Afebryl

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Afebryl

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Method of action: Analgesic

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Medically reviewed

Marina Burgos

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 Afebryl

Property Description
Active Ingredients Paracetamol, Acetylsalicylic Acid, Ascorbic Acid
Form Effervescent Tablet
Pharmacological Class Non-opioid Analgesic and Antipyretic
Common Use Relief of general pain and fever associated with cold/flu
Origin Synthetic

What Type of Medicine is Afebryl?

Afebryl is an over-the-counter combination medicine categorized as a Non-opioid Analgesic and Antipyretic. This classification means its fundamental role is to provide simultaneous relief from both generalized pain and elevated body temperature. This approach to symptom management utilizes combination therapy intended for the relief of flu-like symptoms.

This medicine is a synthetic product, meaning its active components are manufactured through chemical processes. Its unique identity lies in its specific three-ingredient combination and its market positioning as a cold and flu remedy, differentiating it from single-agent analgesics. Its primary, high-level purpose is to offer symptomatic relief for the overall discomfort often associated with cold or flu states.

What is Afebryl Made of and What Form Does It Take?

The effervescent tablet form of Afebryl contains a blend of three key components: Paracetamol (Acetaminophen) and Acetylsalicylic acid (Aspirin) as the main therapeutic agents, and Ascorbic acid (Vitamin C). The inclusion of both Paracetamol and Acetylsalicylic acid targets different aspects of pain and fever management, providing a broad-spectrum approach to relief.

Afebryl is formulated as an effervescent tablet designed for oral consumption after being fully dissolved in water. This preparation creates an aqueous solution, a delivery method that is distinct from swallowing a solid pill and may be preferred by individuals experiencing throat irritation or difficulty swallowing.

What is the General Purpose of Afebryl?

Afebryl's general purpose is to quickly reduce the feeling of generalized aches, muscular discomfort, and an elevated body temperature. The medicine helps make the patient feel more comfortable and stabilized. The main benefit of this combination is the convenience of addressing the two most common symptoms of malaise (pain and fever) with one preparation, thereby managing symptoms associated with a typical cold or viral condition.

Regulatory References

  1. NIH Acetaminophen & Aspirin

What side effects are possible with Afebryl?

Possible Side Effects and Safety Information

The safety profile of Afebryl, a combination containing Paracetamol, Acetylsalicylic Acid, and Ascorbic Acid, is defined by the established adverse reaction profiles of its active components, as documented in official government regulatory sources.


Official Adverse Reactions by System and Frequency

Adverse effects are categorized by the System Organ Class (SOC) affected and their frequency, based on regulatory standards. Serious reactions are generally classified as Very Rare (fewer than 1 in 10,000) or Not Known.

System Organ Class (SOC) Frequency Classification Officially Listed Adverse Reactions
Hepatobiliary Disorders Very Rare Hepatic Dysfunction, Hepatitis
Blood & Lymphatic Disorders Very Rare Thrombocytopenia, Agranulocytosis, Blood Dyscrasias
Immune System Disorders Very Rare / Not Known Hypersensitivity reactions, Anaphylactic Shock
Skin Disorders Very Rare Serious Skin Reactions (e.g., SJS, TENS)

Serious Safety Considerations

Regulatory documents highlight several serious outcomes, including Hepatic Failure (associated with overdose of Paracetamol), Anaphylactic Shock, and Acute Renal Failure.

Population-Specific Constraints and Restrictions

Official labeling includes explicit constraints for specific populations and use conditions:

  • Hepatic and Renal Impairment: Caution is necessary, and dosing may be constrained for individuals with pre-existing hepatic insufficiency (e.g., Gilbert's syndrome) or renal insufficiency.
  • Other Paracetamol Products: The product must not be taken concurrently with any other Paracetamol-containing product to prevent the risk of severe liver damage.
  • Alcohol: Alcohol consumption is restricted during treatment.
  • Duration Patterns: The risk of enhanced anticoagulant effects and bleeding is specifically associated with prolonged regular daily use of the Paracetamol component.

Overdose and Emergency Response

The official regulatory profile for Afebryl overdose focuses on the severe, time-dependent risks posed by its Paracetamol and Acetylsalicylic Acid components. Immediate medical attention must be sought following any suspected ingestion beyond the recommended dose, even if symptoms are not yet present, and urgent hospital referral is required.

Overdose may initially present with non-specific signs such as pallor, nausea, vomiting, and abdominal pain. The most life-threatening outcome from the Paracetamol component is delayed hepatic necrosis and acute hepatic failure, typically manifesting 48 to 72 hours after ingestion. Salicylate toxicity is associated with symptoms like tinnitus, hyperventilation, and the development of severe metabolic acidosis and neurological symptoms.

Management requires urgent action, including potential administration of the specific antidote, N-acetylcysteine (for Paracetamol toxicity), or procedural measures such as urinary alkalinization and hemodialysis (for severe salicylate toxicity). Monitoring of plasma paracetamol concentration and serum salicylate levels is required. Specific population risks include greater hepatic toxicity in patients with chronic alcoholism or liver disease and the risk of Reye's Syndrome in pediatric patients.

Therapeutic Uses of Afebryl

What Afebryl Treats: Main Uses and Benefits

Afebryl is commonly used in situations involving certain distressing symptoms associated with acute episodes, such as the common cold and flu. The therapeutic areas of use for its core ingredients are relevant for easing mild to moderate pain and supporting the management of fever. The core benefit provided is supportive relief for both symptoms related to systemic imbalance (fever) and symptoms related to physical discomfort (aches and pains).

This approach may assist with easing the overall symptom load and contributes to improved comfort during periods of heightened symptoms. The medication is relevant for managing symptom clusters that may become intense or disruptive, is used for managing symptoms that interfere with daily comfort, such as general muscular discomfort, systemic aches, and febrile manifestations.


Quick Fact: Relief for Dual Discomfort

Afebryl is applied in clinical settings that involve acute or unstable symptom patterns. It provides supportive relief when symptoms create noticeable physiological strain and may help patients cope more steadily with symptom fluctuations.

Regulatory References

  1. NIH MedlinePlus Drug Information on Acetaminophen

Eligibility and Restrictions for Use

Eligibility for Afebryl Use

Afebryl, a combination medicine containing Paracetamol, Acetylsalicylic Acid (ASA), and Ascorbic Acid, is subject to regulatory restrictions based on age, physiological status, and underlying medical conditions. The medicine is generally permitted for use by adults and adolescents aged 12 years and older who have no contraindications.


Contraindicated Populations (Must Not Use)

Population Group Reason for Prohibition (Regulatory)
Children under 16 Contraindicated with fever or viral illness due to ASA risk of Reye's Syndrome (a severe condition)
Severe Organ Impairment Patients with severe hepatic failure, severe renal insufficiency, or severe heart failure
Bleeding Risks Individuals with active peptic ulcers, gastrointestinal bleeding history, or haemorrhagic diathesis
Reproductive Status Women in the third trimester of pregnancy and women who are breastfeeding
Other Known hypersensitivity to any component; G6PD deficiency

Restricted or Conditional Use

Use of Afebryl requires caution and potential restriction for patients with mild to moderate hepatic or renal impairment, chronic alcoholism, or bronchial asthma. Usage in the first and second trimesters of pregnancy is restricted to situations where the need is clearly established and must be for the shortest possible duration.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define specific interaction patterns for Afebryl's active components, Paracetamol (Acetaminophen) and Acetylsalicylic Acid (Aspirin). These interactions are classified based on their effect on exposure or risk.

Documented Interaction Patterns

Interaction Type Interacting Substances (Examples) Official Regulatory Outcome
Contraindicated High-dose Methotrexate (ge 15 mg/week) Increased Methotrexate plasma concentration and toxicity risk.
Pharmacodynamic Anticoagulants, Thrombolytics Increased risk of bleeding due to additive effects.
Metabolic Hepatic Enzyme Inducers (e.g., Carbamazepine, Phenytoin) Increased risk of Paracetamol-induced hepatotoxicity through enhanced metabolite formation.
Absorption/Clearance Lithium, Metoclopramide Altered exposure (e.g., increased plasma concentration of Lithium; faster absorption of Paracetamol).
Timing-Separation Cholestyramine Requires administration separation by at least one hour to prevent reduced Paracetamol absorption.

Product and Population Constraints

Co-administration with Alcohol, particularly chronic heavy use, significantly increases the documented risk of Paracetamol-related liver toxicity. The regulatory profile also notes that the use of Acetylsalicylic Acid with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs) carries an increased risk of gastrointestinal adverse events. For patients with hepatic impairment or chronic alcoholism, the severity of metabolic interactions that increase the risk of hepatotoxicity is officially heightened. All interaction statements adhere strictly to the information presented in government-approved labeling.

Mechanism of Action

Modulation of Central Temperature Regulation

This mechanism addresses the physiological process of elevated temperature by targeting the brain's internal thermal control center. The active ingredients suppress the synthesis of key signaling molecules, specifically Prostaglandin E2 (PGE2), within the hypothalamus. By reducing PGE2 concentration, the brain’s thermal set point is modulated and triggers the body's natural heat-loss mechanisms, such as vasodilation and sweating. This mechanism facilitates systemic heat dissipation.


Dual Interference with Nociceptive Signaling Pathways

The product acts via complementary pathways to modulate nociceptive signaling. Acetylsalicylic Acid (Aspirin) exerts peripheral action by reducing prostaglandins that sensitize peripheral nerve endings, while Paracetamol (Acetaminophen) primarily acts centrally. Paracetamol's central mechanism involves inhibiting Cyclooxygenase activity in the CNS and modulating descending inhibitory pain signals, which alters the threshold for nociceptive perception. This combination acts upon both peripheral nociceptor sensitization and central neuronal signaling cascades.


Mechanistic Constraints and Specificity

The mechanism of Paracetamol is chemically sensitive to high levels of peroxides, typically found in acutely inflamed peripheral tissue. This mechanistic constraint limits the mechanism's ability to inhibit COX activity in inflamed peripheral tissue, focusing its primary action on central pathways rather than the full peripheral inflammatory cascade. The resulting modulation of discomfort and temperature is therefore not accompanied by a robust local blockade of peripheral inflammation.

Dosage and Administration Information

Official Administration Guidelines for Afebryl

Afebryl is strictly administered via the oral route as a prepared solution, a procedural requirement defined by the effervescent tablet form.

Preparation and Administration

The tablet must be completely dissolved in half a glass of water before being consumed. Stirring lightly ensures full dissolution, and the resulting solution must be drunk immediately. The scored tablet can be divided for accurate dose measurement when required. No explicit instruction regarding administration timing with respect to meals is provided in the available product information.

Standard Dosing and Schedule

The dosing regimen is based on the specific combination strength of 200 mg Paracetamol and 300 mg Acetylsalicylic Acid:

Population Standard Single Dose Frequency & Interval Maximum Duration
Adults & Adolescents (≥12 years) 1 tablet 1 to 4 times per day; minimum interval of 4 hours. 10 days
Children (2 to 12 years) 1/2 tablet 1 to 4 times per day; minimum interval of 4 hours. 5 days

The maximum allowed dose for adults is 6 tablets within any 24-hour period. The label requires dose reduction or a prolongation of the dosing interval for patients with known reduced hepatic or renal function, reflecting a necessary adjustment to the standardized regimen. The medication is intended for use as short as possible to manage the acute symptomatic period, never for long-term use without medical guidance.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Afebryl

The research evidence for Afebryl is based primarily on studies examining its core active ingredients: Paracetamol (Acetaminophen) and Acetylsalicylic Acid (Aspirin), which are classified as non-opioid analgesics and antipyretics. The evidence provides insight into how these ingredients were observed in relation to common symptoms, and what remains uncertain about the specific three-component formulation.


Evidence for Relief of Common Cold and Flu Symptoms

Research examined how the components were used in studies exploring patient-reported experiences related to flu-like symptoms. These studies often focused on conditions involving periods of heightened symptoms, such as headache and muscular aches, that are outcomes related to systemic or functional imbalance. Findings were mixed for overall symptom severity, especially concerning the role of Ascorbic Acid (Vitamin C) as a treatment used after cold symptoms have already begun.

What Studies Examined for Overall Symptom Change

Short-term randomized controlled trials (RCTs) typically monitored patient-reported outcomes describing perceived discomfort over periods of only a few days. Research examined the use of the combination's core agents in studies conducted during periods of increased symptom activity. Results apply only to the populations studied and do not definitively determine whether an individual will respond similarly.


Evidence for the Management of Fever (Antipyresis)

Studies explored the time required to achieve a measurable change in body temperature and the duration over which that change was observed, which are outcomes related to systemic or functional imbalance. The research describes that the active components were observed in some studies to be associated with this temporary physiological imbalance. The evidence contributes to the broader evidence landscape of how these components are studied in the context of fever.


What Remains Uncertain About the Research Landscape

A primary limitation is that comparative evidence is lacking for the specific three-component formula (Paracetamol, Aspirin, and Vitamin C) against similar dual-agent or single-agent products across all measured outcomes. Furthermore, the certainty remains low regarding the full understanding of outcomes reflecting daily functioning, and subgroup findings are uncertain for certain vulnerable populations, such as older adults, as the combination has been primarily studied in adult populations.

Key Studies & References Acetaminophen and aspirin drug information

Frequently Asked Questions (FAQ)

Common questions about Afebryl (FAQ)

Q: Is Afebryl primarily for flu symptoms, or can it be used for other types of pain and fever?

Afebryl is indicated for the symptomatic treatment of general pain and fever. While it is often marketed for cold and flu symptoms, the active ingredients are effective for a range of discomforts, including common headaches and other types of mild to moderate pain, according to official product information.

Q: What are the most common but mild side effects people report when taking Afebryl?

According to official regulatory information for its ingredients, common mild side effects reported for the components Paracetamol and Acetylsalicylic Acid can include nausea, vomiting, and constipation. For Acetylsalicylic Acid specifically, some users may also experience stomach discomfort or epigastric pain.

Q: Is there a risk of stomach irritation when taking Afebryl due to the acetylsalicylic acid content?

Yes, there is a risk of stomach irritation. The Acetylsalicylic Acid component is associated with potential gastrointestinal discomfort. Regulatory information states the medicine is contraindicated (should not be used) by individuals with active peptic ulcers or a history of gastrointestinal bleeding.

Q: Are there any specific foods or drinks that should be avoided while taking Afebryl?

The use of Alcohol is officially restricted or contraindicated during treatment, as this combination significantly increases the documented risk of Paracetamol-related liver toxicity. Additionally, using this medicine alongside other Nonsteroidal Anti-inflammatory Drugs (NSAIDs) should be done with caution due to the increased risk of stomach issues.

Q: Does Afebryl interact with common supplements like magnesium or multivitamins?

Official regulatory documents primarily list drug-to-drug interactions. However, supplements containing minerals like magnesium may interfere with how the body absorbs the medicine. A separation of administration time by several hours is sometimes recommended to avoid potential reductions in absorption.

Q: Is there a concern about taking Afebryl near the time of a minor dental procedure or surgery?

Yes, there is a concern due to the Acetylsalicylic Acid component, which can affect blood clotting and carries a documented risk of bleeding. The decision to temporarily stop the medicine before any procedure is a clinical decision that requires guidance from a healthcare professional.

Q: Can Afebryl cause drowsiness or affect my ability to concentrate?

Regulatory documents state that the medicine has no or negligible influence on the ability to drive or use machines. The active ingredients are not typically associated with causing drowsiness at standard doses. However, if rare side effects like dizziness or headache occur, these symptoms may affect concentration or safe driving.

Q: Is Afebryl an anti-inflammatory medicine, or just an analgesic and antipyretic?

Afebryl is primarily classified as an analgesic (pain reliever) and an antipyretic (fever reducer). While the Acetylsalicylic Acid component has anti-inflammatory properties, the Paracetamol component has limited action against peripheral inflammation. The medicine is not typically considered a primary treatment for severe inflammation.

Q: Is there a risk of interaction if I am taking daily low-dose Aspirin for heart health?

Combining the acetylsalicylic acid in Afebryl with other salicylates, including low-dose Aspirin, is often cautioned against in regulatory documents. This combination may increase the documented risk of side effects, particularly gastrointestinal events, and must be reviewed by a healthcare professional.

Q: Does Afebryl interact with common heartburn medications or antacids?

Yes, interactions are possible. Some antacids may speed up the body's elimination of the acetylsalicylic acid component. Additionally, certain products like Cholestyramine can reduce the absorption of the Paracetamol component and require a separation of administration time by at least one hour.

Q: Can Afebryl be used for pain relief from menstrual cramps?

Official product information for the active ingredients, Paracetamol and Acetylsalicylic Acid, indicates that they are commonly used for the relief of mild to moderate pain. This generally includes common types of discomfort such as headaches, muscle aches, and period pain (menstrual cramps).

Q: Does Afebryl interfere with the effectiveness of any common antibiotics?

Regulatory information indicates interactions with certain drugs, including some that are used as antibiotics. For instance, co-administration with Flucloxacillin is cautioned against in some patients due to a rare metabolic risk. Official documentation notes that users should ensure their healthcare provider is aware of all concomitant medications.

Q: Does the Ascorbic Acid (Vitamin C) in Afebryl help with cold or flu symptoms directly?

Ascorbic Acid (Vitamin C) is included as an active ingredient, but its direct function in this combination for symptomatic relief is not fully defined in official documents. Some research evidence summaries regarding its use once cold symptoms have begun report mixed findings for direct therapeutic benefit.

Q: Why is it important to consider the sodium content of effervescent tablets like Afebryl?

Effervescent tablets use sodium (salt) to create the fizzing action, resulting in a significant sodium load (e.g., approximately 315 mg per tablet). Patients who are on a strict salt-free or low-sodium diet must take this additional sodium intake into account, as stated in official warnings.

Q: Could taking Afebryl occasionally affect my blood pressure?

Official warnings note that the Acetylsalicylic Acid component is known to potentially cause some sodium and water retention. This effect is a caution for patients who have pre-existing conditions like uncontrolled high blood pressure (hypertension) or heart failure.

Q: Can the lemon oil excipient in Afebryl cause any allergic reactions?

The official product information lists the lemon essential oil as an excipient (non-active ingredient). The medicine is contraindicated in individuals with known hypersensitivity to any of its components, which includes both the active ingredients and excipients.

Q: What are some less common but possible skin reactions associated with Afebryl’s ingredients?

Less common skin reactions associated with the ingredients may include a general rash or pruritus (itching). Official documents also warn about the possibility of rare but very serious skin reactions, such as Stevens-Johnson Syndrome (SJS).

Q: Is it normal to notice undissolved particles at the bottom of the glass after taking Afebryl?

Official administration guidelines state that the tablet must be completely dissolved in water, and light stirring is recommended to ensure full dissolution before consumption. While the final solution may not be fully clear, a noticeable, undissolved tablet piece suggests the preparation process was incomplete.

Q: Can Afebryl affect blood sugar levels, especially in patients with diabetes?

Yes, there is an interaction risk. The Acetylsalicylic Acid component may enhance the effect of certain medications used to treat diabetes (sulfonylureas). Caution is required for patients with diabetes mellitus using this product, as a dose adjustment of the antidiabetic drug may be necessary.

Q: Are there certain inherited conditions where Afebryl use is contraindicated?

Yes. The medicine is contraindicated in individuals with the genetic condition glucose-6-phosphate dehydrogenase (G6PD) deficiency due to the documented risk of haemolytic anemia. Caution is also advised for patients with a liver condition known as Gilbert’s Syndrome.

Q: Is it safe to drive or operate machinery after taking Afebryl?

Regulatory documents state that the medicine has a negligible influence on the ability to drive or use machines. However, if an individual experiences any side effects that could impair their judgment, such as dizziness or a headache, they should refrain from these activities.

Q: Are there any expected changes in urine color or frequency after taking Afebryl?

High doses of the Ascorbic Acid (Vitamin C) component may cause mild and temporary gastrointestinal effects, which could include a slight increase in urinary frequency. The Paracetamol component may also affect the results of certain laboratory tests for blood sugar and uric acid.

Q: Why are patients with a sodium-restricted diet cautioned about taking effervescent Afebryl?

This caution is necessary because effervescent tablets contain sodium to create the fizzing action, leading to a significant sodium load (approximately 315 mg per tablet). Patients on a strict low-sodium or salt-restricted diet must consider this intake as an official warning.

Q: How does the effervescent nature of Afebryl tablets influence its absorption rate?

Afebryl is formulated as an effervescent tablet which is completely dissolved in water, forming an aqueous solution. This method of administration typically results in the faster absorption of the active ingredients by the body compared to swallowing a traditional solid tablet.

How should Afebryl be stored and disposed of?

Afebryl Effervescent Tablets must be stored under specific environmental constraints to maintain their efficacy and stability. The medicine must be kept at a temperature below 25 C and requires active protection from both moisture and light. To achieve this, the product must remain in its original container, which should be kept tightly closed after each use. Once the container is opened, the tablets should be used within 6 months.

For safety, the medicine must be kept out of the sight and reach of children at all times.

Disposal must adhere to pharmaceutical waste standards: any unused or expired Afebryl must be disposed of in accordance with local regulations and should not be thrown away via wastewater or household waste.

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

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