Dosage Forms
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
Pharmacology
Mechanism of Action
Decreases the surface tension of gas bubbles thereby disperses and prevents gas pockets in the GI system
Pharmacokinetics/Pharmacodynamics
Excretion
Feces
Use: Labeled Indications
Gas retention: Relief of pressure, bloating, fullness, and discomfort of gastrointestinal gas.
Contraindications
Hypersensitivity to simethicone or any component of the formulation
Dosage and Administration
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
Dosing: Geriatric
Refer to adult dosing.
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
Administration
Oral: Chewable tablet: Chew thoroughly and swallow
Oral suspension (drops): Shake well before using; may mix with 30 mL water or other liquids.
Oral strips: Allow to dissolve on tongue.
Storage
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.
Simethicone Images
Drug Interactions
There are no known significant interactions.
Adverse Reactions
No data reported
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.
Pregnancy
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).
Patient Education
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.
