Simethicone

Pharmacologic Category

Antiflatulent

Dosing: Adult

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

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There is no dosage adjustment provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to the drug not being systemically absorbed.

Dosing: Hepatic Impairment: Adult

There is no dosage adjustment provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to the drug not being systemically absorbed.

Dosing: Pediatric

Note: Refer to product specific labeling for approved pediatric ages.

Gas pain/ gastrointestinal discomfort:

Infants and Children <2 years weighing <10.9 kg: Oral: 20 mg 4 times daily as needed after meals and at bedtime. Maximum daily dose: 240 mg/24 hours

Children <2 years weighing ≥10.9 kg and Children ≥2 to <12 years: Oral: 40 mg 4 times daily as needed after meals and at bedtime. Maximum daily dose: 480 mg/24 hours

Children ≥12 years and Adolescents: 40 to 125 mg 4 times daily as needed after meals and at bedtime; with some formulations, may administer a single 250 mg dose if needed; maximum daily dose: 500 mg/24 hours

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; dosage adjustment unlikely due to the drug not being systemically absorbed.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; dosage adjustment unlikely due to the drug not being systemically absorbed.

Use: Labeled Indications

Gas retention: Relief of pressure, bloating, fullness, and discomfort of gastrointestinal gas.

* See Uses in AHFS Essentials for additional information.

Administration: Oral

Chewable tablet: Chew thoroughly and swallow

Suspension (drops): Shake well before using; may mix with 30 mL water or other liquids.

Strips: Allow to dissolve on tongue.

Administration: Pediatric

Oral:

Chewable tablet: Chew thoroughly and swallow.

Suspension (drops): Shake well before using. Fill enclosed dropper to recommended dosage level and dispense slowly in mouth towards inner cheek. May mix with 30 mL water, infant formula, or other liquids.

Strips: Allow to dissolve on tongue.

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F). Protect from moisture. Avoid high humidity and excessive heat.

Oral suspension: Do not freeze.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to ease too much gas in the GI (gastrointestinal) tract.

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Contraindications

Hypersensitivity to simethicone or any component of the formulation

Warnings/Precautions

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

Before treating excess gas or pain due to gas accumulation, a thorough evaluation must be made to determine cause since many bowel diseases may present with flatulence and bloating.

Pregnancy Considerations

Simethicone is not absorbed systemically following oral administration. Systemic absorption would be required in order for simethicone to cross the placenta and reach the fetus (Mahadevan 2006).

Breast-Feeding Considerations

Due to lack of systemic absorption, simethicone is not expected to be excreted in breast milk (Hagemann 1998).

Briggs' Drugs in Pregnancy & Lactation

• Simethicone

Adverse Reactions

No data reported

* See Cautions in AHFS Essentials for additional information.

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

There are no known significant interactions.

Food Interactions

Avoid carbonated beverages and gas-forming foods.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Gas Relief Extra Strength: 125 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Gas Relief Ultra Strength: 180 mg [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

Gas Relief Ultra Strength: 180 mg [contains fd&c yellow #6 (sunset yellow)]

Gas-X Extra Strength: 125 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Gas-X Ultra Strength: 180 mg [contains fd&c yellow #6 (sunset yellow)]

Phazyme: 180 mg

Phazyme Maximum Strength: 250 mg [contains brilliant blue fcf (fd&c blue #1)]

Phazyme Ultra Strength: 180 mg [contains fd&c yellow #6 (sunset yellow)]

Generic: 125 mg, 180 mg

Liquid, Oral:

Gas-X Infant Drops: 20 mg/0.3 mL (30 mL) [alcohol free, no artificial color(s), no artificial flavor(s), saccharin free; contains polyethylene glycol, sodium benzoate]

Strip, Oral:

Gas-X Childrens: 40 mg (16 ea) [contains alcohol, usp, fd&c red #40; sweet cinnamon flavor]

Gas-X Extra Strength: 62.5 mg (18 ea [DSC], 30 ea [DSC]) [contains alcohol, usp, brilliant blue fcf (fd&c blue #1); peppermint flavor]

Gas-X Extra Strength: 62.5 mg (18 ea) [contains alcohol, usp, fd&c red #40]

Suspension, Oral:

Gas Relief: 20 mg/0.3 mL (30 mL) [dye free; contains sodium benzoate; fruit flavor]

Gas Relief Infants: 20 mg/0.3 mL (30 mL) [dye free; contains sodium benzoate]

Infants Gas Relief: 20 mg/0.3 mL (30 mL) [contains sodium benzoate]

Infants Simethicone: 20 mg/0.3 mL (30 mL) [alcohol free, no artificial color(s), no artificial flavor(s), saccharin free; contains polyethylene glycol, sodium benzoate]

Generic: 40 mg/0.6 mL (30 mL)

Tablet Chewable, Oral:

Gas Relief: 80 mg [lactose free]

Gas Relief Extra Strength: 125 mg [contains fd&c red #40 aluminum lake]

Gas Relief Extra Strength: 125 mg [lactose free; contains fd&c yellow #10 aluminum lake]

Gas Relief Maximum Strength: 125 mg [DSC] [scored; lactose free; spearmint flavor]

Gas-X: 80 mg [DSC]

Gas-X: 80 mg [scored; peppermint creme flavor]

Gas-X Extra Strength: 125 mg

Gas-X Extra Strength: 125 mg [scored; peppermint creme flavor]

Gas-X Extra Strength: 125 mg [contains fd&c yellow #10 aluminum lake; peppermint creme flavor]

Gas-X Extra Strength: 125 mg [contains soy protein]

Gas-X Extra Strength: 125 mg [contains soy protein; cherry cream flavor]

Mi-Acid Gas Relief: 80 mg

Mytab Gas: 80 mg [DSC] [peppermint flavor]

Mytab Gas Maximum Strength: 125 mg [DSC] [scored; peppermint flavor]

Phazyme: 125 mg [cool mint flavor]

Phazyme: 125 mg [contains aspartame; cool mint flavor]

Generic: 80 mg, 125 mg

Anatomic Therapeutic Chemical (ATC) Classification

• A03AX13

Generic Available (US)

May be product dependent

Pricing: US

Capsules (Gas-X Extra Strength Oral)

125 mg (per each): $0.20

Capsules (Gas-X Ultra Strength Oral)

180 mg (per each): $0.31

Capsules (Phazyme Maximum Strength Oral)

250 mg (per each): $0.29

Capsules (Phazyme Oral)

180 mg (per each): $0.20

Capsules (Phazyme Ultra Strength Oral)

180 mg (per each): $0.24

Capsules (Simethicone Oral)

125 mg (per each): $0.15

180 mg (per each): $0.05 - $0.11

Chewable (Gas-X Extra Strength Oral)

125 mg (per each): $0.25

Chewable (Gas-X Oral)

80 mg (per each): $0.14

Chewable (Phazyme Oral)

125 mg (per each): $0.19

Chewable (Simethicone Oral)

80 mg (per each): $0.02 - $0.18

125 mg (per each): $0.05

Liquid (Gas-X Infant Drops Oral)

20 mg/0.3 mL (per mL): $0.28

Strip (Gas-X Childrens Oral)

40 mg (per each): $0.34

Strip (Gas-X Extra Strength Oral)

62.5 mg (per each): $0.24

Suspension (Simethicone Oral)

40 mg/0.6 mL (per mL): $0.24

Tablets (Bicarsim Forte Oral)

125 mg (per each): $0.40

Tablets (Bicarsim Oral)

80 mg (per each): $0.33

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Decreases the surface tension of gas bubbles thereby disperses and prevents gas pockets in the GI system

Pharmacodynamics/Kinetics

Excretion: Feces

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Activated Dimethicone; Activated Methylpolysiloxane

References

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Gas Relief (simethicone) [prescribing information]. Livoria, MI: Rugby Laboratories; October 2018.

Gas Relief Extra Strength (simethicone) [prescribing information]. Livoria, MI: Rugby Laboratories; October 2018.

Gas Relief Maximum Strength (simethicone) [prescribing information]. Livoria, MI: Rugby Laboratories; May 2014.

Gas-X Extra Strength Chewables (simethicone) [prescribing information]. Parsippany, NJ: Novartis Consumer Health Inc; received March 2018.

Gas-X Extra Strength Thin Strips (simethicone) [prescribing information]. Parsippany, NJ: Novartis Consumer Health Inc; 2008.

Gas-X Extra Strength (simethicone) [prescribing information]. Parsippany, NJ: Novartis Consumer Health, Inc; October 2008.

Gas-X Regular Strength (simethicone) [prescribing information]. Parsippany, NJ: Novartis Consumer Health, Inc; October 2008.

Good Sense Simethicone Infants emulsion [prescribing information]. Allegan MI: Perrigo; July 2014.

Hagemann TM, "Gastrointestinal Medications and Breastfeeding," J Hum Lact, 1998, 14(3):259-62.[PubMed 10205441]

"Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Little Remedies Gas Relief Drops (simethicone) [prescribing information].

Mahadevan U and Kane S, "American Gastroenterological Association Institute Technical Review on the Use of Gastrointestinal Medications in Pregnancy," Gastroenterology, 2006, 131(1):283-311.[PubMed 16831611]

Mylanta Chewable Mini-Tablets (simethicone) [prescribing information]. McNeil Consumer Pharmaeuticals Company.

Mylicon Drops (simethicone) [prescribing information]. McNeil Consumer Pharmaeuticals Company.

Pedia Care Infants Gas Relief Drops (simethicone) [prescribing information].

Phazyme capsules (simethicone 180 mg) [prescribing information]. C.B. Fleet Company, Inc; December 2014.

Phazyme capsules (simethicone 250 mg) [prescribing information]. C.B. Fleet Company, Inc; June 2014.

Simethicone solution/drops [prescribing information]. Huntsville, AL: Qualitest Pharmaceuticals; May 2012.

Simethicone tablets [prescribing information]. Brooklyn, NY: Geri-Care Pharmaceuticals Corp; December 2012.

Simethicone tablets [prescribing information]. Valley Stream, NY: Reliable 1 Laboratories LLC; July 2015.

Brand Names: International

Aero-Red (ES); Aeropac (BD, LK); Aerox (PE); AF adult (GT); AF infantil (GT); Air-x (VN); Anaflat (CR, DO, GT, HN, NI, PA, SV); Antiflat (AT); Antigasol (PY); Baby Rest Drops (EG); Banflax (PY); Bloatstop (BD); Bobothic (UA); Cuplaton (UA); Deflat (AE, JO, QA, SA); Degas (JO, TH); Dentinox (EG); Dentinox Colic (IE); Digesta (EC); Disflatyl (AE, AT, BH, CH, EG, FI, JO, KW, LB, PH, QA, RU, SA, SG, UA); Espumisan (BG, CN, CZ, DE, EE, VN); Flagass (BR); Flapex (CL); Flaticon (QA); Flatunil (BD); Gaseovet (EC); Gasocol (KR); Gassi (TH); Gastulen (ID); Gastyl (MY); Gazgo (LK); Gazim X (IL); Gazix (JO); Infacol (AE, CY, IE, JO, KW, LB); Infacol Wind Drops (AU); Inflacol (UA); Lefaxin (AT); Liberan (MX); Minifom (FI, NO, SE); Mylom (TH); Neogasol (CL); Paraflat (CR, DO, GT, HN, NI, PA, SV); Phazin (TW); Restime (PH); Salinal (BH); Siligas (CO); Simet (BD); Simethicone (PL)

Last Updated 2/27/20