guaifenesin: 1 hour; Dextromethorphan: 2-2.5 hours; Phenylephrine: 1-2 hours
DurationOfAction:
Guaifenesin: 4-6 hours; Dextromethorphan: 5-6 hours; Phenylephrine: 4-6 hours
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away, as they may be related to a serious side effect:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild side effects. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Dizziness
- Feeling nervous and excitable
- Trouble sleeping
Important Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away, as they may be related to a serious side effect:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild side effects. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Dizziness
- Feeling nervous and excitable
- Trouble sleeping
Important Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. 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.
Seek Immediate Medical Attention If You Experience:
- Symptoms worsen or last more than 7 days (or 5 days for children)
- Cough returns or occurs with fever, rash, or persistent headache
- Nervousness, dizziness, or sleeplessness
- Significant increase in blood pressure or heart rate
- Allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
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 you experienced, including any symptoms that occurred.
Respiratory issues, such as a cough that produces a significant amount of mucus, a persistent 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 severely high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have or have had in the past
This information will help your doctor determine whether it is safe for you to take this medication and ensure that it does not interact with any other medications or health conditions you have. 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 you experienced, including any symptoms that occurred.
Respiratory issues, such as a cough that produces a significant amount of mucus, a persistent 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 severely high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have or have had in the past
This information will help your doctor determine whether it is safe for you to take this medication and ensure that it does not interact with any other medications or health conditions you have. 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 this medication for a child, note that different brands may be suitable for different age groups. Therefore, it is crucial to consult with your doctor before administering this drug to a child.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss this with your doctor. This conversation will help you understand the benefits and risks associated with this medication for both you and your baby, allowing for an informed decision.
When considering this medication for a child, note that different brands may be suitable for different age groups. Therefore, it is crucial to consult with your doctor before administering this drug to a child.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss this with your doctor. This conversation will help you understand the benefits and risks associated with this medication for both you and your baby, allowing for an informed decision.
Overdose Information
Overdose Symptoms:
- Nausea, vomiting, stomach pain
- Dizziness, drowsiness, confusion
- Nervousness, restlessness, irritability
- Insomnia, hallucinations
- Rapid heart rate, palpitations, high blood pressure
- Difficulty urinating
- Respiratory depression (rare, with very high dextromethorphan doses)
- Serotonin syndrome (agitation, confusion, rapid heart rate, fever, sweating, muscle rigidity, tremors)
What to Do:
Immediately call a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOIs) - risk of hypertensive crisis, serotonin syndrome
Major Interactions
- Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, tramadol, bupropion, St. John's Wort) - risk of serotonin syndrome with dextromethorphan
- Beta-blockers (non-selective) - risk of unopposed alpha-adrenergic effects leading to hypertension and bradycardia with phenylephrine
- Tricyclic Antidepressants (TCAs) - may potentiate pressor effects of phenylephrine
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased risk of vasoconstriction with phenylephrine
Moderate Interactions
- Alpha-adrenergic agonists (e.g., other decongestants, appetite suppressants) - additive pressor effects with phenylephrine
- Antihypertensives (e.g., ACE inhibitors, ARBs, diuretics) - phenylephrine may reduce their effect
- Digoxin - increased risk of arrhythmias with phenylephrine
- Linezolid - MAOI activity, risk of hypertensive crisis/serotonin syndrome
Minor Interactions
- Alcohol and other CNS depressants - additive CNS depression with dextromethorphan (though minimal at OTC doses)
Monitoring
Routine Monitoring
Symptom relief (cough, congestion, mucus)
Frequency: Daily, as needed
Target: Improved comfort, reduced symptoms
Action Threshold: If symptoms worsen or persist beyond 7 days, or are accompanied by fever, rash, or persistent headache, discontinue and consult a physician.
Adverse effects (e.g., dizziness, nervousness, insomnia, elevated blood pressure)
Frequency: Daily, as needed
Target: Absence of significant adverse effects
Action Threshold: If severe or persistent adverse effects occur, discontinue and seek medical attention.
Symptom Monitoring
- Cough frequency and severity
- Nasal congestion
- Mucus thickness and production
- Sleep disturbances
- Nervousness, dizziness, headache
- Heart palpitations, increased blood pressure (especially in susceptible individuals)
Special Patient Groups
Pregnancy
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 if possible.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
Phenylephrine should be used with caution due to potential for vasoconstriction affecting uterine blood flow. Dextromethorphan and guaifenesin generally considered low risk but consult physician.
Lactation
L3 (Moderately Safe). Small amounts of ingredients may pass into breast milk. Use with caution and observe infant for adverse effects (e.g., irritability, drowsiness). Consult a healthcare provider.
Infant Risk:
Low to moderate risk. Potential for irritability or drowsiness in infant with dextromethorphan. Phenylephrine may reduce milk supply.
Pediatric Use
Not recommended for children under 12 years of age without physician consultation. Over-the-counter cough and cold products are not recommended for children under 4 years of age due to potential for serious side effects. Always follow age-specific dosing instructions on the product label.
Geriatric Use
Use with caution in elderly patients, especially those with pre-existing conditions such as hypertension, heart disease, glaucoma, or benign prostatic hyperplasia (BPH), due to the phenylephrine component. Start with the lowest effective dose and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Advise patients to stay well-hydrated to maximize the expectorant effect of guaifenesin.
- Caution patients about potential for drowsiness (though less common with dextromethorphan than other antitussives) and stimulant effects (nervousness, insomnia) from phenylephrine.
- Emphasize the importance of not exceeding recommended doses, especially due to the phenylephrine component which can cause significant cardiovascular effects.
- Remind patients to check other OTC medications for similar ingredients to avoid accidental overdose.
- This product is for symptomatic relief and does not treat the underlying cause of cough or congestion.
Alternative Therapies
- Single-ingredient guaifenesin for expectorant effect
- Single-ingredient dextromethorphan for cough suppression
- Single-ingredient phenylephrine or pseudoephedrine for decongestion
- Non-pharmacological treatments: saline nasal sprays, humidifiers, honey for cough, rest, fluids.
Cost & Coverage
Average Cost:
Varies widely, typically $10-$25 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often not covered by prescription plans as it's an OTC product, but may be eligible for FSA/HSA.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.