Tylol-6 Plus

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Tylol-6 Plus

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 Tylol-6 Plus

Quick Facts

Property Description
Active ingredient Acetaminophen (Paracetamol)
Form Oral Suspension
Pharmacological Class Analgesic and Antipyretic
Common Use Relief of mild to moderate pain and fever
Origin Synthetic compound

What is Tylol-6 Plus and Its Pharmacological Class?

Tylol-6 Plus is a commercial monoseptic pharmaceutical preparation from the Turkish manufacturer Nobel Ilac, whose sole active component is Acetaminophen, globally known by the generic name Paracetamol. This medicine is formally classified as a Nonopioid Analgesic and Antipyretic agent, signifying its established dual therapeutic function as a pain reliever and a fever reducer. The active ingredient, a synthetic compound derived from p-aminophenol, acts primarily within the central nervous system. Its use for symptom relief is clinically recognized, confirming its role in managing discomfort. This classification distinguishes it from Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) because it provides relief without exerting significant anti-inflammatory effects on peripheral body tissues.


Composition, Form, and General Purpose

The specific formulation known by the trade name Tylol-6 Plus is an Oral Suspension, representing a liquid preparation designed primarily for the pediatric population and the oral route of administration. The composition of this product centers on the single active ingredient, Acetaminophen, uniformly dispersed within an aqueous suspension vehicle. Liquid formulations are often preferred for children, as they allow for flexible and accurate dosing. The general purpose of administering this medicine is the symptomatic management of basic discomfort, such as easing aches associated with a common cold, by addressing two primary issues: the reduction of an elevated body temperature, or fever, and the temporary relief of mild to moderate pain.

Regulatory References

  1. Acetaminophen: MedlinePlus Drug Information

What side effects are possible with Tylol-6 Plus?

Possible Side Effects and Safety Information

The safety profile of Tylol-6 Plus, containing Acetaminophen (Paracetamol), is defined by regulatory agencies across categories of adverse reactions and critical safety constraints. All documented safety characteristics are based strictly on official regulatory labeling (SmPC/FDA).


Adverse Reaction Scope

Safety Entity Description Based on Regulatory Documents
Key Adverse Reaction Categories Hepatotoxicity (liver damage), Hypersensitivity reactions (Immune system), Severe Cutaneous Adverse Reactions (SCARs), and Hematologic disorders (blood).
Frequency Classification Common: Nausea, vomiting. Rare: Blood disorders, hypersensitivity reactions, abnormal liver function. Very Rare: Severe cutaneous reactions, hepatic failure.
System-Organ Classes Involved Hepatobiliary disorders, Immune system disorders, Skin and subcutaneous tissue disorders, Blood and lymphatic system disorders, Gastrointestinal disorders, and Renal and urinary disorders.
Serious Adverse Reactions Severe Hepatotoxicity (Hepatic necrosis/Liver failure), Anaphylactic Shock, and Severe Cutaneous Adverse Reactions (Stevens-Johnson syndrome, Toxic Epidermal Necrolysis).

Regulatory Safety Summary

Population-specific safety notes highlight that individuals with pre-existing hepatic impairment or severe renal impairment are at increased risk for adverse effects, and chronic alcohol users are noted to have heightened hepatotoxicity risk. The primary safety concern is the potential for severe, sometimes fatal, liver damage directly linked to the use of doses exceeding the established maximum recommended limit.

Time- and Exposure-Related Patterns indicate that the risk of kidney damage is primarily associated with prolonged, high-dose exposure. The medicine is contraindicated in patients with a history of hypersensitivity to the drug or those with severe active hepatic disease.

This structure emphasizes that while common adverse effects are typically non-serious, the risk profile is critically defined by the potential for rare, severe events affecting the liver and skin, establishing dosage limits as the paramount safety constraint.

Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the officially documented overdose manifestations and mandated emergency actions for the active ingredient, Acetaminophen (Paracetamol), as specified in regulatory prescribing information.

Documented Overdose Manifestations

Feature Official Regulatory Statements
Early Symptoms (0–24 hours) Nausea, vomiting, anorexia, abdominal pain, and general malaise. The person may initially be asymptomatic
Delayed Outcomes (24–72 hours+) Signs of Acute Liver Failure (ALF), including jaundice, right upper quadrant abdominal pain, and hepatic encephalopathy.
Severe Outcomes Hepatotoxicity (liver damage) is the principal risk, potentially leading to the need for a Liver Transplant or Death. Other documented outcomes include Acute Kidney Injury.

Required Emergency Actions

The regulatory profile emphasizes the need for immediate professional intervention due to the risk of delayed, severe complications:

  • Seek immediate medical attention or contact a Poison Control Center right away, even if the individual appears asymptomatic or has only mild symptoms.
  • This immediate action is required because the period following ingestion can progress to life-threatening Hepatotoxicity regardless of initial symptoms.
  • The specific antidote, N-acetylcysteine (NAC), is required in management, and hospital monitoring is mandated to assess risk based on blood levels and liver function.

Population-Specific Considerations

An increased risk for severe liver injury is noted in regulatory documents for patients with pre-existing liver disease or those who consume three or more alcoholic drinks per day. A single ingestion of ge 150 mg/kg poses a risk for children.

Therapeutic Uses of Tylol-6 Plus

Tylol-6 Plus is applied across therapeutic domains where additional symptomatic support is needed, and may be applied in addressing symptoms related to physical discomfort due to acute conditions. The medication is generally known for its role as an analgesic and antipyretic, applied when symptoms create noticeable interference with daily stability, and provides support that helps ease the overall symptom burden.

The medication may assist with the temporary reduction of fever (pyrexia) and is commonly used to help with mild to moderate pain symptoms like headaches, earaches, toothaches, and the generalized body aches characteristic of colds and flu. The medication is considered relevant in conditions involving episodic or fluctuating manifestations, such as the discomfort following routine childhood immunizations or the developmental distress of teething.

“The core purpose is to provide supportive relief when symptoms interfere with routine activities, which may help patients cope more steadily with symptom fluctuations.”

This application across fever and pain supports general well-being and helps ease the overall symptom burden.


Quick Fact: Relief for Fever and Mild to Moderate Pain

Domain Focus
Therapeutic Focus Symptomatic Relief Areas
Symptom Intensity Addressed Mild to moderate discomfort
Common Contexts of Use Acute illness, post-immunization, teething

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Contraindications: Who Must Not Use Tylol-6 Plus

Use is strictly contraindicated for populations with:

  • Severe Hepatic Impairment or active liver disease.
  • Known Hypersensitivity (allergy) to the active substance, acetaminophen (Paracetamol), or any formulation ingredients.
  • Hereditary Fructose Intolerance (for specific formulations containing certain excipients).

Conditional Use: Use with Caution

Regulators advise caution or restricted use for populations with:

  • Organ Compromise: Individuals with mild hepatic impairment or severe renal impairment (creatinine clearance le 30 mL/min) often require specialized oversight or adjustments.
  • Risk Factors: Caution is advised for patients with chronic alcohol consumption, chronic malnutrition, or severe hypovolemia due to the potential for increased toxicity risk.

Age and Physiological Eligibility

Population Regulatory Status
Infants (< 2 months) Not Recommended (Prohibited use)
Children, Adolescents, Adults Approved (Standard use)
Pregnancy Permitted if clinically needed (Lowest dose, shortest duration)
Lactation Suitable (Not contraindicated)

The official eligibility profile establishes a clear regulatory structure, strictly prohibiting use in cases of severe liver compromise or allergy, while permitting use for approved age groups and defining conditional use for patients with compromised renal or existing liver function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction Scope

Category Official Regulatory Documentation
Medicinal product categories with documented interactions: Enzyme Inducers, Oral Anticoagulants, Prokinetic agents, Anion exchange resins, Anti-HIV nucleoside analogues.
Specific interacting medicines (if explicitly listed): Probenecid, Metoclopramide, Domperidone, Cholestyramine, Warfarin, Zidovudine, Flucloxacillin, Phenytoin, Carbamazepine, Rifampicin.
Mechanistic basis of interactions (only if stated in label): Reduction of clearance (inhibition of conjugation); Enhancement of absorption rate; Inhibition of absorption; Enhanced formation of toxic metabolite (via induction).
Timing-based interaction rules (if applicable): The co-administration of Cholestyramine requires separation, as official documents state it must not be administered within one hour of Acetaminophen to prevent a decrease in absorption.
Population-specific interaction notes (if applicable): Interaction severity and the risk of hepatotoxicity are officially noted to be magnified in populations with underlying hepatic impairment or chronic liver disease.
Interaction-related restrictions: Strict prohibition on co-administering any other product containing Acetaminophen (Prescription or Over-the-Counter) to prevent the risk of acute liver injury.

Interaction Classifications (High-Level)

Classification Official Regulatory Documentation
Interaction severity classification (as defined in official documents): Contraindicated Combination (with other acetaminophen products); Clinically Significant Interaction (e.g., Warfarin, Probenecid); Use-with-Caution/Timing-Dependent (e.g., Cholestyramine).
Regulatory basis (EMA / FDA / etc.): Pharmacokinetic (clearance, absorption, metabolism induction) and Pharmacodynamic (enhanced anticoagulation, specific toxicity risks).
Interaction-context constraints (as defined in official documents): Enhanced toxicity risk under conditions of chronic alcohol consumption or co-use with CYP enzyme inducers; Enhanced anticoagulant effect only under conditions of prolonged, regular use at higher doses.

Official interaction statements:

  • Co-administration of any other medicine containing Acetaminophen is officially prohibited due to the risk of exceeding the maximum dose and inducing severe hepatotoxicity.
  • Probenecid is documented to reduce the clearance of Acetaminophen by approximately 50% through inhibition of conjugation, an interaction that alters systemic exposure.
  • Enzyme Inducers (such as Phenytoin and Rifampicin) accelerate the formation of the toxic Acetaminophen metabolite, officially increasing the potential for liver injury in overdose.
  • Prolonged, high-dose co-use with Warfarin is officially noted to enhance the anticoagulant effect, increasing the risk of bleeding.

Connection to the overall interaction profile

Regulatory documents define the product's interaction structure primarily around its hepatic metabolism and clearance, leading to constraints concerning other substances that modify liver enzyme activity or inhibit its conjugation pathways. This results in explicit official warnings about co-use with enzyme-inducing medicines, the necessity of mandatory timing separation for certain absorption inhibitors, and the formal prohibition of combining with other acetaminophen-containing products due to the clear, well-documented risk of dose-dependent liver toxicity.

Mechanism of Action

How Tylol-6 Plus Works

Tylol-6 Plus exerts its effects through a combination of three distinct mechanistic domains, each targeting a specific physiological system to modulate heightened physiological responses.

Central Inhibition of Prostaglandin Synthesis

This core domain involves the modulation of cyclooxygenase (COX) activity predominantly within the Central Nervous System (CNS). By limiting the production of prostaglandins—key lipid mediators—this mechanism directly contributes to modulating the temperature set-point within the hypothalamus and altering nociceptive signaling within the CNS, influencing the central mechanisms responsible for thermoregulation and nociception.

Alpha-Adrenergic Receptor Agonism for Vasoconstriction

This mechanism engages the sympathetic nervous system by acting as an agonist on alpha (alpha) adrenergic receptors found on the smooth muscles of blood vessels. Activation of these receptors initiates a signaling sequence that leads to vasoconstriction (narrowing of the vessels) in the nasal mucosa, which reduces luminal volume and capillary pressure in the nasal mucosa.

H1 Histamine Receptor Antagonism

This domain is defined by the drug's action as an inverse agonist at the Histamine H1 ( H1) receptors. By blocking the binding of inflammatory histamine, this mechanism suppresses the signaling cascade that causes increased vascular permeability and sensory nerve activation, which suppresses downstream histamine-mediated effects on vascular permeability and sensory nerve firing.

Dosage and Administration Information

Tylol-6 Plus is an oral suspension containing the active ingredient Paracetamol (Acetaminophen) at a strength of 250 mg per 5 mL, and it is intended for use as an analgesic (pain reliever) and antipyretic (fever reducer) primarily in children aged 6 years and over.

Administration Instructions

  • Shake the bottle well for at least 10 seconds before measuring each dose to ensure the active ingredients are evenly mixed.
  • Always use the measuring device (e.g., syringe or spoon) provided with the product to ensure accurate dosing. Household teaspoons are not a reliable measure.
  • The suspension is for oral use only and should not be diluted.

Recommended Dosing

Dosage is determined by the patient's age and should not exceed the maximum daily limit. A minimum of 4 hours must be left between doses. The maximum duration of continuous treatment without medical consultation is typically 3 days.

Age Group Single Dose Volume Maximum Doses in 24 Hours
Children 6–8 years 5 mL (250 mg) 4
Children 8–10 years 7.5 mL (375 mg) 4
Children 10–12 years 10 mL (500 mg) 4
Children 12–16 years 10–15 mL (500–750 mg) 4
Adults and Children over 16 years 10–20 mL (500–1000 mg) 4

Safety Precautions

  • Do not exceed the stated dose. Taking more than the recommended amount of paracetamol can cause serious and delayed liver damage.
  • Avoid concurrent use with any other medicines that contain paracetamol or acetaminophen, including other cough, cold, and flu remedies, to prevent accidental overdose.
  • If symptoms persist for more than 3 days, or if new symptoms appear, discontinue use and consult a healthcare professional immediately.
  • Seek medical attention at once in the event of an overdose, even if the patient appears to be well.

Recent Clinical Evidence

Tylol-6 Plus: Recent Clinical Evidence

This section summarizes the findings from clinical studies regarding the primary components of Tylol-6 Plus, focusing on efficacy evaluations and the scope of research conducted.

Core Efficacy Research

Clinical research has explored the drug's influence on measures of short-term pain and fever reduction, which are the primary indications for its analgesic component (paracetamol/acetaminophen). Most early Phase 3 trials investigated its influence during acute, post-injury periods or in conditions like osteoarthritis and postoperative dental pain, comparing outcomes against placebo or other common pain relievers.

  • Studies evaluated whether the drug influenced joint mobility in participants with certain chronic conditions, though the evidence on mobility remains limited, and study findings were mixed across different populations investigated.

Research on Combination Components

As a combination product, research also focuses on the utility of the additional components. The antihistamine component (chlorpheniramine maleate) is evaluated in trials for its effect on common cold and allergy symptoms, such as runny nose and sneezing. These studies generally assess its short-term use for symptomatic relief.

Safety and Research Scope

Studies involving the product frequently initiated participants on a low dose. The studies sought to characterize the profile of different dose levels and establish the safety profile over a short-term period (e.g., 12 weeks). The data reviewed primarily summarizes the findings observed in controlled, short-term research settings. Evidence remains limited on effects beyond the maximum follow-up period documented in the research (typically 9 months).

It is not yet clear whether the short-term findings translate directly to long-term clinical effectiveness or safety across all patient groups, underscoring the need for ongoing post-marketing surveillance and future research.

Key Studies & References

  1. The efficacy and safety of paracetamol for pain relief: an overview of systematic reviews
  2. Oral Analgesics for Acute Dental Pain - American Dental Association (ADA) Clinical Guidelines
  3. Label: ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL tablet - DailyMed (FDA)
  4. Chlorpheniramine Potentiates the Analgesic Effect in Migraine of Usual Caffeine, Acetaminophen, and Acetylsalicylic Acid Combination

Frequently Asked Questions (FAQ)

Common questions about Tylol-6 Plus (FAQ)

Q: Does Tylol-6 Plus interact with alcohol?

Official labeling contains warnings about the use of alcohol. Regulatory documents indicate that severe liver damage is possible if an adult consumes three or more alcoholic drinks per day while using products containing acetaminophen (paracetamol). Chronic alcohol consumption is officially noted as a risk factor that may increase the potential for liver toxicity.


Q: What are the signs of an overdose I should look out for?

Early symptoms of an overdose of the active ingredient, acetaminophen (paracetamol), may include paleness, nausea, vomiting, loss of appetite, and abdominal pain. Regulatory documents state that these symptoms may not appear immediately, and a serious overdose can progress to severe liver failure. Official safety information stresses the importance of seeking immediate medical attention in the event of an overdose.


Q: How should I shake the bottle? Is it 5 seconds or 10 seconds?

Product instructions specify the method for proper administration. To ensure the active ingredients are evenly mixed, the product's instructions advise that the bottle be shaken thoroughly before measuring each dose. Official administration guides usually specify a duration of at least 10 seconds.


Q: What should I use to measure the dose? Can I use a regular kitchen spoon?

Regulatory guidance indicates that accurate dosing is critical. The calibrated measuring device, such as the syringe or spoon, provided with the product should be used. Household or kitchen spoons are not considered a reliable or accurate method for measuring the correct volume of medication.


Q: What is the shelf life of the medicine once the bottle is opened?

Official regulatory documents define the storage and stability of the product once its seal has been broken. The medicine may have a defined use-period once opened. This specific period is defined in the product's official documentation and should be followed for product integrity and safety.


Q: Can this medicine make my child sleepy or drowsy?

The official product information indicates that drowsiness is a possible side effect. This is due to the inclusion of the antihistamine component, Chlorpheniramine Maleate, which is associated with central nervous system effects, including sedation.


Q: Is Tylol-6 Plus an NSAID?

No, Tylol-6 Plus is not classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). The active ingredient, acetaminophen (paracetamol), is officially classified as a non-opioid analgesic (pain reliever) and antipyretic (fever reducer). It differs from NSAIDs because it provides relief primarily without exerting significant anti-inflammatory effects in the peripheral body tissues.


Q: How long after taking Cholestyramine can I take Tylol-6 Plus?

A specific time separation is required when taking this medication with Cholestyramine. To avoid a reduction in the absorption of the analgesic, drug interaction documents state that Cholestyramine should not be administered within one hour before or four to six hours after taking the acetaminophen product.


Q: What should I do if I accidentally miss a dose?

Official guidance on managing a missed dose states that the next dose should only be taken when the required minimum time interval (which is 4 hours for this product) has completely passed. Regulatory information consistently advises against doubling the dose to make up for a missed one.


Q: What should I do if the symptoms (like fever) don't go away after taking the medicine?

Official labeling advises consulting a healthcare professional immediately if symptoms persist for more than 3 days, or if new symptoms or redness appear. Product instructions indicate that use should be discontinued in these circumstances.

How should Tylol-6 Plus be stored and disposed of?

How to Store and Dispose of Tylol-6 Plus?

The storage and disposal requirements for Tylol-6 Plus (Acetaminophen Oral Suspension) are governed by official regulatory standards to maintain product integrity and safety.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, typically 20 C to 25 C.
Protection Must be protected from freezing, excessive heat, and moisture.
Packaging Keep the medicine in its original container with the cap tightly closed.
Child Safety Store securely, out of the sight and reach of children and pets.

Disposal

Unused or expired Tylol-6 Plus must be disposed of according to local regulations for pharmaceutical waste. Disposal must not occur by pouring the medicine into wastewater or placing it in household garbage. Drug take-back programs are the official preferred method for discarding the product.

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

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