Guaifenesin ER 1200mg 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
Category C
FDA Approved
Jul 2002
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. It's used to relieve chest congestion caused by colds, bronchitis, or 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. Take the medication as directed, with or without food. If it causes stomach upset, take it with food to help minimize discomfort. 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 the 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 by your doctor or pharmacist. If you have questions about disposing of medications, consult your pharmacist, who may be aware of 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 is 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 advised by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication as directed, with or without food. If it causes stomach upset, take it with food to help minimize discomfort. 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 the 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 by your doctor or pharmacist. If you have questions about disposing of medications, consult your pharmacist, who may be aware of 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 is 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 advised by your doctor.
Lifestyle & Tips
- Drink plenty of water and other fluids to help thin mucus and improve the drug's effectiveness.
- Avoid irritants like smoke, dust, and allergens that can worsen respiratory symptoms.
- Do not crush, chew, or break extended-release tablets; swallow them whole.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1200 mg every 12 hours
Dose Range:
1200 - 2400 mg
Condition-Specific Dosing:
maximumDailyDose:
Do not exceed 2400 mg in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age for 1200mg ER formulation
Adolescent:
12 years and older: 1200 mg every 12 hours
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Dialysis:
Not significantly removed by dialysis; no specific adjustment recommended
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Pharmacology
Mechanism of Action
Guaifenesin is an expectorant that works by increasing the volume and decreasing the viscosity of secretions in the respiratory tract. This action helps to loosen phlegm and bronchial secretions, making coughs more productive and facilitating the removal of mucus from the airways.
Pharmacokinetics
Absorption:
Bioavailability:
Well absorbed
Tmax:
Approximately 2-4 hours (for extended-release)
FoodEffect:
Minimal; can be taken with or without food
Distribution:
Vd:
Not widely reported, but distributes into respiratory tract fluids
ProteinBinding:
Low (approximately 10%)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1 hour (for immediate release; extended-release provides prolonged therapeutic effect)
Clearance:
Rapid
ExcretionRoute:
Primarily renal (as inactive metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
Not precisely defined for expectorant effect, but related to Tmax
DurationOfAction:
12 hours (for extended-release formulation)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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. However, many people do not experience any side effects or only have mild ones. If you have any 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 can provide medical advice on managing side effects.
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 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. However, many people do not experience any side effects or only have mild ones. If you have any 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 can provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Cough that lasts more than 7 days or comes back
- Fever, rash, or persistent headache
- Symptoms that worsen or do not improve after 7 days of use
- Signs of 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.
If you have a cough that produces a significant amount of mucus, a persistent cough caused by smoking or exposure to smoke, or pre-existing lung conditions like asthma or emphysema.
This list is not exhaustive, and it is crucial to disclose all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments and health conditions.
Remember, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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.
If you have a cough that produces a significant amount of mucus, a persistent cough caused by smoking or exposure to smoke, or pre-existing lung conditions like asthma or emphysema.
This list is not exhaustive, and it is crucial to disclose all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments and health conditions.
Remember, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 drug may be approved for use in children of various ages, so it is crucial to consult with your doctor before administering this medication 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
- Abdominal pain
- Kidney stones (with very high, chronic doses)
What to Do:
Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Minor Interactions
- May interfere with certain laboratory tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA), leading to false positive results.
Monitoring
Symptom Monitoring
- Effectiveness in reducing chest congestion and making coughs more productive
- Resolution of underlying respiratory symptoms
- Adverse effects such as nausea, vomiting, dizziness, headache, or rash
Special Patient Groups
Pregnancy
Generally considered low risk, but use with caution and only if clearly needed after consulting a healthcare provider. Limited human data available.
Trimester-Specific Risks:
First Trimester:
Limited data; generally considered low risk but avoid if possible unless medically necessary.
Second Trimester:
Generally considered safe based on limited data.
Third Trimester:
Generally considered safe based on limited data.
Lactation
Generally considered compatible with breastfeeding. Guaifenesin is excreted in breast milk in small amounts. Monitor infant for potential drowsiness or gastrointestinal upset.
Infant Risk:
Low
Pediatric Use
The 1200mg extended-release formulation is not recommended for children under 12 years of age. Lower dose formulations or different dosage forms (e.g., liquid) are available for younger children, but always consult a pediatrician.
Geriatric Use
No specific dose adjustment is typically needed. Use with caution in elderly patients with pre-existing conditions, though guaifenesin is generally well-tolerated.
Clinical Information
Clinical Pearls
- Advise patients to drink plenty of water throughout the day to enhance the expectorant effect of guaifenesin.
- Guaifenesin helps to thin mucus and make coughs more productive; it is not a cough suppressant.
- Extended-release tablets must be swallowed whole and should not be crushed, chewed, or broken, as this can lead to rapid release of the drug and potential adverse effects.
- Inform patients that guaifenesin may cause false positive results for certain laboratory tests, such as those for 5-HIAA and VMA.
Alternative Therapies
- N-acetylcysteine (prescription mucolytic)
- Adequate hydration (non-pharmacologic)
- Steam inhalation
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Often Tier 1 or 2 for generics; may be covered by FSA/HSA for OTC
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 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 medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.