Колдрекс

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Колдрекс

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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 Колдрекс

Quick Facts

Property Description
Active ingredients Acetaminophen, Caffeine, Phenylephrine, Ascorbic acid, Terpinhydrate
Form Tablets and powder for oral solution (hot drink)
Pharmacological class Analgesic-antipyretic combination with decongestant and expectorant properties
Common use Symptomatic relief of common cold and flu
Origin Synthetic and semi-synthetic compounds

What Kind of Medicine is Колдрекс?

Колдрекс is an over-the-counter (OTC) medicinal entity classified as a combined preparation intended for the symptomatic treatment of acute viral upper respiratory tract infections, such as the common cold and flu. This systemic, synthetic drug entity is designed to provide comprehensive relief, distinguishing it from single-active ingredient remedies by targeting multiple symptoms simultaneously. Its pharmacological class is defined by its core actions: analgesic-antipyretic combined with decongestant, expectorant, and psychostimulant properties.

The use of multiple active ingredients is intended for the efficient treatment of cold and flu symptoms collectively. This specific type of multi-ingredient formulation is a common strategy for managing the complex symptoms of the common cold, addressing the cluster of fever, pain, and congestion with a singular product.

Composition and Forms: Is Колдрекс a Single-Ingredient Drug?

Колдрекс is a combination product, integrating five distinct active ingredients: Acetaminophen (Paracetamol), Phenylephrine Hydrochloride, Caffeine, Terpinhydrate, and Ascorbic acid (supplied as Sodium Ascorbate). These components are delivered through two primary dosage form(s): solid tablets and a granulated powder for oral solution (hot drink mix), both intended for the oral route of administration.

The unique five-part composition ensures a broad spectrum of relief. Acetaminophen provides the foundational pain and fever relief, while Phenylephrine offers targeted relief of nasal congestion. Phenylephrine acts as a vasoconstrictor to reduce mucosal swelling in the nose, which serves as a mechanism for relieving nasal congestion. This complexity allows Колдрекс to address the full profile of cold discomfort, from systemic malaise to specific respiratory symptoms.

General Purpose: What Does Колдрекс Help Relieve?

The overall general purpose of the Колдрекс preparation is to achieve rapid, symptomatic relief during the acute phase of a cold or flu, often used when symptoms like headache, muscle soreness, and a blocked nose interfere with daily activity. The combined mechanism of effect is formulated to mitigate both general systemic symptoms and localized respiratory distress.

Specifically, the drug is formulated to help reduce fever (pyrexia) and alleviate generalized pain syndrome via its antipyretic and analgesic effects. Simultaneously, it addresses respiratory discomfort by reducing nasal congestion and supporting the clearance of mucus from the airways. The medicine’s function is strictly centered on managing the discomfort of these symptoms, rather than engaging in the process of treating the underlying viral infection.

Regulatory References

  1. NIH/NCBI on multi-ingredient cold relief
  2. Official UK MHRA Coldrex Product Details

What side effects are possible with Колдрекс?

Possible Side Effects and Safety Information

The safety profile for this multi-ingredient cold and flu medicine is based on official regulatory documentation, which categorizes adverse reactions by frequency and physiological system involved.

Adverse Reaction Scope

Classification Tier Officially Documented Effects (Examples)
Common Headache, nausea, vomiting, dizziness, restlessness, difficulty sleeping, and stomach pain.
Rare / Very Rare Unusually fast heart rate (tachycardia), raised blood pressure (hypertension), unexplained bruising or bleeding, and certain visual disturbances. Very rare reactions include serious skin conditions.

System-Organ Class Involvement

Side effects are noted across several systems in official labeling. These include Nervous System Disorders (e.g., insomnia, dizziness), Gastrointestinal Disorders (e.g., nausea, heartburn), Cardiac Disorders (e.g., arrhythmia, raised blood pressure), and Immune System Disorders (e.g., hypersensitivity reactions).

Serious Adverse Reactions and Key Constraints

The most significant safety feature explicitly documented in official regulatory labeling is the risk of Severe Liver Damage/Failure, primarily associated with the Acetaminophen component, especially if the maximum recommended dose is exceeded. Signs of this damage may have a delayed onset of 12 to 48 hours after ingestion. Severe allergic reactions, such as Anaphylactic Shock and Serious Skin Reactions, are also documented.

Safety restrictions mandate that the product must not be taken concurrently with any other product containing Acetaminophen or in individuals with certain pre-existing conditions, including severe liver or kidney problems, or high blood pressure. Safety guidance also notes that patients who experience dizziness or drowsiness should not operate machinery.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory information emphasizes that prompt medical attention is critical following an overdose, even if the person feels well. Immediate medical advice must be sought and the patient should be urgently referred to a hospital or Poison Control Center.

Overdose manifestations are structured around the primary active components and their potential for delayed and acute toxicity:

  • Delayed Toxicity (Acetaminophen): Initial symptoms may be non-specific, including Nausea, Vomiting, Abdominal pain, and Sweating. The critical concern is the delayed onset of Severe liver damage (Hepatotoxicity), which may progress to Hepatic failure and can be fatal. Jaundice and upper stomach pain may appear later.

  • Acute Toxicity (Phenylephrine and Caffeine): Immediate severe symptoms may include CNS stimulation (e.g., Excitement, Hallucinations, Seizures), Cardiovascular effects (e.g., Hypertension, Tachycardia, Cardiac arrhythmias), and muscle twitching. The regulatory profile notes that overdose may be fatal, particularly in children.

Overdose management requires the administration of the specific antidote, N-acetylcysteine, preferably within 8 to 10 hours post-ingestion, and the close monitoring of hepatic and renal function. The hazard of overdose is greater in individuals with pre-existing underlying liver disease or those who are malnourished.

Therapeutic Uses of Колдрекс

What Колдрекс Treats: Main Uses and Benefits

The medication is generally considered relevant for symptomatic management across therapeutic domains involving acute or disruptive symptom patterns associated with the common cold and influenza. This category of multi-ingredient preparation is characterized as being commonly used when short-term symptomatic assistance is needed.

Easing Systemic Discomfort and Pain Syndrome

This component is applied across domains where additional symptomatic support is needed to address symptoms related to systemic imbalance, specifically fever and generalized physical discomfort. It is relevant for easing challenging symptoms like headache, sore throat, and widespread muscle and joint pain, providing support that helps ease the overall symptom burden.

Managing Nasal and Airway Symptom Discomfort

The formulation helps address symptom clusters that may become intense or disruptive in the upper respiratory tract. It is applied in situations where nasal congestion and sinus pressure interfere with daily comfort, assisting with maintaining functional stability related to breathing. Furthermore, its expectorant component also supports the loosening of thickened mucus, which may assist with managing the symptom load of a wet cough.

“The primary goal is to address simultaneous symptoms, supporting patients during episodes of heightened discomfort.”

Quick Fact: Symptomatic Support for Multiple Manifestations The product is commonly used for managing simultaneous manifestations including fever, headache, sore throat, and nasal congestion during the acute phase of illness.

Regulatory References

  1. Health Canada Non-prescription Oral Adult Cough, Cold and Flu Labelling Standard

Eligibility and Restrictions for Use

Who Can and Cannot Use Coldrex (Колдрекс) - Official Regulatory Information

Coldrex, a combination product, has defined eligibility rules based on regulatory guidelines, primarily determined by the presence of Acetaminophen, Phenylephrine, and Caffeine. Eligibility is generally restricted to adults and adolescents 12 years of age and over who do not have contraindicating conditions.

Absolute Contraindications (Must Not Use)

Use is prohibited for patients with specific, high-risk conditions as stated in official labeling:

  • Severe Hepatic or Severe Renal Impairment.
  • Uncontrolled or Severe Hypertension or Severe Coronary Artery Disease.
  • Hyperthyroidism, Phaeochromocytoma, or Angle-Closure Glaucoma.
  • Concurrent use of or use within 14 days of Monoamine Oxidase Inhibitors (MAOIs).

Population Restrictions and Cautions

  • Age-Based Rules: The medicine is not recommended for use in children under 12 years of age.
  • Pregnancy and Lactation: Use is not recommended during pregnancy and should not be used by breastfeeding women.
  • Conditional Use: Caution is advised for patients with non-severe hepatic or renal impairment, diabetes mellitus, or enlargement of the prostate gland. These groups should seek medical advice prior to use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines interactions formally documented in regulatory sources for this combination product (Acetaminophen, Phenylephrine, Caffeine, Ascorbic acid, and Terpinhydrate).


Contraindicated Combinations

The product is strictly contraindicated for use with Monoamine Oxidase Inhibitors (MAOIs), including use within 14 days of cessation of MAOI therapy, due to the risk of hypertensive crisis from Phenylephrine. Co-administration with other Sympathomimetic Amines (e.g., decongestants) or other Paracetamol-containing products is also prohibited.

Pharmacodynamic and Absorption Interactions

The Phenylephrine component may reduce the efficacy of Beta-blockers and other antihypertensives and may potentiate the hypertensive effect of Tricyclic Antidepressants and Ergot Alkaloids. Regarding absorption, Metoclopramide and Domperidone may increase the speed of Paracetamol absorption, while Colestyramine reduces it, requiring the products to be separated by at least 1 hour before or 4 hours after Colestyramine administration.

Metabolic and Substance-Related Risks

Probenecid is documented to decrease the clearance of Paracetamol by inhibiting conjugation. The risk of bleeding may be enhanced by prolonged regular daily use of Paracetamol with Warfarin and other Coumarins. Alcohol (ethanol) and Liver Enzyme Inducers (e.g., St John's Wort) are regulatory-listed factors that increase the risk of Paracetamol-related liver damage.

Mechanism of Action

Central Control of Thermoregulation and Nociceptive Signaling

The mechanism begins centrally: Acetaminophen selectively influences the Cyclooxygenase (COX) pathway primarily within the CNS, suppressing the synthesis of PGE2 mediators. This interaction targets the neurological systems governing pain signaling and thermoregulation, resulting in the downstream modulation of these pathways and the correction of the body's internal temperature set-point and central nociceptive signaling.


Regulation of Nasal Vascular Tone and CNS Arousal

The formulation engages the Autonomic Nervous System and CNS inhibitory pathways simultaneously. Phenylephrine acts as an alpha1 agonist on nasal blood vessels, causing targeted vasoconstriction that results in decreased local tissue edema. Concurrently, Caffeine antagonizes inhibitory Adenosine Receptors centrally, which modulates neural signaling to increase CNS psychomotor activity and influence central nociceptive pathways.


Modulation of Respiratory Secretion Dynamics

The mechanism influences respiratory secretion dynamics. Terpinhydrate directly stimulates Bronchial Secretory Cells, which alters the volume and viscosity of mucus. This effect facilitates the production of a thinner, more mobile fluid layer, thereby facilitating mucociliary clearance and the removal of fluid from the respiratory passages.

Dosage and Administration Information

Official Administration Protocol

The usage of Колдрекс is characterized by specific parameters for its administration route, dosage limits, and duration of use. This combination product is intended for oral administration and is typically used on an as-needed basis for acute symptoms, rather than a fixed daily schedule.


Standard Dosing and Frequency

Administration is indicated for adults and children aged 12 years and over. The standard dose is 1 to 2 tablets, or the contents of 1 sachet (powder form). To ensure proper dose management, subsequent doses should not be repeated more frequently than every 4 hours. The total daily intake is limited to a maximum of 8 tablets or 4 sachets over any 24-hour period. This limit is essential for managing the combined exposure to the active ingredients.


Administration Conditions and Constraints

For the powder dosage form, administration involves a specific preparation: the sachet contents are dissolved completely in hot water and consumed as a drink. Tablets are swallowed whole and administration is generally permitted independent of food. Usage is restricted to short-term treatment, and continuous use does not exceed 7 days. The product is not to be taken concurrently with any other medicine containing Paracetamol or sympathomimetics (decongestants). Furthermore, for individuals with severe renal or hepatic impairment, the dosing interval may be extended as part of the administration protocol.

Recent Clinical Evidence

Research evidence / Overview of Studies for Колдрекс

Evidence for Symptomatic Relief of the Common Cold and Flu

The approach of combining multiple active ingredients for cold and flu is used in research exploring how symptoms change over time, given that conditions like the common cold are characterized by fluctuating or episodic manifestations. This section will summarize the structure of Randomized Controlled Trials (RCTs) and meta-analyses that have been studied for the overall relief of cold and flu symptoms using multi-ingredient formulas. The populations primarily included in this research were generally healthy adults and older adolescents. The key areas research examined involved monitoring outcomes related to physical discomfort or systemic imbalance during the acute illness, using overall symptom scores reported by patients.

Studies have focused on short-term changes, specifically conducting research exploring short-term symptom changes, often over periods from a single dose up to about seven days. Findings describe patterns observed in the studies related to how the total symptom load evolved during this acute phase. However, the exact way "overall symptom burden" is defined and measured varies across studies, meaning there is high heterogeneity in the reported data.

Studies Focused on Pain, Fever, and General Discomfort

This sub-section will detail the research exploring the effects of the analgesic and antipyretic component (Acetaminophen) within the combination. This research was primarily conducted using RCTs and Systematic Reviews and was applied in studies examining patient-reported experiences of pain. The outcomes studied are patient-reported outcomes describing perceived discomfort, specifically focusing on pain intensity scales for symptoms like headache, muscle aches, and sore throat, as well as objective monitoring of body temperature for fever.

Studies Focused on Nasal Congestion and Sinus Pressure

This sub-section will outline the available clinical trials and physiological studies that research examined for the decongestant component (Phenylephrine). The research was applied in studies examining patient-reported experiences of congestion and focused on outcomes linked to inflammatory or irritative states in the nasal passages. Studies used both objective measures and subjective patient reports of feeling less congested or having reduced sinus pressure. Findings describe patterns observed in the studies related to a temporary alteration in nasal airflow and congestion scores, typically observed shortly after administration.

Key Studies & References

  1. Guidance document: Non-prescription Oral Adult Cough, Cold and Flu Labelling Standard (Health Canada)
  2. Guidance document - Nonprescription oral adult expectorant cough and cold labelling standard (Health Canada, used for Terpinhydrate evidence context)

Frequently Asked Questions (FAQ)

Common questions about Колдрекс (FAQ)


Q: Can I take Колдрекс if I only have a headache, not a cold?

The official product labeling states the medicine is indicated for the symptomatic relief of common cold and flu symptoms. These cold and flu symptoms often include headache and generalized pain. The regulatory purpose of this combination product is not described as being for use solely as a simple headache pain reliever.


Q: How long does it usually take for the effects of Колдрекс to start working?

Official information does not specify an exact timeframe for onset of action. However, studies on the decongestant component indicate that temporary changes in nasal airflow and congestion scores have been observed shortly after administration.


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

Official side effect documents list restlessness and difficulty sleeping as common effects of the medicine. Drowsiness is generally not listed in the common category. However, the labeling includes a specific warning that use should be avoided if a person experiences dizziness or drowsiness.


Q: Are there any common food or drink items that should not be consumed with Колдрекс?

Regulatory guidance specifically states that alcohol (ethanol) is a factor that increases the risk of paracetamol-related liver damage and is therefore discouraged. For the tablet form, administration is generally permitted independent of food. It is important to refer to all instructions on the product label regarding consumption.


Q: Is it possible to become dependent on Колдрекс if taken for a long time?

The official administration instructions strictly restrict the use of this medicine to short-term treatment. Continuous use must not exceed seven days, as described in regulatory documents. Regulatory sources do not provide information regarding the possibility of dependence for this specific product.


Q: Is the caffeine content in some versions of Колдрекс a concern?

Caffeine is an active ingredient in the medicine, classified as a psychostimulant. This component is associated with potential common side effects such as restlessness and difficulty sleeping. These effects are generally recognized in official labeling for stimulant-containing products.


Q: If I have a history of allergic reactions, is it safe to try Колдрекс?

Official labeling documents the possibility of severe allergic reactions, including hypersensitivity reactions and, rarely, Anaphylactic Shock. Official product information indicates that use is advised against if a person is known to be allergic to any of the active ingredients or other components. Individuals with known allergies are encouraged to check the full list of ingredients.


Q: Is it true that Колдрекс can sometimes cause feelings of anxiety?

Official regulatory summaries note side effects such as restlessness and excitability due to the presence of the phenylephrine component. Overdosage of the stimulant components has also been associated in some regulatory texts with feelings of anxiety or nervousness.


Q: Does the time of day matter when using Колдрекс?

The official administration protocol primarily mandates a minimum interval between doses and a maximum daily amount. However, because common side effects include restlessness and difficulty sleeping, official information does not recommend taking the product immediately before attempting sleep.


Q: What are the signs of taking too much Колдрекс?

Initial signs of paracetamol overdose in the first 24 hours may include pallor, vomiting, and abdominal pain. The most significant danger is liver damage, which may not become apparent until 12 to 48 hours after ingestion. Overdose of the phenylephrine component may also cause restlessness, high blood pressure (hypertension), and a fast or irregular heartbeat.


Q: Is it OK to take Колдрекс if I am also taking an allergy pill?

The product is prohibited for use with any other medicine containing sympathomimetic amines. These are decongestants, which are often found in certain allergy or cold medicines. Official documents specify that it is necessary to check the ingredients of any allergy pill to confirm it does not contain a sympathomimetic amine.


Q: Why do some forms of Колдрекс contain vitamin C?

Ascorbic acid (Vitamin C) is included in the formulation as an active ingredient. The official product information states that its inclusion is to address the replacement of vitamin C which may be lost in the initial stages of colds and flu.


Q: What are the documented long-term safety concerns associated with the use of Колдрекс components?

The product is restricted to short-term treatment, with continuous use limited to a maximum of seven days. Prolonged daily use of the paracetamol component alongside anticoagulants like warfarin is described in official sources as enhancing the risk of bleeding.


Q: Is it normal to sweat more after taking fever medicine like Колдрекс?

While often part of the body's response when a fever breaks, increased sweating (diaphoresis) is also documented as a potential side effect. This is associated with the effects of the Phenylephrine component.


Q: Are there any known interactions between Колдрекс and herbal supplements?

Official regulatory guidance specifically lists the herbal supplement St John's Wort. It is categorized as a liver enzyme inducer that may increase the risk of paracetamol-related liver damage. Co-administration of this supplement is stated that should be discussed with a healthcare professional.


Q: Is it safe to use Колдрекс if I have a history of asthma?

General asthma is not listed as an absolute contraindication in the official product overview. However, the labeling sometimes includes warnings that certain excipients (inactive ingredients) may cause allergic reactions including asthma, particularly in individuals with a history of allergy to aspirin or similar pain relievers.


Q: What is the risk of overdose with Колдрекс components?

The primary risk associated with excessive use is Severe Liver Damage/Failure, which is linked to the paracetamol component. Overdose of the other components, while generally considered less severe, can also cause effects such as high blood pressure, seizures, and irregular heart rhythms (arrhythmias).

How should Колдрекс be stored and disposed of?

Storing and Disposing of Coldrex According to Regulatory Guidelines

Storage Requirements

The official regulatory guidelines state that Coldrex (Колдрекс) must be stored out of the sight and reach of children for safety. The medicine is required to be stored at a temperature below 25 C or 30 C, depending on the specific national regulatory information, and protected from excessive heat, light, and moisture. To maintain stability, the product should remain in its original packaging until use.

Disposal Instructions

To protect the environment, unused or expired Coldrex should not be discarded via wastewater or standard household waste. Regulatory guidance directs users to consult a pharmacist for proper disposal procedures or to utilize authorized community drug take-back programs. The product must not be used after the expiration date printed on the packaging.

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

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