Guaifenesin 600mg ER Tablets
It is used to thin mucus so it can be taken from the body by coughing.
Drug Class
Expectorant
Pharmacologic Class
Expectorant
Pregnancy Category
C
FDA Approved
Jul 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Guaifenesin is an expectorant that helps thin and loosen mucus in your lungs and airways, making it easier to cough up. This can help relieve chest congestion caused by colds, bronchitis, and other breathing illnesses.
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. Swallow the medication whole; do not chew, break, or crush it.
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 have access to 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. Swallow the medication whole; do not chew, break, or crush it.
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 have access to 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, juice) to help loosen mucus.
- Avoid smoking and exposure to secondhand smoke, which can irritate airways.
- Use a humidifier to add moisture to the air, which can help soothe irritated airways.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
600 mg to 1200 mg orally every 12 hours
Dose Range:
600 - 1200 mg
Condition-Specific Dosing:
maximumDailyDose:
2400 mg per 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age for extended-release formulations.
Adolescent:
12 years and older: 600 mg to 1200 mg orally every 12 hours, not to exceed 2400 mg per 24 hours.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended; use with caution in severe impairment.
Severe:
Use with caution; monitor for adverse effects. No specific dose adjustment guidelines.
Dialysis:
Not significantly removed by dialysis. No specific dose adjustment recommended, but use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended; use with caution in severe impairment.
Severe:
Use with caution; monitor for adverse effects. No specific dose adjustment guidelines.
Pharmacology
Mechanism of Action
Guaifenesin is an expectorant that works by increasing the volume and decreasing the viscosity of secretions in the trachea and bronchi. This facilitates the removal of tenacious mucus by ciliary action and coughing, making coughs more productive.
Pharmacokinetics
Absorption:
Bioavailability:
Well absorbed orally.
Tmax:
Extended-release: Approximately 2-3 hours (for initial peak).
FoodEffect:
Minimal effect; can be taken with or without food.
Distribution:
Vd:
Not readily available, but widely distributed.
ProteinBinding:
Low (approximately 10%).
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1 hour (for immediate-release; effective duration extended by ER formulation).
Clearance:
Not readily available.
ExcretionRoute:
Renal excretion of metabolites.
Unchanged:
Less than 1% of the dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (for immediate-release; sustained effect for ER).
PeakEffect:
Not precisely defined for ER, sustained release over 12 hours.
DurationOfAction:
Up to 12 hours (for extended-release formulation).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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. 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.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice about side effects.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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. 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.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Cough lasting more than 7 days or recurring
- Cough accompanied by fever, rash, or persistent headache
- Worsening symptoms or new symptoms developing
- Signs of allergic reaction (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 and its symptoms.
If you experience 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.
This list is not exhaustive, and it is crucial to discuss all potential interactions with your doctor. Therefore, please inform your doctor and pharmacist about:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have, as they may affect the safety of taking this medication.
To ensure your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination with all your other medications and health conditions.
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 experience 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.
This list is not exhaustive, and it is crucial to discuss all potential interactions with your doctor. Therefore, please inform your doctor and pharmacist about:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have, as they may affect the safety of taking this medication.
To ensure your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination with all your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Be aware that different brands of this medication may be suitable for children of varying ages, so it is crucial to consult with your doctor before administering it to a child. If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss this with your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Diarrhea
- Abdominal pain
- Kidney stones (with very high, prolonged doses)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.
Drug Interactions
Minor Interactions
- May interfere with laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA) due to color interference.
Monitoring
Symptom Monitoring
- Cough frequency and productivity
- Sputum consistency and volume
- Signs of infection (fever, worsening cough, colored sputum)
- Hydration status
Special Patient Groups
Pregnancy
Guaifenesin is generally considered low risk during pregnancy, but it is classified as Pregnancy Category C. Use only if clearly needed and the benefit outweighs the potential risk. Consult a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Limited human data, but no clear evidence of teratogenicity. Use with caution.
Second Trimester:
Generally considered safer than first trimester, but still use only if necessary.
Third Trimester:
No specific risks identified, but always consult a healthcare provider.
Lactation
Guaifenesin is considered moderately safe during breastfeeding (L3). It is excreted into breast milk in small amounts. Monitor the infant for potential adverse effects like drowsiness or gastrointestinal upset, though unlikely.
Infant Risk:
Low
Pediatric Use
Extended-release guaifenesin is generally not recommended for children under 12 years of age. Always consult a pediatrician for appropriate dosing and formulation for younger children.
Geriatric Use
No specific dose adjustments are typically needed for elderly patients. However, elderly patients may be more sensitive to the effects of drugs and may have underlying renal or hepatic impairment, so use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Advise patients to drink plenty of water to maximize the expectorant effect of guaifenesin.
- Extended-release tablets should be swallowed whole and not crushed, chewed, or broken.
- Guaifenesin is for symptomatic relief of chest congestion and productive cough; it does not treat the underlying cause of the cough.
- If cough persists for more than 7 days, worsens, or is accompanied by fever, rash, or persistent headache, patients should seek medical attention.
Alternative Therapies
- N-acetylcysteine (mucolytic, prescription only)
- Hydration alone (non-pharmacological)
- Steam inhalation (non-pharmacological)
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.