Ulone

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Ulone

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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 Ulone

Property Description
Active ingredient Clofedanol (Chlophedianol hydrochloride)
Form Oral Syrup, Tablets, Capsules
Pharmacological class Centrally Acting Antitussive
Common use Symptomatic relief of dry, non-productive cough
Origin Synthetic Organic Compound

What Type of Medicine is Ulone?

Ulone is a pharmaceutical product defined by its active substance, Clofedanol (Chlophedianol hydrochloride), and is classified as an antitussive agent. This designation places it in the specific category of medications whose primary function is to suppress the cough reflex.

The drug is a synthetic organic compound and belongs to the non-opioid class of cough suppressants, which is clinically recognized for providing relief without the addictive potential associated with narcotic cough medicines. Clofedanol is characterized as being centrally acting, meaning its suppressive effect occurs directly at the cough center in the brainstem. As a non-opioid antitussive, Clofedanol inhibits the cough reflex through this central action. This indicates that the medicine provides relief by reducing the nerve signals that prompt the urge to cough.

Composition and Physical Forms

The composition of Ulone is focused on the single active substance, Clofedanol hydrochloride. While its core identity is rooted in this single-ingredient product, it is a key component in certain formulations regulated for use in various countries. This single-agent focus makes it distinct in scenarios where only the antitussive action is required.

As an orally administered product, Ulone is made available to patients in multiple common dosage forms, including a liquid syrup format which utilizes an aqueous base, and solid preparations such as tablets or capsules. These forms ensure consistent delivery of the antitussive agent.

General Purpose and Primary Benefit

The therapeutic purpose of Ulone is the symptomatic relief of cough, particularly targeting those coughs that are non-productive and irritating—for instance, a persistent, dry cough that interferes with sleep. The medicine's effect is fundamentally to interrupt the unnecessary cough reflex cycle, rather than addressing any underlying condition or facilitating the clearing of the respiratory tract.

By dampening the central neurological trigger for coughing, Clofedanol reduces the intensity and frequency of persistent, dry fits. This action translates into the practical benefit of reducing the physical fatigue and discomfort caused by continuous coughing, thereby promoting necessary periods of rest.

What side effects are possible with Ulone?

Possible Side Effects and Safety Information

The safety profile of Ulone (Clofedanol) is primarily defined by its action on the central nervous system (CNS), as classified in official regulatory documents. Adverse reactions are grouped by System-Organ Class and frequency to communicate potential risks.


Adverse Reaction Classification

Classification Examples of Officially Documented Effects
Common (More Frequent) Drowsiness, dizziness, nausea, dry mouth.
Rare Hallucinations, skin rash (hives).

Adverse reactions involving the Nervous System (drowsiness, dizziness, excitation) and Gastrointestinal Disorders (nausea, vomiting) are commonly documented. Effects such as blurred vision and increased heart rate (tachycardia) are also noted.

Serious Safety Notes and Restrictions

Regulatory labeling highlights specific safety limitations. A core restriction is the contraindication of Ulone for use in patients who are currently taking or have recently taken a Monoamine Oxidase Inhibitor (MAOI) within the last 14 days, due to the risk of severe adverse effects. Furthermore, official safety information specifies that the drug may increase the effect of drowsiness when used concurrently with alcohol or other CNS depressants.

Population-Specific Safety Considerations

Safety data addresses specific populations. Older adults may be more susceptible to CNS-related side effects such as confusion. For the pediatric population, excitability and hyperirritability have been noted as potential adverse reactions. Additionally, many adverse effects, including drowsiness and visual disturbance, are explicitly documented as occurring with larger doses.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation outlines the overdose profile of Clofedanol based on specific, documented central nervous system (CNS) manifestations. Overexposure may lead to significant neurological changes. The reported manifestations include marked drowsiness, reflecting a substantial depressant effect on the CNS. Conversely, a paradoxical CNS effect, excitability, is also documented as a potential presentation in overdose situations. Furthermore, exposure to high doses is associated with the potential for signs related to anticholinergic effects.

Mandated Emergency Action

Regulatory bodies mandate an immediate emergency response in all instances of suspected overdose or ingestion that exceeds the labeled therapeutic amount. The required and necessary action is to get medical help or contact a Poison Control Center right away. This explicit instruction applies universally, regardless of the initial presence or absence of severe symptoms, as professional medical assessment is required to manage documented effects.

Population-Specific Consideration

The official labeling includes a specific population note: excitability may occur, especially in children. This emphasizes the unique risk profile in the pediatric population, where the response to overexposure may involve pronounced agitation rather than only sedation. The primary step for management remains the immediate fulfillment of the regulatory requirement to notify emergency services or Poison Control for guidance and supportive care.

Therapeutic Uses of Ulone

What Ulone Treats: Main Uses and Benefits

Ulone is applied in contexts where temporary symptomatic relief from an irritating, non-productive cough is needed. The active ingredient, Clofedanol, is applied across domains where additional symptomatic support is needed, consistent with its classification as an antitussive agent. This therapeutic domain covers coughs often associated with conditions involving inflammatory or irritative processes, like those from the common cold or influenza, and is also relevant when supportive symptom management is appropriate for short-term airway irritation. The medicine helps address symptom clusters that may appear suddenly and become difficult to tolerate.

The core benefit is reducing the urge and frequency of the cough, which contributes to easing the overall symptom load. This is relevant when symptoms interfere with daily comfort, particularly when the cough is dry and persistent. “The medication provides support that helps ease the overall symptom burden during difficult symptomatic episodes.” By assisting with maintaining functional stability, Ulone supports patients during episodes of heightened discomfort and helps contribute to improved comfort.

Quick Fact: Relief for Disruptive Dry Cough Ulone is commonly used across conditions characterized by periods of heightened symptoms to help manage cough-induced interference with rest.

Eligibility and Restrictions for Use

Who Can and Cannot Use Ulone?

The official regulatory documents for Ulone (Clofedanol) define specific boundaries for use based on age, concurrent medication, and pre-existing health status.


Absolute Non-Eligibility and Contraindications

Ulone must not be used by the following groups, as strictly stated in the regulatory labeling:

  • Infants and Toddlers: Children younger than two years of age are strictly non-eligible.
  • Concurrent Medication: Patients currently receiving, or who have stopped within the last 14 days, a Monoamine Oxidase Inhibitor (MAOI).
  • Cough Profile: Patients with a cough that produces excessive phlegm or mucus (productive cough), or a chronic cough associated with conditions like asthma or emphysema.

Conditional Use and Professional Consultation

Use of Ulone is conditional and requires consultation with a doctor or pharmacist for individuals who fall into the following categories:

  • Pediatric Use: Children two to under six years of age.
  • Organ Function: Individuals with liver or kidney disease.
  • Special Populations: Individuals who are pregnant or breastfeeding.
  • Pre-existing Conditions: Patients with glaucoma, difficulty urinating (e.g., due to an enlarged prostate), heart disease, high blood pressure, thyroid disease, or diabetes.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Ulone's official regulatory interaction profile is governed by its central activity as an antitussive and is structured around a formal prohibition and pharmacodynamic additive effects with other substances. The profile focuses on substances that impact the Central Nervous System (CNS) or those that affect monoamine oxidase.

Official Contraindication and Restrictions

Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is formally contraindicated due to the potential for severe adverse reactions. The regulatory documents require a mandatory separation period: at least 14 days must pass after discontinuing an MAOI before Ulone administration may be initiated.

Documented Pharmacodynamic Interactions

The co-administration of Ulone with other CNS Depressants, including Sedatives and Tranquilizers, results in additive depressant effects. This pharmacodynamic interaction may increase the intensity of drowsiness.

Interaction with Other Products

Regulatory labels indicate that the use of Ulone concurrently with Alcohol should be avoided because alcohol can increase the sedative effect. Furthermore, combining Ulone with CNS Stimulants may lead to additive effects, increasing the risk of excitability. Official labeling does not document clinically significant pharmacokinetic interactions requiring dose adjustment based on CYP enzyme activity or transporter effects.

Mechanism of Action

How Ulone Works

Clofedanol (Ulone) operates through multifaceted mechanisms, with a primary central action complemented by an accessory peripheral action.


Modulating the Central Cough Reflex Threshold

This domain covers the drug's primary mechanism: the central depression of the Medullary Cough Center in the brainstem. By potentially modulating inhibitory GABAergic pathways, the drug decreases the neuronal excitability of CNS neurons within this center. This mechanistic cascade elevates the stimulation threshold required to activate the cough reflex, leading to the physiological consequence of a higher stimulation threshold for reflex initiation.


Auxiliary Peripheral Sensory Attenuation

This mechanism interacts with the central effect by targeting peripheral signaling. Clofedanol exerts mild local anesthetic blockade on sensory nerve endings in the respiratory mucosa and acts as an H1 receptor antagonist. This action helps limit the transmission of irritant signals from the airways to the CNS. This domain modulates peripheral signaling by reducing the afferent sensory input that feeds into the central cough reflex arc.

Dosage and Administration Information

Ulone is administered through the oral route and is available in pharmaceutical preparations such as syrup, tablets, and capsules. The usage pattern is structured for temporary, as-needed relief, with all administration details strictly defined by regulatory standards.


Administration Guideline Official Specification
Standard Adult Dose A single dose of 25 mg of Clofedanol.
Dosing Frequency Every 6 to 8 hours, administered as needed for symptoms.
Maximum Daily Limit Not to exceed 100 mg (four doses) in a 24-hour period.
Duration Constraint Use must be discontinued if symptoms persist for more than 7 days.
Intake Condition Can be taken with or without food.

Administration Rules and Procedural Constraints

For the liquid syrup formulation, accurate measurement is required using a calibrated dosing device, rather than a common household spoon, to ensure the correct amount is administered. Intake is permitted irrespective of meal timing.

Usage protocols define specific administration rules for different age groups. Adults and children 12 years of age and older follow the 25 mg regimen. A reduced dose of 12.5 mg is specified for children 6 to under 12 years of age. Administration to children under 6 years of age is generally not recommended under the standard guidelines.

This structured approach ensures that the medicine is administered within established dosing and duration boundaries as mandated by governmental regulatory agencies.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ulone (Clofedanol)

Research on Ulone (Clofedanol) has explored the active ingredient in studies examining short-term symptomatic patterns. The evidence base consists primarily of Randomized Controlled Trials (RCTs) and controlled laboratory studies that have examined the agent's performance relative to an inactive substance (placebo) and other similar agents. This overview describes what the existing research explored, and what remains uncertain about the evidence.


Evidence for Symptomatic Relief of Dry Cough

The clinical context studied was non-productive (dry) cough often associated with acute or disruptive episodes. These trials typically researched the use of the agent in patients experiencing conditions characterized by fluctuating or episodic manifestations of cough. Researchers primarily monitored two main outcomes related to physical discomfort: the objective cough frequency and patient-reported outcomes describing perceived discomfort.

When Ulone was evaluated in these settings, the findings describe patterns observed in the studies related to measured outcomes. The active ingredient was reviewed based on data and historical usage patterns, contributing to the broader evidence landscape.

Long-Term Data and Duration of Effect

The majority of studies relevant in trials assessing short-term or episodic symptom patterns for Ulone explored the immediate, acute changes related to the agent. The research typically monitored changes in outcomes related to physical discomfort over short, defined time intervals, such as up to 24 hours. Because the clinical trials were studied for short-term symptom changes for acute coughs, long-term effects are not fully established. The available data are still emerging regarding the measured changes in cough symptoms for coughs that persist for weeks.


What Research Gaps and Uncertainties Remain

One key limitation is that sample sizes were modest in many older trials. The evidence quality varies across studies, leading to some heterogeneity in the findings observed. Evidence for use in older adults with multiple comorbidities is not well-characterized, and specific information for other patient groups remains limited. It is important to remember that study results describe group patterns, not personal outcomes. The evidence highlights what is known—and what is still uncertain—about the active ingredient.

Key Studies & References

  1. Chlophedianol - StatPearls - NCBI

Frequently Asked Questions (FAQ)

Common questions about Ulone (FAQ)


Q: How quickly can a person expect to notice any effects from Ulone?

A: Studies and official information indicate that Ulone, a centrally acting cough suppressant, is generally described as having a rapid onset of action. This indicates the effects are typically observed relatively soon after administration. The active ingredient usually reaches its highest concentrations in the body within a few hours after it is taken.


Q: How long does Ulone stay in your system after you stop taking it?

A: The duration Ulone remains in the body is related to its elimination half-life, which is documented in official data on how the drug moves through the body. The active substance is typically eliminated from the body within a relatively short period after the last dose, though this can vary based on individual factors.


Q: Is there a risk of dependence or withdrawal associated with Ulone, according to regulators?

A: Ulone’s active ingredient, Clofedanol, is classified as a non-opioid antitussive. Regulatory bodies typically do not classify it as a controlled substance, and official labels do not generally list dependence or withdrawal as primary risks for this non-opioid medicine.


Q: Is Ulone the same as the generic version, and is the generic version as effective?

A: Ulone’s active ingredient is Clofedanol. Regulatory agencies require generic versions containing the same active ingredient to be proven therapeutically equivalent to the brand-name product. This means the generic form is designed to provide comparable clinical effects and safety information when compared to the brand-name product.


Q: Is Ulone considered a controlled substance by regulatory bodies?

A: Ulone's active ingredient is generally not classified as a controlled substance under the U.S. Controlled Substances Act (CSA) or similar international frameworks. However, regulations concerning over-the-counter medications may vary, and some regions may apply restrictions on how it is sold or dispensed.


Q: What should be done if a dose of Ulone is accidentally missed?

A: Official patient instructions generally describe the procedure for a missed dose, which often involves taking the forgotten dose when remembered, unless the next dose is due shortly. Always refer to the package information for specific timing guidance. Regulatory documents state that a double dose is not to be used to compensate for a single missed dose.


Q: Are there any gender-specific differences in how Ulone works or its side effects?

A: Official regulatory labels and major clinical studies for Ulone do not generally specify major differences based on gender. Adverse event reporting data for centrally acting medicines may occasionally describe minor variances in how frequently certain side effects are reported between men and women.


Q: Is Ulone considered a first-line treatment for the condition it treats?

A: Ulone is classified as an accessible, over-the-counter (OTC) antitussive agent intended for the temporary symptomatic relief of dry cough. Its primary role, as defined in regulatory documents, is the temporary relief of symptoms.


Q: Is it normal to feel [minor, common side effect like mild nausea] when starting Ulone?

A: According to official product information, nausea is listed as a common adverse reaction to Ulone. Common side effects are those observed most frequently during clinical evaluation. Since nausea is classified as a common adverse reaction, its occurrence is frequently noted when a person begins using the medication.


Q: Does taking Ulone affect my ability to drive or operate machinery?

A: Yes, official safety warnings advise that Ulone may cause marked drowsiness or dizziness. Official warnings describe that caution is required when driving a motor vehicle or operating machinery until the user knows how the product affects their alertness.


Q: Can Ulone cause a change in weight, based on official information?

A: A change in weight is not generally listed among the common or rare adverse reactions that are documented in official regulatory labeling for the active ingredient, Clofedanol.


Q: Does Ulone interact with common supplements like St. John's Wort or vitamins?

A: Official drug labels focus primarily on warnings about prescription medications like MAOIs and other CNS depressants. However, the concurrent use of Ulone with any non-prescription product, herbal supplement, or vitamin is listed as a scenario requiring professional review to ensure safety.


Q: Is Ulone safe for use in older adults (geriatric patients)?

A: Official safety data indicates that older adults may be more susceptible to CNS-related side effects, such as drowsiness and confusion, when using Ulone. Official labeling places use in this population into a category of conditional use, due to the potential for increased CNS-related side effects.


Q: Can women who are pregnant or planning to become pregnant use Ulone?

A: Official regulatory labeling places pregnancy and planning a pregnancy in a category of conditional use. The product information states that the potential benefits and risks of using the drug during these times must be considered, as its use is conditional.


Q: Is there information about Ulone use while breastfeeding?

A: Official documents list breastfeeding as a category for conditional use. The product information states that the potential benefits and risks of using the drug while breastfeeding must be considered, as its use is conditional.


Q: Can Ulone affect my sleep patterns, like causing insomnia or making me drowsy?

A: Yes, official labeling lists both drowsiness (a common effect) and sleeplessness (insomnia) (sometimes associated with excitability) as potential adverse effects. These documented effects confirm that the medicine can influence normal sleep patterns.


Q: Is there a maximum time frame for how long a person is typically on Ulone?

A: The official product monograph specifies a duration constraint for use. The medication is required to be discontinued if cough symptoms persist for more than 7 days. The drug is intended only for short-term, temporary relief of acute symptoms.


Q: What if I take my other medications at the same time as Ulone?

A: Official labeling states that Ulone can be taken with or without food. While the medication can be taken alongside many other drugs, co-administration with other CNS depressants is strongly warned against due to the risk of additive sedative effects. Official labeling provides guidance on timing and potential additive effects with other CNS depressants, and reviewing this information is necessary before use.


Q: Does taking Ulone require any regular blood tests or monitoring?

A: Official regulatory documents do not generally require routine laboratory tests or special monitoring, such as regular blood tests, for Ulone use.


Q: Is it a common concern that Ulone can cause allergic reactions?

A: Official labeling lists skin rash (hives) as a rare adverse reaction. However, regulatory warnings instruct all users to seek help immediately if they experience signs of a serious allergic reaction, such as swelling, severe dizziness, or trouble breathing, which is a standard precaution for any medication.


Q: What information is available about discontinuing Ulone under a doctor's supervision?

A: Ulone is designed for temporary, as-needed relief. The primary official constraint regarding the duration of use is the condition for discontinuation if cough symptoms persist for more than 7 days. The drug is described as being for temporary, symptom-based use.


Q: How long after taking Ulone is it typically absorbed by the body?

A: Regulatory data on how the drug moves through the body describes that the time required for Ulone to be absorbed and reach its peak concentration in the bloodstream is within a short time frame. This period is typically less than two hours after the oral dose is taken.


Q: Is Ulone available as a liquid or other form besides a pill?

A: Yes, official documents confirm that Ulone is available in multiple dosage forms for oral administration. These preparations include a liquid syrup, as well as solid forms like tablets and capsules.


Q: What is the full list of inactive ingredients in Ulone tablets?

A: The official product labeling, such as the information found on DailyMed, is required to disclose the full list of inactive ingredients for each specific formulation. These substances, which are not medically active, typically include elements like coloring agents, flavoring agents, stabilizers, and fillers.


Q: What is the reduced dose specified for children 6 to under 12 years of age?

A: The official administration guidelines for the active ingredient specify a reduced single dose for children in this age group. This detail is found within the regulatory directions for use, which also outline the appropriate frequency and maximum duration of administration.

How should Ulone be stored and disposed of?

How to Store and Dispose of Ulone

The storage and disposal of Ulone (Clofedanol) must strictly follow official regulatory guidelines to maintain its quality and prevent environmental risk.

Storage Requirements

Ulone must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). The product must be kept from freezing and protected from excess moisture and light. It is mandatory to keep the medicine in its original container, tightly closed, and stored out of the sight and reach of children.

Disposal Instructions

Do not dispose of unused or expired Ulone by flushing it down a toilet or pouring it down a drain. Disposal in household trash is also prohibited. To comply with environmental and safety regulations, all unused medication must be discarded through an approved drug take-back program or other pharmaceutical waste collection methods.

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

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