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.

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.

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

• 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.

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

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

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

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

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

There is limited information regarding Contraindication of Simethicone

• 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.

There is limited information regarding Adverse Reactions of Simethicone.

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

There is limited information regarding Drug Interactions of Simethicone.

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.

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

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

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

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

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

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

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

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

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

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

• Oral

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

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

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.

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

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

There is limited information regarding Pharmacodynamics of Simethicone

There is limited information regarding Pharmacokinetics of Simethicone

There is limited information regarding nonclinical toxicology of Simethicone

There is limited information regarding clinical studies of Simethicone

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

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

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GERICARE

NDC 57896-791-01

CHEWABLE

SIMETHICONE

TABLETS USP, 80mg

FOR GAS DISTRESS

MINT FLAVOR

100 Tablets

80 mg each

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

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

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

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

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