Simethicone

Simethicone allows gas bubbles in the stomach and intestines to come together more easily, which allows for easier passage of gas.

Simethicone is used to relieve painful pressure caused by excess gas in the stomach and intestines. Simethicone is for use in babies, children, and adults.

Simethicone may also be used for purposes not listed in this medication guide.

Since simethicone is used on an as needed basis, you are not likely to miss a dose. Do not use more of this medication than is directed.

Ask a doctor or pharmacist before using any other stomach medicine or antacid. Simethicone is contained in many combination medicines. Taking certain products together can cause you to get too much simethicone.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with simethicone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Administration

Oral Administration

Administer orally after meals and at bedtime, usually in up to 4 divided doses daily; infant drops (oral suspension) can be administered in up to 12 doses daily.a b

Chew thoroughly before swallowing.a

Generally used in infants.b Shake drops well before use; use dosing device provided by manufacturer for measurement of the dose.b

Dose may be mixed with 1 ounce cool water, infant formula, or other suitable liquids prior to administration.b

Place strips on tongue to dissolve.g

Dosage

Pediatric Patients

Usual dosage in children >12 years of age: 40–125 mg 4 times daily as needed after meals and at bedtime.a

Self-medication in children <2 years of age (<10.9 kg): 20 mg (0.3 mL) as needed after meals and at bedtime as oral drops; do not exceed 12 doses (i.e., 240 mg) daily.b

Self-medication in children 2–12 years of age (>10.9 kg): 40 mg as needed after meals and at bedtime; do not exceed 12 doses (i.e., 480 mg) daily.b

Self-medication in children >12 years of age: 40–125 mg as needed after meals and at bedtime; do not exceed 500 mg daily.a

Adults

Usual dosage: 40–125 mg 4 times daily as needed after meals and at bedtime.a

Self-medication: 40a –250c mg as needed after meals and at bedtime; do not exceed 500 mg daily.a 105

67 mg as a single dose of oral suspension, in 2.5 mL of water.a

Prescribing Limits

Pediatric Patients

Self-medication in children <2 years of age (weight <10.9 kg): Maximum 12 doses (i.e., 240 mg) daily.b

Self-medication in children 2–12 years of age (weight >10.9 kg): Maximum 12 doses (i.e., 480 mg) daily.b

Self-medication in children >12 years of age: Maximum 500 mg daily.a

Adults

Self-medication: Maximum 500 mg daily.a 105

Special Populations

No special population dosage recommendations at this time.a

Warnings/Precautions

General Precautions

Simethicone is apparently nontoxic; no adverse effects reported.a

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Category C.d

Distribution into milk not expected; simethicone not orally absorbed.d

Safety information in infants and children limited; not recommended for treatment of infant colic.a

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Simethicone is also commercially available in combination with antacids, antispasmodics, and digestants.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

• Gas Free Extra Strength [OTC] [DSC]
• Gas Relief Extra Strength [OTC]
• Gas Relief Maximum Strength [OTC]
• Gas Relief Ultra Strength [OTC]
• Gas Relief [OTC]
• Gas-X Childrens [OTC]
• Gas-X Extra Strength [OTC]
• Gas-X Infant Drops [OTC]
• Gas-X Ultra Strength [OTC]
• Gas-X [OTC]
• GasAid [OTC] [DSC]
• Infants Gas Relief [OTC]
• Infants Simethicone [OTC]
• Mi-Acid Gas Relief [OTC]
• Mytab Gas Maximum Strength [OTC]
• Mytab Gas [OTC]
• Phazyme Maximum Strength [OTC]
• Phazyme Ultra Strength [OTC]
• Phazyme [OTC]

Gas retention: Oral: Usual dose: 40 to 125 mg 4 times daily as needed after meals and at bedtime; may administer single doses of up to 160 to 500 mg after meals or at bedtime, not to exceed a maximum daily dose of 500 mg/day