Infacol

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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 Infacol

Property Description
Active ingredient Simeticone (Simethicone)
Form Oral Suspension (Drops)
Pharmacological class Antiflatulent, Antifoaming Agent
Common use Relief of trapped wind and gas discomfort
Origin Synthetic (Silicone-based)

What is Infacol and What Type of Medicine is It?

Infacol is an Over-the-Counter (OTC) pharmaceutical product specifically marketed and formulated as an oral suspension (liquid drops). It is classified pharmacologically as an antiflatulent and antifoaming agent. Its primary purpose is to provide effective relief from the discomfort and pressure caused by trapped wind and excess gas, often associated with infant colic. The active ingredient, Simeticone, is clinically recognized for its ability to modify gas properties within the gut. This medicine is distinctively positioned for paediatric use, being suitable from birth, and commonly features a citrus or orange flavor to enhance palatability.

Infacol's Composition: Simeticone and Its Origin

The sole active ingredient in Infacol is Simeticone (also known as Simethicone), a single, chemically inert compound derived from silicone (a synthetic polymer known as Polydimethylsiloxane). This synthetic substance is non-systemic; it is not absorbed into the bloodstream. Simeticone is well-tolerated and acts locally within the gastrointestinal tract to provide relief. The liquid dosage form, delivered via a calibrated dropper, ensures easy and precise administration for its target infant audience.

How Infacol's Action Relieves Trapped Wind

Infacol achieves relief through a physical mechanism known as antifoaming action. Simeticone functions as a surfactant that significantly reduces the surface tension of the tiny, numerous gas bubbles often suspended in the gut mucus. This action causes the small bubbles to rapidly merge, or coalesce, into larger, more mobile pockets of free gas. This physical change facilitates the easy expulsion of the gas from the digestive tract—either through burping or passing flatus—which directly alleviates the painful pressure and bloating associated with the trapped wind.

What side effects are possible with Infacol?

Possible Side Effects and Safety Information

The safety profile of Infacol, which contains the active ingredient Simeticone, is primarily shaped by its non-systemic action. Simeticone is a chemically inert substance that is not absorbed into the bloodstream, limiting potential systemic effects on major organs.

Officially Documented Adverse Reactions

Adverse reactions documented in official regulatory sources are centered on allergic reactions (hypersensitivity) reported from post-marketing experience. These are officially classified under Immune System Disorders and Skin and Subcutaneous Tissue Disorders.

Classification Adverse Reactions
Skin and Subcutaneous Tissue Rash, Pruritus (itching)
Serious Reactions Angioedema (swelling beneath the skin)

The frequency of these hypersensitivity reactions is officially classified as Not Known. This classification is used when the available data, typically from spontaneous post-marketing reports, is insufficient to reliably estimate the rate of occurrence.

Safety Constraints and Special Populations

Simeticone-containing products are contraindicated and should not be used in individuals with known or suspected intestinal perforation or intestinal obstruction. This limitation is documented in official labeling to avoid compounding complications related to compromised gastrointestinal integrity.

Due to the lack of systemic absorption, regulatory documents do not typically list specific safety considerations or dose adjustments for patient populations with impaired renal or hepatic function.

Overdose and Emergency Response

Overdose and when to seek help

The primary active ingredient in Infacol is simethicone, an antiflatulent agent. Due to the nature of this substance, it is generally considered not absorbed into the bloodstream or body tissues. This characteristic means that significant systemic toxicity or severe adverse clinical effects from an overdose are typically not expected.

Because the drug is not absorbed, regulatory documents often indicate that there is generally no treatment for a simethicone overdose other than stopping the medication and monitoring the individual. The focus of official instructions is on ensuring general safety rather than managing a severe toxic state.

When to Seek Urgent Medical Help

Official regulatory guidelines for simethicone products specify that immediate action is required in any case of suspected overdose. Regardless of the low systemic risk, the following instruction must be followed:

  • In case of overdose, get medical help or contact a Poison Control Center right away.

This guidance is mandatory for the safe handling of medication and to ensure the well-being of the patient, particularly in the pediatric population. As with all medicines, Infacol must be kept out of reach of children.

Therapeutic Uses of Infacol

What Infacol Treats: Main Uses and Benefits

Infacol is generally used to provide direct symptomatic support for gastrointestinal distress and physical discomfort related to the accumulation of trapped gas. It is relevant for easing symptoms related to abdominal distension, fullness, and painful internal pressure. Simeticone is commonly used to help with symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This supportive relief contributes to easing the overall symptom load for the infant during episodes of heightened discomfort.


Symptomatic Support and Clinical Contexts

This medication is commonly applied in the paediatric domain to help with the distressing symptoms associated with infant colic and griping pain, particularly when these conditions are driven by gas accumulation. It is relevant for managing behavioral manifestations like inconsolable crying and the infant drawing their legs up in distress—symptoms that interfere with daily functioning. It is commonly used to help with primary indications including trapped wind, bloating, excessive gas, and infant colic driven by gas pressure.

“This symptomatic relief helps patients cope more steadily with difficult episodes by reducing physical pressure.”

The therapeutic application is generally relevant for newborns and infants in situations where they experience recurrent digestive distress around feeding. When applied when appropriate for this purpose, it contributes to improved comfort, assists with maintaining functional stability, and supports a more settled state following feeding.


Quick Fact

Quick Fact: Relief for Gas-Driven Discomfort

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Eligibility to Use Infacol

Infacol, which contains the active ingredient simeticone, is a medicine suitable for use in infants, babies, and newborns from birth onwards.

Populations Who Must Not Use Infacol (Contraindications)

The medicine is formally contraindicated and must not be used by infants with a known hypersensitivity (allergy) to the active substance, simeticone, or to any of the other excipients (inactive ingredients) in the oral suspension.

Groups Requiring Special Consideration

Infants currently being treated for a thyroid disorder (such as congenital hypothyroidism) must not be given Infacol without first consulting a doctor. This is an important restriction because simeticone can interfere with the absorption of the thyroid medication, levothyroxine, potentially reducing its effectiveness.

Furthermore, the formulation contains certain preservatives (methyl and propyl hydroxybenzoates) which are associated with a risk of allergic reactions, which may be delayed.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Infacol (simeticone) has a highly limited interaction profile because its active component is not absorbed into the bloodstream and acts locally within the digestive system. Therefore, it does not typically participate in metabolic enzyme (CYP) or drug transporter interactions.

The only established, officially documented drug-drug interaction involves medications containing levothyroxine.


Documented Drug Interaction

Interacting Medicine Interaction Mechanism & Effect Official Regulatory Note
Levothyroxine (Thyroid Hormone Replacement) Simeticone may bind to levothyroxine in the gut, which can reduce the amount of levothyroxine absorbed into the body, potentially leading to reduced effectiveness. If the baby is being treated for a thyroid disorder, medical consultation is required.

Other Interaction Contexts

Interaction Type Regulatory Status
Contraindicated Combinations None formally documented.
Food, Alcohol, or Herbal Products No clinically significant interactions are documented in official regulatory labeling.
Timing Requirements No formal mandatory spacing rules are documented; however, the risk of reduced absorption of levothyroxine suggests that timing adjustments may be necessary under medical guidance.

This limited interaction structure reflects the local, non-systemic activity of simeticone as described in authoritative regulatory sources.

Mechanism of Action

The mechanism of action for Infacol, which contains simeticone, is purely physical and localized to the gastrointestinal (GI) tract lumen; it does not rely on systemic absorption or interaction with cellular biological targets like receptors or enzymes. The drug's inert physical property defines its action.

Physical Modulation of Gastrointestinal Fluid Dynamics

Simeticone functions as a surfactant that targets the liquid-gas interface of the numerous small gas bubbles trapped within the gut contents (chyme and mucus). The drug’s mechanism centers on lowering the surface tension of the films surrounding these microbubbles, an action that destabilizes the foam-like gas structure.

Mechanistic Cascade: Gas Consolidation and Elimination

The reduction in surface tension drives a rapid mechanistic cascade known as antifoaming action, causing the formerly trapped, microscopic bubbles to quickly coalesce into fewer, larger pockets of free gas. This physiological consequence is significant because the reformed large gas pockets can then be more easily transported and physically expelled from the body via natural means, which supports the reduction of intraluminal distension.

Dosage and Administration Information

How to Use Infacol

This section outlines the instructions for the administration of Infacol oral suspension. This information defines the standardized method of usage.


Administration Scope

Feature Guideline
Route of Administration The medicine is strictly for oral administration.
Standard Dose and Frequency The standard starting dose is 20 mg (0.5 mL), which must be administered before each feed.
Dose Adjustment If symptoms do not improve after three to four days of standard use, the dose may be increased to 40 mg (1.0 mL) per administration.
Age Suitability The product is suitable for use in infants from birth onwards.
Course Duration The treatment must be continued for several days to observe the full, progressive effect, and may be used for several weeks if needed.

Procedural Administration Requirements

The following steps are required to ensure accurate and proper administration:

  1. The bottle must be gently shaken immediately prior to drawing up the dose.
  2. The correct dose must be measured using the calibrated dropper provided with the product.
  3. The suspension should be administered directly onto the back of the infant’s tongue before the feed commences.
  4. If a dose is missed, the protocol is to simply give the next scheduled dose before the baby's next feed; compensation for the missed amount is not required.

This protocol involves continuous use linked to the infant’s feeding cycle to maintain the intended usage pattern.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Infacol

Evidence for Use in Infant Colic

Research was studied for Simeticone, the active ingredient in Infacol, focusing on its use in infants meeting criteria for colic. These investigations primarily used short-term Randomized Controlled Trials (RCTs) and systematic reviews. Researchers monitored outcomes that reflect daily functioning or activity level, such as total daily crying time and parental reporting of symptom change.

The evidence base for this specific use is noted for its inconsistency. While some individual trials described patterns where symptoms evolved in the observed populations, many large-scale systematic analyses reported that findings were mixed. The data show patterns related to limited certainty, as many studies found no significant difference between the outcomes in the Simeticone group and the placebo group.

Evidence for General Gas Symptoms and Bloating

Beyond infant colic, Simeticone was evaluated in trials exploring its role in managing general symptoms of gas accumulation, fullness, and abdominal pressure. These studies was observed in populations including adults with gas-related functional symptoms, as well as older children. Research examined outcomes related to physical discomfort (bloating and pressure) by tracking subjective symptom scores applied in studies examining patient-reported experiences.

Role of Simeticone in Diagnostic Procedures

A distinct body of research was studied for Simeticone's use in studies designed to manage foam, which is relevant in preparation for medical procedures. This research explores Simeticone's study design as an agent for improved visualization during diagnostic endoscopy (gastroscopy or colonoscopy). Research describes that the presence of gas bubbles was observed in some studies to be reduced when the agent was administered, providing context on the agent's behavior in a clinical setting.

Research Gaps and Areas of Uncertainty

The scientific consensus acknowledges that evidence quality varies across studies and follow-up durations that were limited, often reporting results over only one or two weeks. Because of this short observation window, long-term effects are not fully established. Certainty remains low in the infant colic research due to trial design and modest sample sizes. The available research provides context on how symptoms were measured, but research does not determine whether an individual will respond similarly to the group patterns reported.

Key Studies & References

  1. Simethicone Use and Common Indications: NIH MedlinePlus Summary
  2. Effect of simethicone on crying time in infants with colic: a meta-analysis of randomized controlled trials

Frequently Asked Questions (FAQ)

Common questions about Infacol (FAQ)

Q: Does Infacol interact with infant vitamins or supplements?

Simeticone is not absorbed into the bloodstream, and official documents note that it has a highly limited interaction profile. While no clinically significant interactions are documented for food or herbal products, official guidance emphasizes reviewing the product label and discussing any concerns with a healthcare professional.

Q: Can Infacol be used at the same time as pain relievers like paracetamol?

Simeticone is a locally acting medicine whose non-systemic nature minimizes the potential for drug interactions. Because of this, its interaction profile is highly limited. Official instructions emphasize reviewing the product label and consulting a healthcare professional when administering Infacol alongside any other medication.

Q: Can Infacol be mixed into a bottle of milk?

Regulatory labeling for some simeticone suspensions notes that the dosage may be mixed with infant formula, cool water, or other suitable liquids. This method is described on some regulatory labels as an alternative to the standard procedure of applying the drops directly onto the baby's tongue before a feed.

Q: Does Infacol expire, and where is the expiration date?

Official product labels specify the shelf life for the sealed bottle, and the expiration date is typically printed on the container. Regulatory documents also define the time frame within which the medicine must be used after the bottle is opened, usually 28 days.

Q: What should I do if the symptoms do not improve after using Infacol?

Official guidance states that if symptoms persist or worsen, or if the product has been used regularly for more than a defined period, seeking medical advice is appropriate. This step allows a healthcare professional to review the baby's condition and determine whether treatment should be adjusted.

Q: Does Infacol contain any artificial colors, preservatives, sugar, or alcohol?

The official product information lists all excipients, or non-active ingredients, including flavorings and thickening agents. Preservatives, such as methyl and propyl hydroxybenzoates, are present in the formulation. Depending on the specific product, it may contain sugar substitutes like maltitol, and some formulations are confirmed as 'dye free' (without artificial colors).

Q: Does Infacol change the composition of breast milk or formula?

Infacol's active ingredient, simeticone, is not absorbed into the bloodstream, meaning its action is local and non-systemic. Due to this negligible systemic exposure, official information suggests that no effect on the composition of breast milk or formula is anticipated.

Q: How quickly should I expect Infacol to start working?

Official guidance indicates that the antifoaming action of simeticone may begin to work within approximately 30 minutes after administration. However, for continuous conditions like colic, it may require regular administration over several days to observe the full, progressive effect.

Q: Can Infacol affect a baby's bowel movements or cause constipation?

While Infacol has a limited side effect profile, official documents have occasionally reported mild gastrointestinal symptoms as undesirable effects. These have included slight changes in bowel movements, such as constipation or loose stool/mild diarrhea.

Q: Is it possible to give a baby too much Infacol?

Simeticone is generally considered non-toxic because it is not absorbed into the system. However, official instructions state that in the event of an overdose, it is necessary to contact a poison control center or seek medical assistance.

Q: Can a baby become dependent on Infacol?

The active ingredient, simeticone, is chemically inert, and its action is purely physical and localized to the gut. Due to this non-systemic mechanism, official information suggests that simeticone is not known to cause physical or pharmacological dependence.

Q: What information should I read before starting Infacol?

Official guidance emphasizes the necessity of reading the full product label and the package leaflet entirely before administering the medicine. This documentation provides all the official instructions, safety warnings, and proper usage requirements.

Q: Can I stop using Infacol suddenly?

As simeticone acts locally and is not associated with pharmacological dependence, there is no formally documented need for tapering the dose when stopping use. The medicine is primarily intended for symptomatic relief.

Q: Does Infacol prevent colic from starting?

The product's official indication, as stated in regulatory documents, is for the symptomatic relief of trapped wind and infant colic. Regulatory documents do not typically support a claim that the medicine prevents colic from starting.

Q: Is Infacol suitable for babies with lactose intolerance?

The active ingredient, simeticone, does not contain lactose. However, suitability for babies with specific conditions like lactose intolerance depends on all the excipients (non-active ingredients) used in the specific product's formulation. It is necessary to review these excipients against the product label.

How should Infacol be stored and disposed of?

How to Store and Dispose of Infacol?

Regulatory documents define specific conditions for storing Infacol (Simeticone oral suspension) to ensure product integrity and child safety.


Storage and Stability Requirements

Classification Requirement
Maximum Temperature Do not store above 25°C (77°F).
In-Use Stability Must be used within 28 days after opening the bottle.
Safety Mandate Keep the medicine out of the sight and reach of children.

Official Disposal Instructions

To discard expired or unused product, do not dispose of Infacol via wastewater or regular household waste. The official instruction is to ask a pharmacist for guidance on proper disposal according to local pharmaceutical waste regulations.

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

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