Infacolic

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Medically reviewed

Rosario Oropesa

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 Infacolic

Property Description
Active ingredient Simeticone (INN)
Form Oral Liquid Drops (Suspension/Emulsion)
Pharmacological class Antiflatulent / Gastrointestinal Agent
Common use Relief of gas-related bloating and flatulence
Origin Synthetic, silicon-based polymer

What Type of Medicine is Infacolic and What is its Core Purpose?

Infacolic is a specific brand of pharmaceutical preparation classified as an Antiflatulent, a targeted member of the Miscellaneous Gastrointestinal Agents drug class. It is predominantly marketed as an Over-the-Counter (OTC) medicine. The core purpose of this medicine is the physical relief of discomfort, pressure, and sensations of bloating and flatulence resulting from excessive gas trapped in the digestive system. The active ingredient, Simeticone (INN), defines it as a monotherapy product, focusing solely on this antifoaming action. Simethicone is recognized as effective for the relief of gas and its associated symptoms, operating as a physical agent rather than a systemic drug.


Simeticone: Understanding the Active Ingredient and Composition

The active component, Simeticone, is a synthetic, silicon-based polymer, chemically described as a mixture of polydimethylsiloxanes and silicon dioxide. This chemical composition enables the compound to function as a surface-active agent exclusively within the gastrointestinal tract. Crucially, Simeticone is non-systemically absorbed; it acts locally and is excreted unchanged in the feces. This localized action contributes to the compound's safety margin when used for gas relief.


The Oral Liquid Drops Formulation and its Function

Infacolic is supplied as an oral liquid drops formulation, typically an aqueous suspension or emulsion. This specific format—oral drops—is a key feature, as it is designed for precise, small-volume dosing, often targeting the pediatric patient group. This liquid form ensures the Simeticone is immediately and widely dispersed throughout the gut contents upon ingestion. This rapid dispersion is necessary for the compound's antifoaming action, which reduces the surface tension of small gas bubbles, causing them to coalesce into larger, more easily passed gas pockets, directly supporting the product’s function of pressure relief.

Regulatory References

  1. NIH StatPearls Simethicone Monograph

What side effects are possible with Infacolic?

Possible Side Effects and Safety Information

The safety profile of Infacolic, which contains the active ingredient Simeticone, is based on the agent's unique mechanism: it is not systemically absorbed into the bloodstream but acts locally within the gastrointestinal tract and is excreted unchanged. This non-systemic action is the foundation for its low potential for systemic adverse effects, leading to an official classification as a very safe medicine.


Documented Adverse Reactions

Official regulatory documents emphasize that Simeticone is generally not known to cause any side effects in the majority of users. Consequently, common or uncommon adverse reactions are not typically listed in regulatory labeling.

Adverse reactions are classified within the following System-Organ Classes:

  • Gastrointestinal Disorders: Mild, temporary events such as diarrhea or nausea have been reported but are infrequent.
  • Immune System and Skin Disorders: The most significant safety consideration is the possibility of a hypersensitivity reaction.

Serious Adverse Reactions and Restrictions

The most clinically significant, though rare, documented risk is a severe allergic reaction (anaphylaxis). Symptoms may include a severe, sudden rash, hives, or swelling of the face, lips, tongue, or throat, alongside difficulty breathing.

Use is strictly constrained by a known hypersensitivity to Simeticone or any of the inactive ingredients in the product.

Population-Specific Safety Notes

The lack of systemic absorption is the key factor structuring the safety profile across populations. Official sources confirm that this non-absorbed nature means that the medicine's safety profile is considered well-established for use in infants and children. It is also deemed acceptable for use during pregnancy and breastfeeding.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Simeticone (Infacolic) overdose is defined by the compound's fundamental property of lacking systemic absorption. Because the active ingredient is an inert substance that acts locally and is excreted unchanged, severe or life-threatening systemic outcomes are not anticipated or documented in official regulatory sources.


Documented Manifestations and Emergency Action

Element Official Regulatory Statement
Documented Manifestations The only officially noted possible manifestation is constipation, a theoretical, localized gastrointestinal effect [NIH MedlinePlus].
Severe Outcomes None are officially documented; systemic effects like kidney injury or cardiovascular issues are not expected [FDA DailyMed].
Emergency Action Mandate Immediate medical attention is critical even if no symptoms are noticed. Contact a Poison Control Center or seek emergency medical help right away [FDA DailyMed].

Overdose Management

Official management protocols confirm that no specific antidote is known or required. The necessary intervention involves discontinuing the medication and providing supportive measures. For the theoretical manifestation of constipation, some regulatory documents advise treating with fluids and keeping the patient under observation [UK MHRA SmPC]. Regulatory requirements emphasize that all suspected overdose scenarios require prompt medical consultation.

Therapeutic Uses of Infacolic

What Infacolic Treats: Main Uses and Benefits

Relieving Abdominal Pain and Distress in Infant Colic

The medication is commonly used in situations involving certain distressing symptoms associated with infant colic and gripe, specifically when symptoms are driven by trapped gas, and provides support that helps ease the overall symptom load. This agent is relevant in contexts marked by increased discomfort and tension in infants. It helps address symptom clusters that may become intense or disruptive, such as episodes of inconsolable crying, abdominal pain, and restlessness that cluster into patterns requiring supportive management. It contributes to improved comfort during periods of heightened symptoms, which may assist with maintaining functional stability.


Managing Flatulence, Bloating, and Gastrointestinal Pressure

The primary therapeutic domains may include assistance in managing episodes marked by abdominal distension, flatulence, and griping pains. The medication is generally considered relevant in conditions involving episodic or fluctuating manifestations of gastrointestinal gas retention in situations where patients experience these symptoms. It helps address symptom groups like the feeling of fullness and tightness that create noticeable physiological strain. It is applied when symptoms interfere with daily functioning, contributing to easing the overall symptom load.


Quick Fact: Symptomatic Relief for Gas-Related Discomfort
This medicine is primarily used for the symptomatic management of colic-related gas and general abdominal pressure in infants, children, and adults.

Regulatory References

  1. NIH StatPearls overview on Simethicone

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Infacolic

Official regulatory documents define the eligibility for Infacolic (Simeticone) primarily based on specific contraindications and approved age groups.

Category Official Regulatory Statement
Populations for whom use is allowed Permitted for use in newborns (from birth onwards), infants, children, and adults.
Populations for whom use is contraindicated Patients with known or suspected hypersensitivity to Simeticone or to the listed excipients, such as Methyl and Propyl Hydroxybenzoates.
Condition-specific eligibility rules Contraindicated in patients who are currently being treated for a thyroid disorder, particularly when taking Levothyroxine.
Pregnancy and lactation eligibility Permitted during pregnancy and breastfeeding due to the lack of systemic absorption.

Official eligibility statements:

  • The medicine is approved for use in all age groups, starting from birth onwards.
  • Use is contraindicated if the patient is being treated for a thyroid disorder, as Infacolic may reduce the absorption of that medication.
  • The official labeling permits use for pregnant and breastfeeding persons because the active ingredient is not absorbed into the bloodstream.

This eligibility structure establishes broad permissibility while strictly mandating exclusions only for hypersensitivity and concurrent thyroid treatment, reflecting the compound's localized action.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Infacolic (Simeticone) is highly limited due to its physical mechanism of action. Because the active ingredient is not absorbed into the bloodstream, it has a minimal potential for systemic drug-drug interactions (DDIs) involving liver enzymes or drug transporters. This non-systemic nature means formal metabolic and transporter-based interactions are not documented in official regulatory labeling.

Interaction Scope Official Regulatory Statement
Medicines with documented interactions: Levothyroxine (and related thyroid hormone products).
Mechanistic basis: Local gastrointestinal interference with the absorption of the co-administered medicine.
Timing-based interaction rules: Mandatory separation of administration is required when taken with Levothyroxine.

The most significant official finding is the local interaction with Levothyroxine. Regulatory documents consistently state that co-administration may reduce the systemic exposure of this thyroid medication by physically hindering its absorption in the gut. To manage this potential for reduced exposure and ensure therapeutic stability, an administration timing separation is required, meaning the two products must be taken several hours apart as defined by specific regulatory guidance. No combinations are formally classified as contraindicated, and no interactions are explicitly documented with food, alcohol, or herbal products in major governmental labels. This interaction structure establishes one primary constraint within the product’s official regulatory profile and confirms a generally low risk for systemic interaction.

Mechanism of Action

How Infacolic Works

Infacolic's mechanism of action is defined by a physico-chemical process that is strictly localized to the gastrointestinal (GI) lumen; it does not engage classical biological targets such as receptors, enzymes, or transporters. The active component, Simeticone, operates as a surface-active agent by interacting directly with the liquid-gas interface of small, trapped gas bubbles in the gut contents.

Mechanistic Cascade: Gas Coalescence

Simeticone initiates a reduction in surface tension within the liquid film surrounding these small gas bubbles. This physical alteration destabilizes the bubbles, causing them to break and coalesce (merge) into fewer, larger gas pockets. This cascade transforms the gas architecture from a highly dispersed, foam-like state to a free, continuous state.

Physiological Consequence

Following coalescence, the resulting large gas pockets exhibit increased mobility and are acted upon by normal peristalsis (the gut's muscle contractions). This change in gas dynamics supports the evacuation of the gas through eructation or flatus, which results in a corresponding adjustment of mechanical pressure within the intestinal wall.

Dosage and Administration Information

Instruction Map: How to use Infacolic — Administration Guidelines

This map outlines the instructions for the use of Infacolic (Simeticone oral drops), focusing on administrative procedures and dosing constraints.


Administration Scope

Feature Instruction
Route of administration Oral administration of the liquid suspension/emulsion.
Dosing schedule The dose is age-specific: Infants (Under 2 years) receive 20 mg (0.3 mL) per dose, and Children (2 years and older) receive 40 mg (0.6 mL) per dose.
Timing in relation to meals (if applicable) The medication is to be administered after meals and at bedtime.
Preparation requirements (if applicable) The liquid formulation must be shaken well before the dose is measured for administration.
Age-group administration rules Dosing amounts are explicitly differentiated by age/weight and must not exceed 12 administrations per 24-hour period.
Missed-dose rules This medication is generally intended for intermittent use (as needed) based on the presence of symptoms, and therefore has no fixed schedule for missed doses.
Special procedural conditions The measured dose must be drawn using the calibrated dropper or syringe provided and may be mixed with 1 oz (30 mL) of water, formula, or other suitable liquids.

Instruction Classifications (High-Level)

Classification Pattern
Administration method type Oral
Frequency pattern As-needed (Intermittent)
Use-context constraints Usage is limited by a maximum daily frequency and requires a specific, controlled delivery mechanism.

Resulting Procedural Structure

Step sequence:

  • Shake the liquid suspension thoroughly.
  • Measure the precise, age-appropriate volume using the calibrated dropper only.
  • Administer the dose orally, typically after meals and at bedtime.

Connection to the overall use protocol (2–4 sentences): These instructions establish a structured use protocol emphasizing precision and dose control for this agent. The guidance mandates the use of specific measuring equipment and outlines the total allowable frequency, thereby standardizing how the medication is delivered to the target population. The designated timing ensures adherence to the usage constraints for intake.

Recent Clinical Evidence

Research evidence / Overview of Studies for Infacolic


Evidence for Use in Gas-Related Distress in Infant Colic

The research for Simeticone's use in infants primarily consists of short-term Randomized Controlled Trials (RCTs) and major systematic reviews that have explored how symptoms change over time. These studies were applied in research contexts involving conditions associated with acute or disruptive episodes, focusing on babies who met clinical criteria for colic. Researchers examined outcomes related to physical discomfort and daily functioning, with a focus on measuring changes in the daily duration of inconsolable crying and the frequency of crying episodes over defined time intervals.

When compared to an inactive placebo, some trials reported that outcomes were not significantly different, which suggests that certainty remains low regarding consistency of findings describe patterns observed on outcomes related to physical discomfort in colicky infants. The research base is characterized by sample sizes were modest in many of the core studies, and a limitation identified in peer-reviewed scientific literature is the inconsistency of the findings across different trials.


Evidence for General Gastrointestinal Gas Retention

The use of Simeticone was evaluated in conditions associated with acute or disruptive episodes such as flatulence, bloating, and abdominal discomfort, in several types of trials, including Randomized Controlled Trials (RCTs) and therapeutic reviews. Studies examined patient-reported outcomes describing perceived discomfort, such as severity scores for bloating and the feeling of fullness in the abdomen. Research highlights findings describe patterns observed in the studies, reporting that some trials monitored outcomes related to systemic or functional imbalance.

It was observed in some studies that findings regarding the medicine when used alone (monotherapy) were sometimes mixed or contradictory, as much of the data comes from trials where the medicine was assessed as part of a combination-therapy. The overall evidence quality varies across studies; for instance, comparative evidence is lacking regarding performance against an inactive treatment for the infant colic indication.

Key Studies & References

  1. Simethicone - StatPearls (Review of indications, flatulence/bloating, and colic research)
  2. Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended Simeticone Disflatyl UK/W/0084/pdWS/001 (Regulatory assessment of paediatric data)

Frequently Asked Questions (FAQ)

Common questions about Infacolic (FAQ)

Q: How quickly should Infacolic start working for typical use?

A: Official product information describes that the anticipated improvements from use are often gradual and may develop over several days of continued administration, due to the medicine’s physical mechanism of action.

Q: How long does the effect of Infacolic typically last?

A: Infacolic is generally intended for 'as-needed' or intermittent use, which means it is administered based on the presence of symptoms rather than a fixed schedule. The frequency of use is therefore guided by the patient’s discomfort and the return of symptoms, not a set duration of relief.

Q: How long can a person continue to use Infacolic?

A: Regulatory guidance generally describes the use of the medicine as being symptom-guided, and administration is typically discontinued when symptoms improve. If symptoms persist or worsen, consulting a healthcare professional is usually recommended.

Q: Are there foods or drinks that should be avoided while using Infacolic?

A: Official regulatory labeling for Infacolic does not document any known interactions with food, alcohol, or common herbal products that would require their avoidance. However, administration instructions usually specify that the dose is given after meals.

Q: What is the difference between Infacolic and a generic version?

A: Official regulatory standards require that generic products are equivalent in terms of active ingredient, Simeticone, strength, and delivery route, making them therapeutically comparable. Any differences are typically limited to inactive ingredients or the brand name.

Q: What kind of scientific research is available on Infacolic? [Combined intent of questions on research results and consensus]

A: The scientific literature relies on randomized controlled trials and major reviews. However, authoritative reviews note that findings from these studies are often reported as inconsistent or mixed when compared to an inactive placebo. Because of this, the official reviews conclude that the certainty of the evidence remains low.

Q: Is Infacolic a common prescription for its intended use?

A: Infacolic is classified and predominantly marketed as an Over-the-Counter (OTC) medicine. This means it is generally available for purchase without requiring a prescription from a healthcare provider.

Q: What Infacolic is used for, besides the primary approved use?

A: In addition to its primary purpose of relieving gas and bloating, Simeticone, the active ingredient, is officially recognized for other uses. It is used as an antifoaming agent to improve visualization during certain diagnostic medical procedures, such as endoscopy or radiography.

Q: Is Infacolic considered a natural medicine?

A: No. The active ingredient in Infacolic, Simeticone, is chemically described in official documents as a synthetic, silicon-based polymer. Its composition means it is classified as a pharmaceutical agent, not a natural medicine.

Q: Can Infacolic be taken with milk or food?

A: Official administration instructions state that the medicine is typically given after meals and at bedtime. When preparing the dose, the measured liquid may be mixed with water, formula, or other suitable liquids before it is administered.

Q: Does Infacolic have different versions or strengths?

A: The active ingredient, Simeticone, is authorized for use in multiple product strengths and dosage forms, such as drops, tablets, or capsules, across different brands for various patient groups. The Infacolic brand itself uses different volumes of the same concentration to achieve its age-appropriate doses.

Q: Are there common reasons why Infacolic might not seem to work for someone?

A: Official clinical research notes that outcomes are not consistent across all individuals who use the medicine, reflecting the mixed or contradictory evidence. This is a recognized limitation of the studies on the product.

Q: Is it common to feel drowsy after taking Infacolic?

A: Official regulatory documents do not typically report systemic adverse effects such as drowsiness. This is because the active ingredient is not absorbed into the bloodstream but acts locally within the digestive tract.

Q: Can Infacolic be used by older adults?

A: Official regulatory documents permit the use of Infacolic across the entire adult population. The medicine’s non-systemic action means that no specific dosage adjustments or special warnings are documented for older adults.

Q: What if a dose of Infacolic is missed—what are the general instructions?

A: Since Infacolic is intended for intermittent use, or only as needed for symptoms, there is no fixed schedule for missed doses. Administration should simply be resumed with the next required dose when symptoms are present again.

Q: Can Infacolic cause stomach upset?

A: While the medicine is generally well-tolerated, official regulatory documents note that mild and temporary gastrointestinal disorders have been infrequently reported. These may include events such as diarrhea or nausea.

Q: Is Infacolic suitable for individuals with kidney conditions?

A: The active ingredient, Simeticone, is not absorbed into the bloodstream or processed metabolically. Due to this non-systemic action, official labeling does not document special warnings or dosage adjustments related to kidney function.

Q: Does Infacolic show up on standard drug tests?

A: Because the active ingredient in Infacolic is not systemically absorbed into the bloodstream and is instead excreted unchanged, it is not expected to be detected on standard drug screening tests designed for systemic drugs.

Q: Are there specific patient groups where Infacolic is not recommended?

A: Official regulatory documents define two primary groups for whom use is contraindicated. This includes patients with a known hypersensitivity to the ingredients, or patients who are currently being treated for a thyroid disorder, due to the risk of a documented interaction.

Q: Does Infacolic affect blood pressure or heart rate?

A: Official regulatory documents do not list changes to blood pressure or heart rate as expected or common adverse effects. This is because the active ingredient is not absorbed into the bloodstream and therefore does not affect the cardiovascular system.

Q: Is Infacolic habit-forming or addictive?

A: No. The active ingredient is not absorbed into the body and does not act on the central nervous system. Official regulatory guidance therefore confirms there are no concerns for dependency, habit formation, or addiction with its use.

Q: Is it necessary to finish the entire course of Infacolic, even if symptoms improve?

A: No fixed course of treatment is established for this medicine. Since Infacolic is intended for intermittent use, administration is based on the presence of symptoms and is generally discontinued when those symptoms resolve.

Q: Is Infacolic appropriate for people who are sensitive to medicine?

A: The active ingredient's non-systemic action, meaning it is not absorbed into the body, is the foundation for its very low potential for systemic adverse effects. This specific mechanism is a key factor cited in the product's regulatory safety profile.

Q: Does Infacolic interact with herbal supplements?

A: Official regulatory labeling does not document any known interactions between Infacolic and herbal supplements. The product’s non-systemic action generally minimizes the potential for systemic drug interactions.

Q: Is Infacolic linked to changes in mood or sleep?

A: Official regulatory documents do not list changes in mood or sleep as common or expected side effects. This is due to the fact that the active ingredient is not absorbed into the bloodstream and is not known to act on the central nervous system.

Q: Is Infacolic known to cause dry mouth?

A: Dry mouth is not documented as a common or uncommon adverse reaction in the official regulatory documents for Infacolic. Side effects are primarily confined to the gastrointestinal tract or rare allergic reactions.

Q: What are the characteristics of the patient population included in Infacolic's key studies?

A: The primary patient groups studied and cited in authoritative regulatory reviews have included infants who met the clinical criteria for colic, as well as patients across age groups experiencing general gas retention, bloating, and discomfort.

Q: Does Infacolic affect other laboratory test results?

A: Regulatory documents warn that the medicine may interfere with a specific type of laboratory test. It can potentially cause a false-negative result for occult blood in the stool in what is known as the gastric guaiac test.

Q: Are there special warnings about driving or operating machinery while using Infacolic?

A: Official regulatory documents do not include specific warnings regarding the ability to drive or operate machinery. This is because the active ingredient is not systemically absorbed and is not associated with central nervous system effects like drowsiness or dizziness.

How should Infacolic be stored and disposed of?

Official Storage and Disposal Requirements

This information is strictly based on official government regulatory documents, such as those published by European and national health agencies.

Storage Component Requirement
Maximum Temperature Do not store above 25 C.
Child Safety Keep out of the reach and sight of children.
In-Use Stability Use within 28 days after first opening.
Shelf-Life Do not use after the expiry date (EXP) stated on the carton.
Disposal Rule Do not dispose of the medicine via wastewater or household waste.

Official disposal rules require consulting a pharmacist for instructions on how to discard unused or expired medicine. This procedure helps to protect the environment and aligns with mandatory regulatory guidelines.

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

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