Simethicone Infants Drops
It is used to ease too much gas in the GI (gastrointestinal) tract.
Drug Class
Antiflatulent
Pharmacologic Class
Surfactant; Defoaming Agent
Pregnancy Category
Not formally assigned (minimal systemic absorption, generally considered safe)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Simethicone is an anti-gas medicine that helps relieve painful pressure, bloating, and fullness caused by excess gas in the stomach and intestines. It works by breaking up gas bubbles, making them easier to pass.
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 this medication after meals and at bedtime, or as directed by your doctor. When taking the liquid form, measure the dose carefully using the measuring device that comes with the medication. You can place the medication directly in your mouth, towards your cheek, or mix it with formula, water, or another liquid. Remember to shake the medication well before use.
Storing and Disposing of Your Medication
Store this 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, take a 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 normal 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. Take this medication after meals and at bedtime, or as directed by your doctor. When taking the liquid form, measure the dose carefully using the measuring device that comes with the medication. You can place the medication directly in your mouth, towards your cheek, or mix it with formula, water, or another liquid. Remember to shake the medication well before use.
Storing and Disposing of Your Medication
Store this 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, take a 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 normal 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
- For infants, ensure proper feeding techniques to minimize air swallowing (e.g., proper latch for breastfeeding, correct bottle nipple size, burping frequently).
- Avoid foods known to cause gas in the mother (if breastfeeding) or in the infant (if on solids).
- Gentle abdominal massage or 'bicycle' leg movements can help infants pass gas.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
40-125 mg orally after meals and at bedtime as needed
Dose Range:
40 - 125 mg
Condition-Specific Dosing:
Maximum daily dose:
500 mg
Pediatric Dosing
Neonatal:
20 mg (0.3 mL of 66.7 mg/mL drops) orally 4 times daily as needed, or as directed by physician. Consult physician for infants under 2 years.
Infant:
20 mg (0.3 mL of 66.7 mg/mL drops) orally 4 times daily as needed, or as directed by physician. Maximum 12 doses/day.
Child:
2-12 years: 40 mg (0.6 mL of 66.7 mg/mL drops) orally 4 times daily as needed. Maximum 12 doses/day.
Adolescent:
12 years and older: 40-125 mg orally after meals and at bedtime as needed. Maximum 500 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No considerations, not systemically absorbed
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Simethicone is an antiflatulent that acts in the stomach and intestines to change the surface tension of gas bubbles. This causes the bubbles to coalesce, allowing for easier passage of gas (belching or passing flatus). It does not prevent the formation of gas.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (<0.1%)
Tmax:
Not applicable (not systemically absorbed)
FoodEffect:
Administered after meals for optimal effect on gas formed during digestion, but not for absorption purposes.
Distribution:
Vd:
Not applicable (not systemically absorbed)
ProteinBinding:
Not applicable (not systemically absorbed)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (not systemically absorbed)
Clearance:
Not applicable (not systemically absorbed)
ExcretionRoute:
Fecal excretion
Unchanged:
>99%
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes to hours)
PeakEffect:
Not precisely defined due to local action
DurationOfAction:
Variable, depends on continued gas production
Safety & Warnings
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, as they may be signs of a severe and potentially life-threatening reaction:
* 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
It's essential to remember that all medications can cause side effects, although many people may not experience any or may only have mild symptoms. If you have any side effects that bother you or persist, contact your doctor for advice.
Reporting Side Effects
If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Remember, this is not an exhaustive list of possible side effects, and your doctor can provide guidance on managing any symptoms you may experience.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
* 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
It's essential to remember that all medications can cause side effects, although many people may not experience any or may only have mild symptoms. If you have any side effects that bother you or persist, contact your doctor for advice.
Reporting Side Effects
If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Remember, this is not an exhaustive list of possible side effects, and your doctor can provide guidance on managing any symptoms you may experience.
Seek Immediate Medical Attention If You Experience:
- Symptoms worsen or do not improve after several days of use.
- Fever, vomiting, diarrhea, or blood in stool occur (these may indicate a more serious condition).
- Severe or persistent abdominal pain.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all 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 you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all 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 of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are currently breast-feeding, be sure to discuss this with your doctor. This conversation will help you understand the potential benefits and risks of this medication for both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Simethicone is considered very safe with extremely low toxicity due to minimal systemic absorption. Overdose is unlikely to cause serious harm.
- Possible mild gastrointestinal upset (e.g., loose stools) if very large amounts are ingested, but this is rare.
What to Do:
Due to its safety profile, specific antidote or aggressive treatment is generally not required. Discontinue use. If concerned, contact a poison control center (Call 1-800-222-1222) or seek medical attention.
Drug Interactions
Moderate Interactions
- Thyroid hormones (e.g., Levothyroxine)
Monitoring
Symptom Monitoring
- Reduction in gas, bloating, and abdominal discomfort
- Infant fussiness or crying related to gas
- Frequency and severity of gas episodes
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy due to negligible systemic absorption. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk
Second Trimester:
Low risk
Third Trimester:
Low risk
Lactation
Considered safe for use during breastfeeding. Simethicone is not absorbed systemically by the mother, so it is not excreted into breast milk and poses no risk to the nursing infant.
Infant Risk:
Very low risk (L1)
Pediatric Use
Simethicone infant drops are specifically formulated and dosed for infants and children. It is widely used and considered safe for gas relief in this population. Always follow age-appropriate dosing instructions and consult a pediatrician for infants under 2 years or if symptoms persist.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients due to minimal systemic absorption. Safe for use.
Clinical Information
Clinical Pearls
- Simethicone works by physically breaking down gas bubbles, not by preventing gas formation or absorption. It is a symptomatic treatment.
- Shake the bottle well before each use to ensure even distribution of the active ingredient.
- Administer directly into the infant's mouth using the provided dropper, or mix with 1 oz of cool water, formula, or other suitable liquid.
- It can be given after meals and at bedtime, or as needed, up to the maximum daily dose.
- If gas symptoms persist or worsen, or if other concerning symptoms (e.g., fever, vomiting, blood in stool) develop, consult a healthcare professional to rule out more serious underlying conditions.
Alternative Therapies
- Dietary modifications (e.g., avoiding gas-producing foods for mother/infant)
- Probiotics (for some types of gas/colic)
- Lactase enzyme supplements (for lactose intolerance-related gas)
- Gripe water (contains various herbal ingredients, efficacy varies and safety concerns exist for some formulations)
- Physical interventions (e.g., burping, abdominal massage, 'bicycle' leg movements for infants)
Cost & Coverage
Average Cost:
$5 - $15 per 30 mL bottle of infant drops
Generic Available:
Yes
Insurance Coverage:
Generally not covered by insurance as it is an over-the-counter (OTC) medication. May be eligible for FSA/HSA.
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.