Simethicone

Simethicone
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Simethicone is a antiflatulent, diagnostic and gastrointestinal agent that is FDA approved for the treatment of excessive upper gastrointestinal gas. Common adverse reactions include darrhea, nausea, regurgitation and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Relieves pressure and bloating commonly referred to as gas.
• Ultrasonography

Dosing Information

• Chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. Do not exceed 6 tablets per day unless directed by a physician.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Simethicone in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Simethicone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Simethicone FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Simethicone in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Simethicone in pediatric patients.

Contraindications

There is limited information regarding Contraindication of Simethicone

Warnings

• When using this product • do not take more than directed, except under the advice of a doctor

• If pregnant or breast feeding, ask a health professional before use.

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Adverse Reactions of Simethicone.

Postmarketing Experience

There is limited information regarding Adverse Reactions reported from Post Experience of Simethicone.

Drug Interactions

There is limited information regarding Drug Interactions of Simethicone.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Simethicone in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Simethicone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Simethicone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Simethicone in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Simethicone in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Simethicone in geriatric settings.

Gender

There is no FDA guidance on the use of Simethicone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Simethicone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Simethicone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Simethicone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Simethicone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Simethicone in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Simethicone Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Simethicone and IV administrations.

Overdosage

There is limited information regarding Simethicone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Simethicone
Systematic (IUPAC) name
Poly(dimethylsiloxane), silicon dioxide
Identifiers
CAS number	8050-81-5
ATC code	A03AX13
PubChem	6433516
Chemical data
Formula	(C2H6OSi)n · (SiO2)m
Mol. mass	variable
Pharmacokinetic data
Bioavailability	not absorbed from the gut
Protein binding	N/A
Metabolism	N/A
Half life	N/A
Excretion	N/A
Therapeutic considerations
Pregnancy cat.	?
Legal status	OTC(US)
Routes	Oral

Mechanism of Action

There is limited information regarding Simethicone Mechanism of Action in the drug label.

Structure

There is limited information regarding Simethicone Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Simethicone

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Simethicone

Nonclinical Toxicology

There is limited information regarding nonclinical toxicology of Simethicone

Clinical Studies

There is limited information regarding clinical studies of Simethicone

How Supplied

There is limited information regarding Simethicone How Supplied in the drug label.

Storage

• Store at room temperature, 15°C - 30°C (59˚F - 86˚F)
• Package not child resistant

Images

Drug Images

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Package and Label Display Panel

PACKAGE LABEL

GERICARE

NDC 57896-791-01

CHEWABLE

SIMETHICONE

TABLETS USP, 80mg

FOR GAS DISTRESS

MINT FLAVOR

100 Tablets

80 mg each

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Simethicone Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Simethicone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Mylicon
• Gas-X
• Maalox Anti-Gas
• Mylanta Gas
• Genasyme
• Mytab Gas
• Phazyme
• Alka-Seltzer Anti-Gas

Look-Alike Drug Names

There is limited information regarding Simethicone Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.