Simethicone
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 | |
| ATC code | A03 |
| PubChem | |
| 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 | |
| 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
{{#ask: Page Name::Simethicone |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
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
{{#ask: Label Page::Simethicone |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.