Ascoril

Quick links to important sections

Ascoril

Selected form

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Ascoril

Property Description
Active Ingredients Salbutamol, Bromhexine hydrochloride, Guaifenesin
Form Oral liquid (Syrup, Suspension), Tablets
Pharmacological Class Compound preparation (Bronchodilator, Mucolytic, Expectorant)
Common Use Management of symptoms involving constricted airways and excessive mucus
Origin Synthetic Fixed-Dose Combination (FDC)

What Kind of Medicine is Ascoril? (Identity and Classification)

Ascoril is fundamentally a synthetic fixed-dose combination (FDC) medicinal product designed for oral administration, constituting a compound preparation aimed at respiratory symptoms. FDCs, by definition, combine two or more chemically distinct active substances into a single dosage form. Its core identity is that of a multi-action preparation, typically offered as an oral liquid (syrup or suspension) and in tablet form. This FDC strategy ensures that multiple symptomatic pathways are addressed simultaneously, a method widely recognized in clinical practice for managing complex respiratory presentations. The availability of the palatable syrup formulation is often geared toward pediatric patients and others who may have difficulty swallowing solid oral forms.


Composition and Pharmacological Action of the Combination (Composition and Class)

The therapeutic effect of Ascoril is derived from its three active ingredients: Salbutamol, Bromhexine hydrochloride, and Guaifenesin. Each component belongs to a distinct pharmacological class and contributes a complementary action. Salbutamol is categorized as a beta-2 adrenergic agonist, providing the necessary bronchodilator effect. Bromhexine functions as a mucolytic agent, working to decrease mucus viscosity. Guaifenesin is classified as an expectorant, aiding in the effective clearance of sputum from the respiratory tract. This confirms that the combination supports both the opening of the airways and the effective clearance of secretions.


General Purpose and Benefit of the Triple Formulation (General Purpose)

The general purpose of this triple formulation is to provide symptomatic relief from respiratory discomfort, such as in typical scenarios involving a chesty cough accompanied by wheezing or labored breathing. By integrating a bronchodilator with two secretion management agents, the preparation targets the underlying issues simultaneously. This approach supports the body's natural mechanisms for clearing the lower respiratory tract while reducing resistance to airflow, aiming to facilitate less strenuous and more effective breathing.

Regulatory References

  1. Guaifenesin: MedlinePlus Drug Information

What side effects are possible with Ascoril?

Possible Side Effects and Safety Information

The safety profile for this fixed-dose combination primarily reflects the known effects of its active ingredients, with adverse reactions officially classified by frequency and grouped into System Organ Classes (SOCs).


Frequency-Classified Adverse Reactions

The most frequently documented side effects are typically related to the sympathomimetic component. According to regulatory documentation, common adverse reactions are:

Frequency Classification Examples of Adverse Reactions (by SOC)
Very Common Tremor (Nervous System Disorders)
Common Headache (Nervous System Disorders), Tachycardia, Palpitations (Cardiac Disorders), Muscle cramps (Musculoskeletal)
Rare Cardiac arrhythmias, Hypokalaemia (Metabolism and Nutrition Disorders)
Very Rare Hypersensitivity reactions (including collapse), Hyperactivity
Not Known Myocardial ischaemia, Severe skin adverse reactions (e.g., Stevens-Johnson Syndrome)

Serious Adverse Reactions and Safety Constraints

The regulatory profile identifies risks for rare, but clinically significant, serious adverse reactions. These include severe forms of hypersensitivity reactions (e.g., those resulting in collapse) and serious dermatological events, such as Stevens-Johnson Syndrome. The potential for Hypokalaemia (low potassium levels) is documented, which is a known risk with beta-agonist therapy and is a particular consideration in acute severe asthma settings.

Specific safety constraints are noted for certain populations. The medicine is generally not recommended during pregnancy or lactation. Caution is formally advised for patients with pre-existing conditions, including diabetes mellitus, serious cardiovascular disorders, hypertension, and a history of peptic ulcers. Furthermore, the label notes that safety has not been adequately demonstrated for use in children under 2 years of age.

Overdose and Emergency Response

The official regulatory profile for an overdose involving this multi-component product is primarily defined by the severe effects of the beta-agonist, Salbutamol. Documented manifestations include signs of excessive stimulation such as Tachycardia (rapid heart rate), Palpitations, Tremors, and Headache. Gastrointestinal symptoms, including Nausea and Vomiting, are also listed in regulatory texts.

Overdosage is classified as a serious scenario due to the documented potential for critical metabolic and cardiovascular derangements. Severe outcomes listed in regulatory documents include Hypokalaemia (abnormally low potassium levels), Lactic Acidosis, Hyperglycaemia (elevated blood glucose), and serious Cardiac arrhythmias, including myocardial ischaemia.

When Immediate Medical Help is Required

Regulatory authorities strictly mandate that individuals seek immediate medical attention if an overdose is suspected or confirmed. Urgent contact should be made with emergency services or a Poison Control Centre straight away. Management described in official documentation is symptomatic and supportive, focusing on essential clinical monitoring.

Specific monitoring requirements include tracking serum potassium levels and assessing for signs of metabolic acidosis. No specific antidote is officially detailed in the labeling. Population-specific notes indicate that hyperactivity may be a more pronounced symptom in children following excessive exposure.

Therapeutic Uses of Ascoril

What Ascoril Treats: Main Uses and Benefits

Ascoril may be part of symptomatic management across conditions involving inflammatory or irritative processes and associated with increased discomfort. Its application is considered relevant for easing symptoms related to systemic imbalance.

Support for Symptomatic Relief

It is applied across domains where additional symptomatic support is needed, helping to address symptom clusters that may become intense or disruptive. The medication is commonly used across conditions presenting with disruptive episodic manifestations. It helps maintain a sense of stability when symptoms are more noticeable.

Clinical Scenarios and Benefits

This medication is relevant for easing symptoms in situations involving certain distressing symptoms. It helps address symptom clusters that interfere with daily comfort, providing support that helps ease the overall symptom burden in settings marked by temporary physiological imbalance. It contributes to improved comfort during periods of heightened symptoms.


Quick Fact: Supports Symptomatic Relief

  • Quick Fact: Relevant when supportive symptom management is appropriate, particularly for symptoms related to heightened physiological activity.

Eligibility and Restrictions for Use

The official regulatory profile for Ascoril, which contains Salbutamol, Bromhexine, and Guaifenesin, strictly defines eligibility based on age, pre-existing conditions, and physiological status. Eligibility is categorized into contraindications, restricted use, and standard use, as documented in governmental sources.

Absolute Contraindications

Use of the medicine is contraindicated and must not occur in specific populations, including patients with documented hypersensitivity to any component or individuals with severe existing conditions. These include cardiac issues such as tachyarrhythmia or myocarditis, specific heart defects, decompensated diabetes mellitus, thyrotoxicosis, and glaucoma. The medicine is also contraindicated in cases of liver and/or kidney failure, as well as for those with gastric or duodenal ulcers in the exacerbation phase.

Age and Physiological Status

The medicine is strictly contraindicated for use in children under 2 years of age. Use is also prohibited during pregnancy and lactation (breastfeeding). For children aged 2 to 6 years, use is restricted and requires specific guidance from a healthcare professional.

Age Group Regulatory Status
Under 2 Years Contraindicated
2 to 6 Years Restricted Use
6 Years and Older Standard Labeled Use

Conditions Requiring Caution

Regulatory documents mandate that the medicine be used with caution in patients with severe hepatic or renal impairment, as well as those with pre-existing gastric ulceration (non-exacerbation phase) or underlying severe heart disease.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents classify certain combinations with Ascoril (Salbutamol, Bromhexine, Guaifenesin) as restricted or requiring caution due to documented interaction patterns.

Pharmacodynamic Contraindications and Restrictions

Co-administration with non-selective beta-blocking drugs, such as Propranolol, is generally not recommended as these agents oppose the necessary bronchodilatory action of Salbutamol. The product is also restricted for concomitant use with antitussives or medications containing Codeine, as this combination may inhibit the expectorant effect and hinder the clearance of diluted secretions.

Interactions Affecting Risk and Exposure

The combination with Monoamine Oxidase Inhibitors (MAOIs) or Tricyclic Antidepressants is not recommended due to the potential for potentiating the cardiovascular effects of Salbutamol. Diuretics and Corticosteroids augment the risk of hypokalemia when used with the Salbutamol component. Caution is also advised regarding co-administration with halogenated anesthetic agents (e.g., Halothane), due to the documented risk of cardiac effects. Separately, the Bromhexine component promotes the penetration of certain antibiotics (including Erythromycin and Cephalexin) into pulmonary tissue, a form of altered local distribution.

Mechanism of Action

The compound preparation acts through a tripartite mechanism to address two separate, physical components of airflow restriction.

Receptor-Mediated Airway Smooth Muscle Relaxation

This domain is governed by Salbutamol, which functions as an agonist at beta2-adrenergic receptors (beta2-ARs) on the smooth muscle cells lining the bronchial passages. Activation of the beta2-AR pathway initiates an intracellular cascade that ultimately reduces the concentration of calcium ions available for muscle contraction. The resulting physiological effect is the widening of the air passages (bronchodilation), which results in the modulation of lower airway smooth muscle tonus.

Dual Modulation of Secretion Viscosity

This dual mechanism is achieved by Bromhexine and Guaifenesin, which target secretory cells and vagal receptors, respectively. Bromhexine acts to depolymerize certain components of thick mucus and increase the watery component, reducing its viscosity. Simultaneously, Guaifenesin stimulates a reflex that increases the overall volume and hydration of bronchial secretions. These actions collectively facilitate the transport dynamics of the thinned material.

Functional Clearance Synergy

The pharmacological synergy is governed by the complementary relationship between these mechanisms. The muscle relaxation (bronchodilation) widens the airway lumen, creating a larger path for the secretions. The simultaneous thinning and hydrating of the mucus alters the adherence and fluid mobility properties of the material. This coordinated action influences the efficiency of the mucociliary clearance process and the dynamics of secretion expulsion.

Dosage and Administration Information

Official Administration Guidelines

Ascoril is a fixed-dose combination product used according to highly standardized, non-variable instructions. The medication is strictly approved for oral administration in both liquid (syrup or expectorant) and tablet forms, and its use is typically intended for short-term symptomatic courses.

Feature Guideline
Dosing Schedule Adults and Children over 12 years: 10 mL of the syrup or 1 tablet per dose.
Frequency The medicine is prescribed to be taken thrice daily (three times a day), maintaining consistent intervals between doses.
Timing The dose may be administered with or without food.

Procedural Requirements and Population Tiers

The specific administration method is governed by the product format. The liquid form must be shaken well before dispensing each dose to ensure uniform delivery of the active ingredients, and it must be measured precisely using a calibrated device. Tablets, conversely, are to be swallowed whole and must not be crushed, chewed, or broken.

Age-Group Administration: Dosage is tiered based on age groups to standardize use: 5 mL per dose for children 2 to 6 years of age, and 5 to 10 mL per dose for children 6 to 12 years. Older adults are advised to initiate treatment with the lowest dose tier to manage potential sensitivity.

Missed Dose Protocol: Should a dose be missed, protocols advise taking it as soon as remembered; however, if the time is near for the next scheduled dose, the missed dose must be skipped. Patients must be instructed not to double the dose to compensate.

This standardized protocol governs the correct use of the medication, ensuring precise and consistent administration of the bronchodilator and secretolytic components across all treated populations.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ascoril (Triple FDC)

Evidence for Symptomatic Management of Productive Cough

This section summarizes the structure of the clinical research that has explored the fixed-dose combination (FDC) of Salbutamol, Bromhexine, and Guaifenesin. The formulation was evaluated in research exploring how symptoms change over time in contexts where cough is accompanied by excessive mucus and bronchial issues. Research has primarily focused on conditions characterized by fluctuating or episodic manifestations, such as acute bronchitis, acute exacerbations of chronic bronchitis, and related irritative states.

The main body of evidence includes short-term Randomized Controlled Trials (RCTs) that compared the triple FDC formulation against other formulations, such as dual-component FDCs or other common cough preparations. Non-interventional observational studies have also been observed in settings evaluating daily-life functioning when patients use this formulation. Findings describe patterns observed in the studies related to outcomes reflecting daily functioning and patient-reported outcomes over short, defined time intervals.

Types of Clinical Trials and Outcomes Studied

The clinical trials research examined what happens during studies conducted during periods of increased symptom activity. The primary endpoints were monitored to measure changes in the core features of the cough itself, including its frequency and severity. Studies also monitored the characteristics of sputum, measuring its consistency and volume. Further outcomes related to functional status were measured using patient questionnaires or physician assessments to evaluate the overall experience reported during the study period.

The defined observation period in these comparative clinical trials is short-term, with many key randomized studies observing responses over defined time intervals of approximately seven days. The evidence quality is broadly categorized as Moderate-to-Low, a categorization that balances the existence of comparative randomized data and the general limitations often noted in the broader literature concerning complex cough formulations.

Key Studies & References

  1. Annex 5 Guidelines for registration of fixed-dose combination medicinal products (World Health Organization - WHO)

Frequently Asked Questions (FAQ)

Common questions about Ascoril (FAQ)

Q: Does Ascoril help with dry cough or only wet cough?

A: Regulatory documents indicate that Ascoril is formulated to manage productive coughs, which are typically associated with excessive mucus and congestion. It combines a mucolytic and an expectorant to thin and help clear secretions from the airways. Co-administration with cough suppressants is generally not recommended, as this combination may inhibit the clearance of diluted secretions.

Q: How long can I safely use Ascoril for a cough?

A: Official information generally suggests that this type of cough medicine is intended for short-term symptomatic use. Regulatory texts advise against increasing the dosage or frequency if the relief from symptoms begins to diminish. If symptoms persist or worsen, consulting a healthcare professional is recommended for further guidance.

Q: Can people with diabetes safely take Ascoril syrup?

A: Ascoril is contraindicated (should not be used) if the individual has decompensated diabetes mellitus, which is when the condition is not well-controlled. For all other individuals with diabetes, official product information advises caution. This is because the Salbutamol component may affect blood glucose levels, and caution is advised, as blood glucose monitoring is typically a consideration during treatment.

Q: Are there specific warnings for people with thyroid conditions regarding Ascoril?

A: Yes, official regulatory documents state that Ascoril is contraindicated in cases of thyrotoxicosis (a severe form of hyperactive thyroid). Caution is also generally advised for people with hyperthyroidism, due to the potential cardiovascular effects associated with the medication’s components.

Q: What is the typical duration of effect for one dose of Ascoril?

A: The medicine is generally prescribed to be taken three times a day at consistent intervals. This recommended frequency suggests the medicine is intended to provide sustained symptomatic management between doses.

Q: Can Ascoril be taken on an empty stomach?

A: Yes, official administration guidelines state that a dose of Ascoril may be administered either with food or without food.

Q: Are there different types or formulations of Ascoril (e.g., tablet vs. syrup)?

A: Official regulatory documents confirm that Ascoril is available in different forms. These typically include an oral liquid (syrup or expectorant) and a tablet form, confirming the product is available in multiple presentations.

Q: Can Ascoril cause difficulty sleeping or insomnia?

A: While insomnia is not usually listed among the most common side effects, effects related to the nervous system are known. Common effects include tremor and headache, and in very rare cases, hyperactivity. Due to the sympathomimetic component, effects such as headache, tremor, or hyperactivity are possible, which could be associated with sleep disruption.

Q: Why is it recommended to shake the Ascoril syrup bottle before use?

A: It is officially recommended to shake the liquid (syrup or expectorant) form well before dispensing each dose. This step helps ensure that the active ingredients are uniformly distributed throughout the liquid, which is necessary for consistent dosage delivery.

Q: What happens if you take Ascoril more often than recommended?

A: Regulatory warnings strictly advise against increasing the dosage or its frequency of administration if the usual relief is diminished. Doses must also not be doubled to compensate for a missed dose. If the medicine is not providing sufficient relief, consulting a healthcare professional is advised.

Q: Is it okay to drink alcohol while taking Ascoril?

A: Caution is advised regarding the consumption of alcohol. Official safety information notes that this medicine may cause side effects such as drowsiness or dizziness. As alcohol consumption may intensify these central nervous system effects, it could potentially further impair alertness and judgment.

Q: Does Ascoril have an expiration date, and is it still safe after that?

A: Like all medicinal products, Ascoril has a defined expiration date. The medicine should not be used once it has passed this date. Unused or expired medicine must be disposed of safely, in accordance with the specific regulations in the local area.

Q: Does Ascoril have any known interactions with herbal supplements?

A: Official guidance often indicates that there may be insufficient evidence to determine the safety of combining complementary medicines, herbal remedies, and supplements with the active ingredients in Ascoril.

Q: Is Ascoril suitable for elderly patients?

A: For older adults, official administration guidelines recommend initiating treatment using the lowest available dose tier to manage potential sensitivity to the medication. Suitability is generally determined by ensuring the patient does not have any existing contraindications, such as serious heart conditions or severe hypertension.

Q: Why do some people prefer Ascoril over simple cough suppressants?

A: Ascoril is a fixed-dose combination product containing three types of active ingredients: a bronchodilator, a mucolytic, and an expectorant. This multi-action approach is designed to both relax the airways and help clear mucus. In contrast, simple cough suppressants only work by targeting and reducing the cough reflex itself.

How should Ascoril be stored and disposed of?

How to Store and Dispose of Ascoril?

The storage and disposal of Ascoril (syrup/expectorant) must strictly adhere to regulatory labeling requirements to maintain product stability and ensure public safety.


Official Storage Conditions

Requirement Regulatory Mandate
Temperature Store below 30 C and at room temperature (e.g., 20 C to 25 C).
Protection Keep in a clean, dry place, protected from direct sunlight, heat, and moisture.
Container Must be kept in the original container and be tightly closed.
Freezing Do not freeze the syrup formulation.

Child Safety and Disposal

Ascoril must be stored out of the sight and reach of children and pets.

Unused or expired medicine must not be flushed down the toilet or poured into the drain.

Disposal should be handled in accordance with local regulations or by consulting a pharmacist.

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

Available in countries:

Equivalent of Ascoril found in:

A-Z Index: