Restime

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Restime

Property Description
Active ingredient Simethicone
Form Oral drops, tablets, capsules, suspension
Pharmacological class Antifoaming Agent / Anti-flatulent
Common use Relief from gas, bloating, and abdominal pressure
Origin Synthetic silicone-based surfactant

The Identity of Restime: Type and Pharmacological Class

Restime is an Over-The-Counter (OTC) preparation classified as a Gastrointestinal Agent, specifically holding the official designation of an antifoaming agent. Its active ingredient, Simethicone, is intended solely for oral administration. The use of Simethicone for gas relief is clinically recognized and supported by pharmacological studies.

This medication operates through a non-systemic action, meaning it is not chemically absorbed into the bloodstream or metabolized by the body. Instead, it acts entirely within the intestinal and gastric lumen before being safely excreted unchanged. This non-systemic property confirms its use as a purely physical agent, reducing concerns about systemic drug-drug interactions.


Composition and Origin of the Active Ingredient

The core component, Simethicone, is a synthetic silicone-based surfactant derived from a mixture of Dimethylpolysiloxane and Silicon Dioxide. This composition dictates its mechanism of action, which relies on altering surface tension.

Restime is provided in several common dosage forms, including oral drops, chewable tablets, capsules, and oral suspension. A distinguishing feature of many Simethicone products like Restime is the focus on a single active ingredient, offering targeted gas relief without the effects of secondary components often found in combination antacid preparations.


General Purpose: Targeting Physical Gas Pressure

The primary purpose of Restime is to provide relief from the physical discomforts caused by excessive gas, specifically bloating, gassiness, and abdominal pressure. Simethicone achieves this by functioning as a surface-active agent that disrupts the physical integrity of the numerous small, foamy gas bubbles trapped in the digestive tract.

This mechanical action causes the small bubbles to coalesce into larger gas pockets. The conclusion drawn from this is that the medicine makes it easier for the body to expel the trapped gas through natural processes, thus effectively reducing the source of physical tension and discomfort in scenarios such as post-meal gas accumulation or general abdominal pressure.

Regulatory References

  1. Simethicone - StatPearls (NIH Bookshelf)

What side effects are possible with Restime?

Possible Side Effects and Safety Information

The safety profile of Restime, which contains the active ingredient Simethicone, is fundamentally characterized by its non-systemic action. This means the substance acts locally within the gastrointestinal tract and is not chemically absorbed into the bloodstream, which greatly limits the potential for wide-ranging, systemic adverse effects.


Official Adverse Reactions and Classifications

Adverse reactions reported in regulatory sources primarily affect two major System-Organ Classes: Gastro-Intestinal Disorders and Immune System Disorders (including Skin and Subcutaneous Tissue Disorders). The frequency of many effects is often classified as Not known due to the nature of post-marketing surveillance data.

Reported adverse effects include minor gastrointestinal issues such as nausea, vomiting, and constipation.

Serious Safety Considerations

The most clinically significant safety risk is the rare occurrence of hypersensitivity reactions (allergic-type responses). These serious adverse reactions, as documented in official labeling, can include manifestations such as a rash, pruritis (itching), and localized swelling like Face Oedema or Tongue Oedema, potentially accompanied by Respiratory Difficulty.

Regulatory Safety Restrictions

Use of Restime is contraindicated in individuals with known hypersensitivity (allergy) to Simeticone or any of the excipients in the product. A high-level safety note exists concerning potential drug interactions, stating that Simethicone may impair the absorption of Levothyroxine when the two medicines are administered at the same time.

Population Safety Notes

Due to the negligible systemic absorption of Simethicone, no adverse effect on the fetus or breastfed infant is anticipated, a position reflected in official safety assessments for use during pregnancy and lactation.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Restime (Simethicone) is based on the substance’s classification as a non-systemic antifoaming agent. Simethicone is documented by health authorities as being physiologically inert and not absorbed into the bloodstream.

Overdose Manifestations and Risk

Regulatory documents state that systemic toxic effects are considered unlikely following an overdose due to the substance's lack of absorption. Accordingly, no severe or life-threatening systemic outcomes, such as cardiac or central nervous system effects, are formally listed as a direct result of overexposure. While no cases of overdose have been widely reported, theoretical gastrointestinal manifestations, specifically constipation, may occur. No specific population-based considerations for overdose severity are documented for this ingredient.

Required Emergency Actions

It is a regulatory requirement to seek medical help or contact a Poison Control Center immediately upon suspicion of overdosage. Management is defined as symptomatic and supportive and includes discontinuing the medication. No specific antidote is known for Simethicone. Urgent medical attention must also be sought if any signs of a severe allergic or hypersensitivity reaction, such as swelling or difficulty breathing, are noted.

Therapeutic Uses of Restime

What Restime Treats: Main Uses and Benefits

Restime is relevant for use in the therapeutic management of gas-related symptoms. The medication is applied across domains where additional symptomatic support for physical discomfort is needed.

Managing Physical Pressure and Functional Bloating

Restime is commonly used to help with symptoms related to physical discomfort, such as the feelings of pressure, fullness, and bloating that create noticeable physiological strain. The medication is used in conditions characterized by periods of heightened symptoms, including functional gastric disorders and cases of recurrent gassiness. It is relevant when short-term symptomatic assistance is needed to address symptom clusters that may appear suddenly or fluctuate, providing support that helps ease the overall symptom burden associated with acute or episodic changes.

“The medication is generally applied in scenarios where additional management of discomfort is required, assisting with symptoms that interfere with daily functioning.”

Commonly managed indications include functional gastric bloating, acute gassiness following meals, postoperative gas pain, and symptomatic discomfort in infant gassiness. This use contributes to improved comfort during periods of heightened symptoms and may help patients cope more steadily with symptom fluctuations.


Quick Fact: Relief for Trapped Gas Symptoms Restime helps maintain a sense of stability when symptoms are more noticeable, supporting the patient during difficult episodes of physical pressure and tension, and is considered relevant for easing abdominal discomfort across various age groups.

Eligibility and Restrictions for Use

Restime (Simethicone) is an Over-The-Counter (OTC) medication whose eligibility for use is defined by official regulatory documents, primarily focusing on age, documented allergies, and the drug's non-systemic nature.

Populations for Whom Use is Prohibited

Use is contraindicated for any individual with a known hypersensitivity or allergy to Simethicone or any of the inactive ingredients in the specific Restime formulation. This is the sole absolute contraindication listed in regulatory labeling.

Eligibility by Age and Physiological State

Population Group Regulatory Eligibility Status
Adults and Adolescents (12+ years) Permitted for standard OTC use.
Children (under 12 years) Restricted use; typically requires the advice and supervision of a doctor for appropriate administration.
Pregnant and Breastfeeding Individuals Permitted for use. Regulatory data confirms Simethicone is not systemically absorbed and is not excreted in human milk.
Renal or Hepatic Impairment Permitted for use. No restrictions are documented as the drug does not enter the bloodstream.

Eligibility may also be affected by excipient compatibility; patients with conditions like diabetes or Phenylketonuria (PKU) must check the specific formulation for components like sugar or aspartame.

What should I know about interactions with other medicines?

The interaction profile of Restime (Simethicone) is uniquely restricted due to its non-systemic nature, meaning the active ingredient is not absorbed into the bloodstream and does not engage in systemic metabolic or transporter interactions. Consequently, the officially documented interactions are limited to physical interference within the gastrointestinal tract.

Documented Pharmacokinetic Interactions

Interaction Partner Mechanistic Basis (Regulatory Statement) Interaction Outcome Classification
Levothyroxine (and other thyroid hormones) Non-systemic pharmacokinetic interference (reduced oral bioavailability/absorption) Clinically Significant (Requires timing adjustment)

Official Interaction Statements:

  • Co-administration of Restime with Levothyroxine may reduce the bioavailability and absorption of the thyroid hormone.
  • This effect is classified by government sources as a pharmacokinetic interaction that occurs locally in the gut lumen.
  • To mitigate this effect, official drug interaction summaries require a mandatory administration separation; Restime and thyroid replacement hormones must be taken at least four hours apart.

The regulatory documents focus the interaction guidance on preventing this single physical constraint. There are no known official restrictions documented regarding food, alcohol, or herbal products. The severity classification is defined as clinically significant, requiring procedural timing constraints to maintain the therapeutic efficacy of the interacting partner.

Mechanism of Action

How Restime Works: The Mechanism of Action

Restime’s mechanism is based on a non-systemic, physicochemical action confined to the gastrointestinal tract. It does not modulate biological systems such as receptors, enzymes, or neural pathways; the result is an alteration of the gas dynamics within the gut lumen.

Physical Modulation of Gas Surface Tension

The mechanistic basis of the active ingredient, Simethicone, is that of a synthetic surfactant. It achieves a rapid physical action by reducing the surface tension of the foamy liquid that encapsulates the vast number of small gas bubbles trapped in the stomach and intestines. This physical change is the initial and defining step of the mechanism.

Intraluminal Coalescence and Mechanical Enhancement

By disrupting the surface tension, the drug destabilizes the structure of the gas foam, causing the widespread, small bubbles to coalesce rapidly into larger, free pockets of gas. This mechanical change in the gas configuration enhances the potential for gas passage via peristalsis and expulsion. The physical consequence is the modulation of intraluminal pressure exerted on the gastrointestinal wall.

Dosage and Administration Information

How to Use Restime: Official Administration Guidelines

Restime (Simethicone) is administered orally and is available in multiple regulated forms, including oral drops, chewable tablets, and capsules. Its administration follows established standards that define dosing limits and procedural steps for proper use.

Dosage and Frequency

Administration is generally as needed (PRN) for symptoms, typically following meals and at bedtime to address common gas accumulation. The standard adult single dose ranges from 40 mg to 250 mg. The maximum recommended dose for self-medication by adults is 500 mg in any 24-hour period.

Population-Specific Use

Official instructions require dosage adjustments for pediatric patients. Infants (under 2 years) are administered 20 mg per dose, and children (2 to 12 years) receive 40 mg per dose. Due to the medicine's non-systemic action, specific dose adjustments for older adults or those with organ impairment are not typically mandated in official labeling.

Administration Requirements

Procedural instructions are dependent on the specific formulation being used:

  • Chewable tablets must be chewed thoroughly before being swallowed to ensure the release of the active ingredient.
  • Capsules and softgels must be swallowed whole with water.
  • Liquid drops must be measured using the calibrated dropper provided and may be mixed with a small amount of water or infant formula for ease of intake.

The medicine is intended for short-term, episodic use for symptomatic relief, with no mandatory long-term regimens or cyclical dosing patterns specified. The 24-hour maximum dose must not be exceeded during self-medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Restime


Evidence for Use in Managing Sleep Difficulty

Research has studied Restime for outcomes related to difficulty falling asleep or staying asleep. These investigations primarily took the form of controlled clinical trials where participants were evaluated in studies observing responses over defined time intervals, alongside some observational settings evaluating daily-life functioning related to sleep. These studies generally focus on outcomes reflecting daily functioning or activity level and patient-reported outcomes describing perceived discomfort associated with poor sleep.

The research so far indicates that, in the populations studied, studies monitored patterns related to certain outcomes, such as how long it took people to fall asleep or total sleep time. Findings describe patterns observed in the studies where participants reported how symptoms evolved over the short-term study period. These studies help show what has been observed so far regarding how Restime was studied for these common sleep measures.


Evidence for Use in Reducing Daytime Tiredness

Restime was evaluated in studies exploring its relation to outcomes related to feelings of tiredness or lack of energy during the day. These trials research examined outcomes related to systemic or functional imbalance often experienced the day after poor sleep. The study context often involved participants with conditions where symptoms may vary in intensity or those in research scenarios examining temporary physiological imbalance.

The research describes patterns related to how individuals rated their alertness and energy levels in studies observing responses over defined time intervals. Findings indicate that some participants reported how symptoms evolved during the study period, showing changes in their perceived level of daytime fatigue. This research provides insight into short-term changes in outcomes reflecting daily functioning or activity level.


Long-term Studies and Follow-up

Studies exploring Restime over longer periods of time are relevant in evidence describing the durability of any observed changes. The research that is available describes patterns observed in the studies that extended their observation period, but these studies often have sample sizes were modest. Consequently, evidence is limited regarding the very long-term effects of Restime.

The durability of response, meaning how symptoms evolved over time in the observed populations, is not fully established. This highlights a major research limitation: long-term effects are not fully established, and more research is needed to provide context on the continued use of Restime.


Evidence in Specific Groups

Restime was evaluated in various subgroups within the larger clinical trials, but evidence specifically designed for special populations is often less comprehensive. Subgroup findings are uncertain because the study design often did not specifically power these analyses. Data for certain groups remain insufficient. Overall, the research provides context but not individual predictions for these specific groups, and the interpretation of evidence must acknowledge that data for certain groups remain insufficient.


What Is Still Uncertain About Restime

While Restime was evaluated in relation to sleep and tiredness outcomes, several areas of uncertainty and limitation remain in the research landscape. One area of uncertainty is that findings were mixed across some studies, particularly regarding specific outcomes related to systemic or functional imbalance. This means that not every study found the same pattern of results, and certainty remains low for some outcomes related to specific physiological measures. Another key limitation is that comparative evidence is lacking in certain areas. Furthermore, long-term effects are not fully established, and research is ongoing to clarify long-term outcomes and evidence gaps.

Frequently Asked Questions (FAQ)

Common questions about Restime (FAQ)

Q: Does Restime interact with common pain relievers like ibuprofen?

Official drug interaction checks for Simethicone, the active ingredient in Restime, generally show no known interaction with common pain relievers like ibuprofen. This is consistent with Restime's non-systemic nature, which means it acts only in the gut and is not absorbed into the bloodstream.

Q: What happens if I forget to take a dose of Restime?

Since Restime is an Over-The-Counter (OTC) medication used for symptomatic relief of gas as needed, the official labeling does not include instructions for missed doses. Restime is intended to be taken only when gas symptoms are present.

Q: Is Restime the same type of medication as a benzodiazepine?

No. Simethicone (Restime) is classified as an antiflatulent, which works physically in the digestive tract to break up gas bubbles. It is not absorbed into the bloodstream and does not act on the central nervous system (CNS), unlike benzodiazepines.

Q: When is the best time of day to take Restime for its intended effect?

Official directions recommend that Restime be taken when needed for symptoms of gas, typically after meals and at bedtime. This timing is aimed at addressing common periods of gas accumulation.

Q: Can Restime affect my ability to drive or operate machinery the next morning?

According to the official product information, Simethicone (Restime) has little to no influence on the ability to drive or use machines. This is because the medication is not absorbed into the bloodstream and does not have systemic effects.

Q: Are there any known interactions between Restime and herbal supplements like valerian root?

Regulatory documents indicate that there are generally no known restrictions on taking Simethicone with food or most herbal products. This is because the medicine works only in the gut and is not absorbed systemically.

Q: Is it common for Restime to cause dry mouth?

Official adverse event data from some products containing Simethicone report dry mouth as an uncommon side effect. This effect is considered uncommon, meaning it is not frequently reported.

Q: Does Restime cause weight gain or loss?

Official adverse event reports do not list weight gain or loss for Restime. Given that the active ingredient, Simethicone, is not absorbed into the body, it is not expected to cause systemic effects like changes in body weight.

Q: Why do some people experience morning grogginess with Restime?

Simethicone itself is non-systemic and is generally not associated with central nervous system side effects like drowsiness. However, grogginess might occur if the product is a combination medicine or if taken alongside other medications that affect the central nervous system.

Q: Can Restime cause changes in mood or emotional state?

Official drug documents do not list changes in mood or emotional state as reported side effects for Restime. This is consistent with its non-systemic action, meaning it does not affect the brain or the central nervous system.

Q: Does Restime interact with contraceptives or hormone replacement therapies?

Regulatory documents show no known interactions between Simethicone (Restime) and oral contraceptives or common hormone replacement therapies. The only officially documented timing restriction is for thyroid replacement hormones like Levothyroxine.

Q: Can Restime cause a false positive on any drug tests?

Because Simethicone (Restime) is not chemically absorbed into the bloodstream or metabolized by the body, this mechanism suggests a very low likelihood of interference with drug tests that detect systemic substances.

Q: What are the signs that Restime might not be working for me?

Regulatory labeling states that individuals should discontinue use and seek professional advice if symptoms of gas persist, worsen, or if new symptoms develop.

Q: Is there a rebound effect when you stop taking Restime?

Simethicone is not associated with dependency, which makes a pharmacological 'rebound effect' upon cessation highly unlikely. It is not an addictive substance and acts only physically in the gut.

Q: How long does it take to get Restime out of my system if I stop taking it?

Restime is not absorbed into the body. It passes through the gastrointestinal tract and is excreted unchanged, meaning it leaves the body rapidly after its intended physical action is complete.

Q: Has Restime been studied in younger adults or teenagers?

Yes, official dosage directions are provided for adults and children 12 years and over.

Q: Are there any long-term effects of taking Restime consistently?

Due to its lack of systemic absorption, there are no reported systemic long-term effects. The product is intended for short-term, episodic use. Any decision regarding long-term use should be made in consultation with a healthcare professional.

Q: Do I need to take Restime every night for it to be effective?

No. Restime is an Over-The-Counter medication and is administered only as needed for the symptomatic relief of gas and bloating, not as part of a continuous nightly regimen.

Q: Does Restime have a risk of dependence if taken for a long time?

No. Simethicone (Restime) is not a controlled substance, is not absorbed into the bloodstream, and has no established risk of dependence.

How should Restime be stored and disposed of?

The storage and disposal of Restime (Simethicone) must adhere strictly to the conditions specified in official regulatory labeling to maintain product stability and ensure safety.

Official Storage Conditions

Restime must be stored at controlled room temperature, which is between 20°C and 25°C (68°F and 77°F). It is mandatory to protect the medication from moisture and excessive heat, and liquid forms, such as oral drops or suspensions, should not be frozen. The product must remain in its original container, which must be kept tightly closed.

Child Protection and Disposal

For safety, all medication must be stored out of the sight and reach of children, as required by government labeling.

To dispose of unused or expired Restime, patients should prioritize returning it to an authorized drug take-back location. If a take-back program is unavailable, the unused product should be mixed with an unappealing substance, placed in a sealed container, and discarded in the household trash, following official governmental guidelines.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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