Theraflu Kaszel

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Theraflu Kaszel

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 Theraflu Kaszel

Property Description
Active Ingredient Butamirate citrate
Form Oral liquid (syrup, solution, or drops)
Pharmacological Class Non-opioid antitussive agent
Common Purpose Symptomatic relief of dry cough
Origin Synthetic

What Type of Medicine is Theraflu Kaszel? (Classification and Identity)

Theraflu Kaszel is a branded pharmaceutical preparation defined by its active ingredient, the chemically synthesized compound Butamirate citrate. This substance is categorized within pharmacology as a non-opioid antitussive agent, which means its primary function is the suppression of the cough reflex. Butamirate citrate is classified as an antitussive under the Anatomical Therapeutic Chemical (ATC) Code R05DB13, reflecting its role in controlling the coughing mechanism. As a single-component therapy, the medicine is distinct from opioid-related cough suppressants, ensuring the product is non-narcotic.

Composition, Origin, and Available Form

The core composition of this product centers exclusively on Butamirate citrate, which is a fully synthetic molecule designed for central action. Theraflu Kaszel is primarily presented as an oral liquid preparation, commonly a syrup, oral solution, or oral drops. This liquid dosage form is intended for simple oral administration and utilizes an aqueous or syrup-based vehicle to facilitate the systemic absorption of the active compound. The substance functions as a cough center suppressant for acute coughs.

General Therapeutic Purpose of Butamirate Citrate

The fundamental therapeutic purpose of this antitussive is the symptomatic relief of an unproductive cough, universally known as a dry cough. Butamirate citrate achieves this through a mechanism of central cough suppression, where it works to decrease the heightened sensitivity of the cough center located in the brainstem. By diminishing the neurological signal that initiates the reflex, the compound reduces the frequency and intensity of persistent, disruptive coughing spasms that serve no physiological purpose in clearing the airways.

What side effects are possible with Theraflu Kaszel?

Possible Side Effects and Safety Information

Theraflu Kaszel, containing Butamirate citrate, has an officially documented safety profile characterized by a low incidence of adverse reactions, which are classified according to regulatory frequency standards.


Adverse Reaction Scope

The most frequently reported adverse reactions are typically classified as Rare in official product documentation (occurring in geq1/10,000 to <1/1,000 users). These effects primarily involve three System-Organ Classes:

  • Nervous System Disorders: Drowsiness and dizziness.
  • Gastrointestinal Disorders: Nausea and diarrhoea.
  • Skin and Subcutaneous Tissue Disorders: Urticaria (skin rash).

Serious adverse reactions are those related to hypersensitivity, including the risk of severe swelling known as angioedema. While serious, these are generally categorized as Frequency Not Known (cannot be estimated from available data) in regulatory summaries.


Population-Specific Safety Constraints

Official labeling defines key limitations for specific populations:

  • Pregnancy: The medicine is contraindicated during the first trimester of pregnancy due to insufficient safety data. Use during the second and third trimesters requires caution.
  • Pediatrics and Lactation: Use in breastfeeding mothers is not recommended. Furthermore, certain formulations carry a contraindication for use in children under a specific age limit (e.g., below three years).

General Safety Restrictions

Butamirate citrate is contraindicated in individuals with known hypersensitivity to the active substance or its excipients. Additionally, regulatory documents caution that the cough-suppressing action, when combined with expectorants, can lead to the retention of secretions in the respiratory tract, increasing the regulatory risk of airway infections.

Overdose and Emergency Response

Overdose and when to seek help

Overdose from Butamirate citrate, occurring when the administered dose exceeds the recommended limits, is officially documented by regulatory authorities to present with specific clinical manifestations. These signs indicate effects on the central nervous system and the cardiovascular system.

Documented overdose presentations include drowsiness (somnolence) and dizziness, coupled with potentially serious cardiovascular effects such as hypotension (low blood pressure). Gastrointestinal disturbances such as nausea, vomiting, and diarrhea are also recognized presentations listed in official labeling.

Mandated Emergency Action

Regulators explicitly state that if an overdose is suspected, immediate medical advice must be sought, and a doctor or poison center should be contacted right away. This action is critical because official documents confirm that no specific antidote is known for Butamirate citrate.

Management is therefore defined as symptomatic and supportive. Regulatory guidance recommends standard procedures such as gastric lavage and the administration of activated charcoal to manage the overdose. Treatment requires monitoring of vital signs to manage potential physiological compromise, emphasizing the need for professional emergency care.

Therapeutic Uses of Theraflu Kaszel

Theraflu Kaszel, containing the non-opioid antitussive Butamirate citrate, is relevant for easing symptomatic support by addressing distress associated with an irritating cough reflex. It may be part of symptomatic management in clinical contexts where symptoms are disruptive to the patient’s well-being. The primary use is considered to be the symptomatic treatment of non-productive cough.

The medication is commonly applied in addressing the symptomatic relief of the dry, hacking, and unproductive cough, which can intensify into paroxysmal (spasmodic) episodes. It may be part of symptomatic management for conditions characterized by acute symptomatic episodes, such as cough resulting from upper and lower respiratory tract infections including laryngitis and bronchitis. It is also relevant in specialized settings for pre- and post-operative cough sedation. This may assist with symptomatic relief that supports patients during difficult episodes.

“The primary objective is to support the management of the persistent, irritating urge to cough—a symptom that may interfere with daily stability and rest.”


Quick Fact: Relief for Unproductive Cough

Theraflu Kaszel is used for managing the frequency and intensity of the dry, irritating cough, contributing to improved comfort during symptomatic periods and assisting with maintaining functional stability.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Theraflu Kaszel? — Official Regulatory Information


Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed (as stated in label) Adults and adolescents (typically 12 years and over) are permitted under standard labeled conditions.
Populations for whom use is not recommended (if applicable) Use is generally not recommended for children under 6 years of age.
Populations for whom use is contraindicated Patients with hypersensitivity to Butamirate citrate or excipients, including those with hereditary fructose intolerance. Absolute contraindication for children under 3 years of age.
Age-related eligibility rules Use is contraindicated below 3 years. Use in the older adult population is generally defined as “not investigated.”
Pregnancy and lactation eligibility status (if explicitly documented) Contraindicated during the first trimester of pregnancy. Use is not recommended during breastfeeding.
Eligibility-related restrictions Concomitant administration with expectorants or mucolytics must be avoided. Caution is advised for patients with impaired renal or hepatic function.

Resulting Eligibility Structure

Official regulatory documents establish stringent boundaries for Butamirate citrate use, primarily through absolute contraindications based on minimum age, known allergies, and early pregnancy. Eligibility for all other populations is defined by various restrictions and warnings that mandate caution for organ impairment, later stages of pregnancy, and the avoidance of specific co-medications. Regulators classify these rules as Contraindicated, Not Recommended, or requiring Use with Caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Theraflu Kaszel, containing the non-opioid antitussive Butamirate citrate, has documented restrictions and prohibitions regarding co-administration with specific categories of other medicinal products. These official restrictions are classified based on either pharmacodynamic conflict or pharmacokinetic risk, as defined in regulatory documentation.

Prohibited Co-administration

The regulatory profile strictly prohibits the simultaneous use of Theraflu Kaszel with expectorants or other medicines that aid in mucus clearance. This is a mandatory restriction based on a pharmacodynamic interaction where suppressing the cough reflex while increasing the production of bronchial secretions leads to the stagnation of mucus. This accumulation is associated with a risk of secondary complications, which is why the combination is formally classified as contraindicated.

Pharmacokinetic Restrictions

Co-administration is restricted with two key categories of medicinal products due to the potential for altered plasma concentrations:

  1. Strong Enzyme Inhibitors: These substances must be avoided due to the possible risk of an increase in the systemic exposure of Butamirate citrate itself.
  2. Narrow Therapeutic Index Medicines: Co-administration with medicinal products that possess a narrow therapeutic index is restricted. This limitation is due to the possible risk of altered plasma concentrations of the co-administered drug, which carries critical implications for agents with a small safety margin.

No specific timing separation rules or interactions with food, alcohol, or herbal products are documented in the official interaction sections of the prescribing information.

Mechanism of Action

The mechanism of action for Butamirate citrate is characterized by a dual pharmacodynamic influence targeting both the central reflex command and peripheral airway mechanics.

Central Suppression of the Medullary Cough Center

Butamirate citrate achieves its primary action through direct inhibitory modulation of the cough center, a key neuronal network situated in the medulla oblongata of the brainstem. The compound selectively engages and reduces the overall excitability and sensitivity of this center, thereby suppressing the efferent motor signal pathway. This inhibition of the central reflex command results in a reduced output of the motor signals that initiate the respiratory muscular response.

Peripheral Bronchospasmolytic Modulation

Complementary to its central role, Butamirate citrate exerts a secondary, non-central action by influencing the smooth muscle tone of the lower airways. The compound exhibits bronchospasmolytic activity, which promotes the relaxation of the bronchial muscles. This peripheral modulation reduces airway resistance and decreases the afferent signaling input generated by mechanical constriction, acting mechanistically in concert with the central suppression.

Dosage and Administration Information

Theraflu Kaszel, which contains butamirate citrate, is exclusively intended for oral administration as a liquid syrup formulation. The use of this medicine is structured by specific, age-dependent dosing schedules. The prescribed amount must be precisely measured using a graduated scale or measuring cup before intake, and the container should be shaken well prior to each dose. The administration timing is flexible and may occur with or without food.

The standard dosing regimens vary significantly across age groups. Adults typically take a 15 mL dose up to four times daily. Adolescents (over 12 years) and children aged 4 to 12 years follow a schedule of taking the prescribed dose three times per day, with the volume adjusted based on their specific age category.

Age Group Dose per Administration Frequency
Adults 15 mL 4 times daily
Adolescents (12+ years) 15 mL 3 times daily
Children 6–12 years 10 mL 3 times daily
Children 4–6 years 5 mL 3 times daily

This medicine is intended for short-term use, and the treatment course should not exceed four to seven days without professional review. A critical administrative constraint dictates that the syrup must not be used at the same time as expectorants or mucolytics to prevent potential mucus retention in the respiratory tract. No specific dose adjustments are detailed for older adults or individuals with renal or hepatic impairment.

Recent Clinical Evidence

Evidence for Symptomatic Relief of Acute Dry Cough

Research exploring Butamirate citrate examined its use in acute, non-productive cough, which are conditions that involve periods of heightened symptoms. The core evidence comes from short-term Randomized Controlled Trials (RCTs) where researchers monitored patient-reported outcomes describing perceived discomfort, focusing on changes in cough frequency and severity. Studies also included Objective Challenge Studies to measure the cough reflex sensitivity. Findings often describe short-term patterns related to changes in symptoms. However, results from objective measures have been mixed across different research protocols, and long-term effects are not fully established as the evidence primarily focuses on acute episodes of 3 to 7 days.


Comparative Research and Special Populations

Comparative trials evaluated the compound alongside an inactive substance (placebo) and other antitussive agents. These studies explored patterns observed in the research and helped contextualize how symptoms evolved when compared to other medicines. Research has explored Butamirate citrate in adults and the pediatric population. Subgroup studies also included older adults. Evidence highlights that sample sizes were modest in many trials, and data for certain groups remain insufficient, particularly for patients with severe pre-existing functional limitations like renal or hepatic conditions.


Limitations and Research Gaps

The overall evidence quality varies across studies, especially in older trials where methodological standards differ from current requirements. These limitations, combined with the inconsistency between subjective (patient-reported) and objective (laboratory) findings, mean that subgroup findings are uncertain. The research highlights what is known and what is still uncertain regarding the compound, emphasizing that results reflect group patterns and not individual predictions.

Key Studies & References WHO Collaborating Centre for Drug Statistics Methodology: ATC/DDD Index - Butamirate (R05DB13)

Frequently Asked Questions (FAQ)

Common questions about Theraflu Kaszel (FAQ)


Q: Can Theraflu Kaszel be used for a wet or productive cough?

According to the official product information, Theraflu Kaszel is intended for the symptomatic relief of a non-productive, or dry, cough. Regulatory guidance prohibits using this cough suppressant at the same time as expectorants or mucolytics (medicines that help clear mucus). This restriction aims to prevent the stagnation of secretions in the airways, which can lead to complications.


Q: How quickly does Theraflu Kaszel typically start to work?

Official pharmacokinetic data for the syrup formulation suggests a relatively prompt onset of systemic exposure. The peak plasma concentration of the active substance's key metabolite, which provides the cough-suppressing action, is generally reached about 1.5 hours after taking a dose.


Q: How long do the effects of Theraflu Kaszel usually last?

Regulatory data on the compound's elimination profile indicates that the apparent half-life of the active substance in the syrup form is approximately 6 hours. This value describes the time it takes for half of the substance to be eliminated from the body.


Q: Can I take Theraflu Kaszel if I'm taking a prescription medication for high blood pressure?

The official product information includes a general statement of caution regarding co-administration with other medicines classified as having a narrow therapeutic index (a small safety margin). The concern is a possible risk of altered concentrations in the blood for either medicine. Specific interactions for all high blood pressure medications are not detailed in the general regulatory documents.


Q: Is Theraflu Kaszel suitable for people with diabetes?

According to the excipient list, the syrup formulation contains sorbitol, which is a type of sugar alcohol. While this addresses the sugar component, official regulatory labeling carries a specific contraindication for people with rare hereditary problems like fructose intolerance.


Q: What is the difference between Theraflu Kaszel and other common cough syrups?

Theraflu Kaszel is classified by regulators as a non-opioid antitussive agent because its single active ingredient, Butamirate citrate, works by suppressing the central cough reflex. This pharmacological action distinguishes it from other common cough remedies that work peripherally, such as those that thin or loosen mucus.


Q: What are the official warnings about Theraflu Kaszel and liver function?

Official regulatory labeling indicates that clinical data is lacking regarding the use of this medicine in patients with hepatic (liver) impairment. The official labeling contains a statement of caution because individuals with liver function limitations may be at a greater risk of adverse effects due to the accumulation of the drug or its metabolites in the body.


Q: Can I take Theraflu Kaszel if I have a history of kidney problems?

Regulatory labeling indicates that clinical data is currently insufficient for patients with renal (kidney) impairment. A statement of caution is included in the labeling, as there may be an increased risk of adverse effects due to the potential accumulation of the drug and its breakdown products (metabolites) in the body.


Q: Does the formula for Theraflu Kaszel contain sugar?

The syrup formulation contains the excipient sorbitol, which is classified as a sugar alcohol. Due to this component, official regulatory documents state that the medicine is contraindicated for individuals diagnosed with hereditary fructose intolerance.


Q: Is Theraflu Kaszel available over the counter or by prescription only?

Theraflu Kaszel is officially classified as a non-opioid antitussive agent. The regulatory information includes a detailed, patient-facing dosing table for self-administration, which is consistent with the typical presentation of medicines available over-the-counter (OTC) in many jurisdictions.


Q: Are there any herbal supplements or vitamins that interact with Theraflu Kaszel?

Regulatory interaction documents explicitly note that no specific interactions with herbal products or vitamins are documented in the official prescribing information for the product.


Q: Can people with asthma or other breathing issues use Theraflu Kaszel?

Asthma is not listed as an absolute contraindication in official documents. However, regulatory information includes a general caution against using this cough suppressant alongside expectorants (mucus-clearing medicines). This combination can increase the risk of mucus retention, which regulatory documents note may lead to bronchospasm (airway narrowing) or respiratory infections.


Q: Is it okay to drive after taking Theraflu Kaszel?

Official regulatory documents contain a warning that caution is necessary when driving or operating heavy machinery. This precaution is advised because the product may rarely cause side effects such as drowsiness or dizziness in some individuals.


Q: Are there any common reasons why someone might need to stop taking Theraflu Kaszel?

The medicine is intended for short-term use, and regulatory guidance notes the importance of seeking professional review if the cough persists beyond four to seven days. Additionally, the guidance describes discontinuing treatment if rare side effects, such as a rash, nausea, or dizziness, become problematic.


Q: Is Theraflu Kaszel known to cause stomach upset?

The official safety profile for the active ingredient lists gastrointestinal disorders, specifically nausea and diarrhoea, as possible adverse reactions. These effects are typically classified as rare, meaning they occur in a low number of users according to regulatory frequency standards.


Q: Is Theraflu Kaszel considered a non-drowsy formula?

The medicine is pharmacologically classified as a non-opioid antitussive. While official labeling does not use the marketing term 'non-drowsy,' drowsiness is listed as a possible side effect, though it is categorized as rare in official regulatory documents.


Q: Are there studies available about the effectiveness of Theraflu Kaszel?

Official regulatory documentation confirms that the use of this medicine is supported by a research base. The evidence includes short-term Randomized Controlled Trials (RCTs) and Objective Challenge Studies where patient-reported outcomes for cough symptoms were monitored.


Q: Can Theraflu Kaszel be taken with cold and flu remedies from other brands?

The specific restriction listed in the official interaction section is the prohibition of simultaneous use with expectorants or other medicines that help clear mucus. Beyond that, general cautionary statements are included regarding co-administration with strong enzyme inhibitors or medicines with a narrow therapeutic index.


Q: What should I do if I accidentally take more than the recommended amount?

Official regulatory guidance on over-ingestion notes that symptoms may include dizziness, drowsiness, nausea, vomiting, and temporary low blood pressure. In such an event, regulatory guidance describes the use of standard medical treatment, such as activated charcoal administration and monitoring of vital signs.


Q: Is Theraflu Kaszel recommended for elderly patients?

Official regulatory documents indicate that the use of the medicine specifically in the older adult population is defined as “not investigated.” Because of this limited data, no specific dose adjustments or separate recommendations are detailed for this age group in the official product information.


Q: What does the research say about Theraflu Kaszel and cough severity?

Research supporting the use of the active ingredient has included short-term studies that monitored changes in patient-reported outcomes. These studies specifically focused on measuring and reporting patterns observed in both cough frequency and the overall perceived severity of the cough.


Q: Are there different strengths or formulations of Theraflu Kaszel available?

Official regulatory documentation describes Theraflu Kaszel as an oral liquid containing Butamirate citrate, with the dosage varying only by age group. The official product information does not list any other available branded strengths or different dosage forms, such as tablets or capsules.


Q: What kind of professional research supports the use of Theraflu Kaszel?

The evidence supporting the medicine's use is drawn from various professional studies. These include short-term Randomized Controlled Trials (RCTs) to evaluate patient outcomes, as well as Objective Challenge Studies designed to scientifically measure the sensitivity of the cough reflex.


Q: What if I forget to take a dose of Theraflu Kaszel? (non-directive, informational)

Official administrative guidance states that the dose is taken as soon as it is recalled. However, if it is nearly time for the next scheduled dose, the patient is instructed to skip the missed dose and resume the regular schedule. Regulatory information indicates that a double dose should not be taken to compensate for the forgotten one.


Q: Does Theraflu Kaszel have an expiration date, and does it matter?

Regulatory information specifies both the general shelf-life for the product before it is opened and an in-use shelf-life that begins after the bottle is first opened. The product must be safely discarded after this in-use period to ensure product quality and stability.


Q: Does Theraflu Kaszel contain ingredients that can be misused or abused?

The active ingredient in this medicine, Butamirate citrate, is classified as a non-opioid antitussive agent. Official documentation confirms that it is chemically and pharmacologically distinct from opioid-related cough suppressants and does not exhibit the addictive potential typically associated with those ingredients.


Q: What are the official requirements for storing Theraflu Kaszel after opening?

Regulatory requirements mandate that the product must be kept in its original, tightly closed container and stored at a temperature at or below 25 C (77 F). It must not be frozen, and the product must be kept out of the sight and reach of children. The specified in-use shelf-life must be followed after the bottle is opened.


Q: Are there specific drug classes that commonly interact with Theraflu Kaszel?

Regulatory restrictions focus on two primary classes of co-administered medicines. The first is Strong Enzyme Inhibitors, which could increase exposure to Theraflu Kaszel's active ingredient. The second is Narrow Therapeutic Index Medicines, where altered blood concentrations of the co-administered drug carry significant risk.

How should Theraflu Kaszel be stored and disposed of?

How to Store and Dispose of Theraflu Kaszel?

The storage and disposal of this medicine must comply with regulatory requirements to preserve product quality and ensure safety.

Storage Requirements

Theraflu Kaszel (Butamirate citrate oral liquid) must be stored at controlled room temperature, typically below 25°C (77°F), and must not be frozen. It is mandatory to store the product in its original, tightly closed container to protect it from light and moisture. The medicine must be kept out of the sight and reach of children.

Stability and Disposal

The product label specifies an in-use shelf-life after the bottle is first opened, after which the remaining medicine must be safely discarded. Unused or expired product should be disposed of via an authorized drug take-back program. If local programs are unavailable, official guidelines recommend mixing the product with an unappealing substance and placing it in a sealed container before disposal with household trash. Do not dispose of the liquid by pouring it down a sink or toilet.

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

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