Daleron (Acetaminophen)

Quick links to important sections

Daleron (Acetaminophen)

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 Daleron (Acetaminophen)

As a single-component pharmaceutical preparation, Daleron is defined by its active substance, Acetaminophen, commonly known as Paracetamol. This medicine is broadly classified as a non-opioid analgesic and an antipyretic, functions that contribute to managing pain and fever.


Quick Facts

Property Description
Active ingredient Acetaminophen (Paracetamol)
Forms Tablets, Capsules, Oral solution, Suppositories, Injectable solution
Pharmacological class Non-opioid analgesic / Antipyretic
Common use Relief of pain and fever (pyrexia)
Origin Synthetic para-aminophenol derivative

Definition and Pharmacological Classification

Daleron contains the sole active ingredient Acetaminophen, chemically identified as N-(4-hydroxyphenyl)acetamide. It is a synthetic compound derived from the para-aminophenol chemical class, setting it apart chemically from other major analgesic groups. Acetaminophen is utilized clinically to manage general discomfort and reduce body temperature. Daleron is typically available as an over-the-counter (OTC) medicine, positioning it for immediate access by the general population for symptomatic relief of conditions such as headaches or muscle aches.

Composition, Forms, and General Therapeutic Purpose

This active substance is available in several drug forms, including solid preparations like tablets and capsules, liquid formulations such as oral solution, and specialized injectable solution for alternative routes of administration. As both an analgesic and antipyretic, Acetaminophen acts primarily on the Central Nervous System (CNS) to raise the pain threshold and affect the hypothalamic heat-regulating center. The overall therapeutic goal of Daleron is the reliable relief of mild to moderate pain and the effective reduction of elevated body temperature (fever or pyrexia).

Regulatory References

  1. National Library of Medicine (NIH) MedlinePlus
  2. NIH StatPearls Monograph on Acetaminophen

What side effects are possible with Daleron (Acetaminophen)?

The safety profile of Daleron (Acetaminophen) is established through regulatory classifications based on clinical data and post-marketing surveillance, defining the incidence and nature of potential adverse events. The regulatory structure places primary emphasis on the risk of liver damage and severe skin reactions.


Adverse Reaction Scope

Category Description
Key Adverse Reactions Liver damage (Hepatotoxicity), Severe skin reactions, and specific Blood/Immune system disorders.
Frequency Classification Adverse effects are classified into official categories such as Common (e.g., nausea, vomiting, headache) to Rare (e.g., thrombocytopenia, specific blood disorders) and Very Rare (e.g., severe hepatotoxicity, SJS/TEN).
System-Organ Classes Effects are formally mapped to Hepatobiliary disorders, Skin and Subcutaneous Tissue disorders, and Blood and Lymphatic System disorders as primary safety focus areas.
Serious Adverse Reactions Regulatory documents explicitly identify Acute Liver Failure/Hepatotoxicity and Severe Cutaneous Adverse Reactions (SCARs) (e.g., Stevens-Johnson Syndrome) as critical, potentially fatal risks.

Safety Constraints and Special Populations

Official labeling defines specific use boundaries and restrictions:

  • Population-Specific Restrictions: Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease. Caution is advised in cases of severe renal impairment, chronic malnutrition, and for those who regularly consume alcohol in excess.
  • Exposure-Related Constraints: The most critical regulatory constraint is that the risk of severe liver damage is directly linked to acute overdose or cumulative supratherapeutic doses over time, applying to all forms of the medicine.

The official safety information structures the understanding of risks by categorizing adverse reactions by frequency and physiological system, clearly identifying severe hepatotoxicity and SCARs as the most serious, though rare, possibilities. This profile mandates strict adherence to dose limits and dictates the formal contraindication of the medicine in specific patients.

Overdose and Emergency Response

Acetaminophen (Daleron) overdose is officially documented as a severe risk associated with delayed, progressive liver damage (hepatotoxicity), which can escalate to Acute Hepatic Failure and subsequently result in death. Early clinical manifestations are often non-specific, including nausea, vomiting, pallor, and abdominal pain, and these do not reliably indicate the severity of the underlying intoxication. More serious, delayed presentations may involve jaundice, encephalopathy, acute renal failure, and laboratory evidence of coagulopathy.

Immediate medical advice must be sought and the individual referred to a hospital urgently for immediate medical attention, even if the patient feels well, due to the critical nature of delayed life-threatening complications. Regulator guidance emphasizes contacting a Poison Help center right away. The specific antidote is N-acetylcysteine (NAC), and its time-critical administration is guided by plasma Paracetamol concentration measurements and the Rumack-Matthew Nomogram.

A greater overdose hazard is officially documented in patients with factors like non-cirrhotic alcoholic liver disease or those with glutathione depletion. Supportive treatment may involve the use of activated charcoal if administered within one hour of ingestion, as part of the symptomatic and supportive management procedures described in regulatory documentation.

Therapeutic Uses of Daleron (Acetaminophen)

What Daleron (Acetaminophen) Treats: Main Uses and Benefits

Daleron (Acetaminophen) is commonly used across conditions presenting with systemic or localized discomfort, and is applied across domains where additional symptomatic support is needed. The core therapeutic focus is the management of pain and fever. This medication is applicable within clinical settings that involve acute or disruptive symptom patterns where short-term symptomatic assistance is generally considered relevant.

It helps address symptom clusters that may become intense or disruptive, such as episodic headaches, temporary muscular aches, menstrual cramps, and the elevated body temperature associated with the common cold or flu. Applying this medication provides support that helps ease the overall symptom burden, and may assist with maintaining functional stability.

Clinical Focus and Benefit

The medication is commonly used across conditions presenting with acute episodes in specific patient populations, including pediatric patients and pregnant or breastfeeding women. For these groups, it is generally considered relevant for supportive symptom management. By addressing symptoms related to systemic imbalance, Daleron contributes to easing the overall symptom load, and may support the patient during difficult episodes by easing distress.

Quick Fact: Relief for Pain Quick Fact: Relief for Fever
Symptom Scope: Mild to moderate acute pain, including headache and toothache.
Symptom Scope: Elevated body temperature (pyrexia) associated with infections.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who can and cannot use Daleron (Acetaminophen)?

Official eligibility for Daleron (Acetaminophen/Paracetamol) is defined by regulatory bodies based on population characteristics and clinical status.

Eligibility Status Officially Documented Groups
Contraindicated Use Patients with a known hypersensitivity to the active substance or excipients. Use is strictly prohibited for individuals with severe hepatic impairment or severe active liver disease.
Conditional Use (Caution) Individuals with severe renal impairment (creatinine clearance leq 30 mL/ min), chronic alcoholism, chronic malnutrition, or mild to moderate hepatic impairment. These populations require cautious use and often a restriction of the total daily dose, as defined by regulatory labeling.
Generally Permitted Adults, adolescents, and older adults. Pediatric eligibility is based on age and weight, and is dependent on the specific product formulation.

Special Population Eligibility

Regulatory documents classify use during pregnancy and lactation as generally permitted when clinically necessary. Use is defined by the requirement to utilize the lowest effective dose for the shortest possible duration. No routine dose adjustment is specified for the geriatric population in the absence of underlying organ dysfunction. Certain high-strength oral solid forms are typically not recommended for young children below specified age or weight thresholds due to formulation unsuitability.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation establishes that Acetaminophen (the active ingredient in Daleron) interacts with certain medicines and substances primarily by modifying its metabolism or clearance, or by enhancing the effects of co-administered agents. The regulatory labeling strictly prohibits co-administration with any other product containing Acetaminophen to mitigate the documented risk of severe hepatotoxicity.

Documented Interaction Patterns

Interaction Type Interacting Agent Examples Official Outcome Description
Metabolic/Clearance Phenytoin, Rifampicine, Chronic Alcohol Use Accelerated formation of toxic metabolites, increasing hepatotoxicity risk.
Probenecid, Isoniazid Documented reduction in Paracetamol clearance.
Pharmacodynamic Vitamin K Antagonists (e.g., Warfarin) Enhanced anticoagulant effect with prolonged, regular use.
Zidovudine Increased risk of neutropenia.
Absorption Rate Metoclopramide, Domperidone Increase the absorption rate, leading to faster peak levels.
Cholestyramine Reduces the absorption, requiring a mandatory timing separation (administer at least 1 hour before or 4 hours after).

These interactions are formally classified in regulatory documents, with special consideration for populations such as those with chronic alcoholism, where the severity of hepatotoxicity risk is officially greater.

Mechanism of Action

Central Modulation of Nociceptive Signaling via COX and Cannabinoids

The pharmacological activity is primarily confined to the Central Nervous System (CNS), where Acetaminophen acts through two complementary mechanisms. The molecule selectively inhibits the Cyclooxygenase-2 ( COX-2) enzyme under conditions of low peroxide concentration, reducing the synthesis of prostaglandin E2 ( PGE2) that contributes to neuronal sensitization. Concurrently, its metabolite, AM404, indirectly engages the Endocannabinoid System by inhibiting the reuptake of Anandamide (AEA). This dual activity within the CNS increases the threshold for nociceptive signal transmission.


Targeted Resetting of the Hypothalamic Thermoregulator

The antipyretic mechanism is localized to the Hypothalamus, the central thermoregulation site. Inhibition of PGE2 synthesis here functionally resets the thermoregulatory set point that has been elevated during pyrexia. This adjustment triggers systemic heat-dissipation mechanisms, including peripheral vasodilation and increased sweating, leading to physiological heat loss from the core.


Mechanistic Constraints in Peripheral Inflammation

The mechanism of COX inhibition is significantly attenuated in the high peroxide environment characteristic of peripheral inflammatory sites. Consequently, while active in modulating central signaling, the mechanism does not suppress the generation of inflammatory mediators in the periphery.

Dosage and Administration Information

How to Use Daleron (Acetaminophen)

Acetaminophen, the active substance in Daleron, is administered via multiple routes. These include oral (tablets, capsules, solutions), rectal (suppositories), and intravenous (IV) (injectable solution) administration. The chosen route often depends on the clinical context and the patient's ability to swallow.


Standard Dosing Regimens and Frequency

Standard adult dosing for immediate-release oral and rectal forms ranges from 325 mg to 1,000 mg per single dose. This is typically taken every 4 to 6 hours as needed (PRN), according to an intermittent-use pattern. A critical principle in administration is adherence to the strict maximum total daily dose, which must not exceed 4,000 mg (4 grams) from all combined sources over a 24-hour period. Extended-release oral formulations are administered less frequently, typically every 8 hours.


Administration Conditions and Adjustments

Oral Acetaminophen may be taken with or without food. For specialized forms, specific procedural rules apply: intravenous solutions must be administered as an infusion over 15 minutes, and extended-release tablets must be swallowed whole and not crushed.

Dosage adjustments are required for specific patient groups. Pediatric patients require weight-based dosing, generally 10 to 15 mg/kg per dose. For adults with severe renal impairment, the minimum interval between doses is extended, often to every 6 or 8 hours, to account for altered clearance.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Daleron (Acetaminophen)

This section provides an overview of the types of research conducted on Daleron (Acetaminophen) and describes the findings in a neutral, non-causal manner, highlighting what the studies observed and where the evidence remains limited, without providing clinical advice or treatment recommendations.


Evidence for Use in Managing Acute Pain

Numerous short-term Randomized Controlled Trials (RCTs) and Systematic Reviews have been used in research exploring how symptoms change over time in cohorts that have been studied for outcomes related to acute pain. These studies examined outcomes related to physical discomfort and outcomes reflecting daily functioning in populations with conditions associated with acute or disruptive episodes, such as tension headaches or pain following minor surgery. Findings describe patterns observed in these studies related to short-term changes in pain intensity when compared to a control substance.

What remains uncertain is the full picture of outcomes related to different standard single doses; comparative evidence is lacking for certain dose measurements in general acute settings. Furthermore, follow-up durations were limited in most primary research, meaning there is limited information for long-term outcomes related to repeated use over extended periods.


Evidence for Use in Managing Elevated Body Temperature (Fever)

The research into Daleron (Acetaminophen) for outcomes related to elevated body temperature primarily involves Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies were studied for outcomes related to systemic or functional imbalance, with the central measured outcome being the change in body temperature and the incidence of fever.

Data show patterns related to symptom changes typically observed within the short-term, acute phase in cohorts of Adults, Children, and Infants. Data for certain groups remain insufficient when looking at specific, severely ill patient populations, such as those in critical care settings with severe infections. Certainty remains low for some of these highly specific scenarios due to a lack of high-quality data.


Evidence in Special Patient Populations

Research has explored the use of the medicine in several special groups. The evidence base includes multiple studies for Pediatric patients, with research exploring short-term symptom changes related to fever and pain. Separate studies, often Randomized Controlled Trials, were observed in cohorts of Infants to examine measured outcomes following the administration of the medicine in the context of post-vaccination fever. However, some of these studies reported measured differences in immune responses to certain vaccines, and research on the clinical impact of these observations remains uncertain.

Older Adults are represented within the broader acute pain studies, and regulatory reviews have often noted that data show patterns related to measured outcomes comparable to younger adult groups. Observational research was observed in women during pregnancy; however, findings related to potential long-term neurodevelopmental outcomes varied across studies.

Key Studies & References

  1. IV Acetaminophen for Acute Pain in Emergency Departments (NCBI Bookshelf/NIH)
  2. Study reveals no causal link between neurodevelopmental disorders and acetaminophen exposure before birth (NIH News Release on sibling study)

Frequently Asked Questions (FAQ)

Common questions about Daleron (Acetaminophen) (FAQ)

Q: What is the difference between Daleron and other common over-the-counter pain relievers, like ibuprofen or aspirin?

Acetaminophen, the active ingredient in Daleron, is classified as a non-opioid pain reliever and fever reducer (antipyretic). Official pharmacological information indicates that its primary action is within the Central Nervous System (the brain and spinal cord) to modulate pain signals. This mechanism is different from drugs like ibuprofen and aspirin, which belong to the class of NSAIDs and act more broadly in the body to reduce inflammation.

Q: Can Daleron treat pain that is caused by inflammation?

Regulatory documents describing the mechanism of action indicate that acetaminophen does not suppress inflammatory processes. The action is limited in areas of peripheral inflammation, which are characterized by high levels of peroxides. This is consistent with Daleron's core classification as an analgesic and antipyretic, focusing on pain and fever relief rather than directly reducing swelling or inflammation.

Q: How quickly should I expect Daleron to start working?

According to the official product information on pharmacokinetics, when Daleron is taken orally, the active ingredient is rapidly absorbed. Peak concentrations in the bloodstream are typically reached within a window of 30 to 60 minutes after administration.

Q: How long does the pain-relieving effect of one dose of Daleron typically last?

Regulatory guidance for standard immediate-release formulations specifies that a dose may be administered every 4 to 6 hours, as needed. This interval is set to align with the expected duration of action and effect of a single dose.

Q: What should I do if Daleron does not seem to be relieving my pain or fever?

Official product labeling generally directs that if pain or fever worsens while taking the medicine, use should be stopped. It is important to seek consultation with a healthcare professional if symptoms persist beyond the time frames specified on the product label.

Q: Are there any long-term side effects associated with taking Daleron regularly?

Official regulatory reviews of the research indicate that the evidence base from clinical trials primarily focuses on short-term use of the medicine. Due to limited follow-up durations in most primary research, there is limited information available regarding long-term outcomes related to repeated use over extended periods.

Q: Is it possible to have an allergic reaction to Daleron?

Regulatory documentation lists known hypersensitivity to the active substance (acetaminophen) or excipients as a contraindication. Hypersensitivity is the clinical term for an allergic reaction, and the risk of severe, potentially fatal reactions is acknowledged in official safety documents.

Q: What are the signs of liver damage related to Daleron use?

Regulatory documents and overdose information explicitly describe the signs of potential liver injury (hepatotoxicity). These signs can include yellowing of the skin or eyes (jaundice), dark urine, pain in the upper right abdomen, nausea, vomiting, and loss of appetite.

Q: What types of over-the-counter medicines commonly contain the same active ingredient as Daleron?

Official safety campaigns advise consumers that acetaminophen is an active ingredient in many combination medicines, particularly those marketed for the symptoms of cold, flu, and allergies. To prevent exceeding the maximum daily limit, careful checking of product labels for all medicines taken concurrently is necessary.

Q: Is Daleron safe for use by pregnant women?

Official regulatory documents classify use during pregnancy as generally permitted when it is clinically necessary. The regulatory advice specifies utilizing the lowest effective dose for the shortest possible duration.

Q: Does Daleron affect the efficacy of oral contraceptives or birth control?

Research has examined the interaction between acetaminophen and components found in some oral contraceptives. Studies suggest that certain components may increase the metabolism of acetaminophen, but concurrent administration at usual therapeutic doses generally results in no significant additional risk to the efficacy of either medicine.

Q: What are the general recommendations for how long a person can continuously use Daleron for pain or fever?

Regulatory labeling for over-the-counter use provides time limits for self-medication without professional consultation. If symptoms require continuous use exceeding 3 days for fever or 10 days for pain in adults, consulting a healthcare professional is consistent with regulatory guidance.

Q: Why is it important to check labels for the abbreviation 'APAP' or 'acetamin'?

Public health safety campaigns emphasize the need to check medicine labels for all forms and abbreviations of the active ingredient. Acetaminophen may be listed as 'APAP' or 'acetam,' and identifying these terms supports the prevention of accidental double-dosing when taking multiple products containing the same ingredient.

Q: Can I take Daleron if I have a condition like G6PD deficiency or PKU?

For patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency, official guidance recommends that cautionary measures be discussed with a healthcare professional. This is due to a potential risk of hemolytic anemia (a blood disorder).

Q: Is it necessary to avoid certain foods or drinks while using Daleron?

Regulatory guidance on administration states that the medicine can be taken with or without food. However, product labeling directs that alcohol consumption should be limited or avoided due to the increased risk of liver damage.

Q: What does research indicate about the effectiveness of Daleron for chronic pain conditions?

Research studies primarily focus on the management of acute (short-term) pain and fever. Official regulatory reviews note that comparative evidence is limited regarding outcomes related to long-term use in chronic pain settings.

Q: Is there a risk of rebound headaches from using Daleron frequently?

Frequent or excessive use of simple pain relievers, including acetaminophen, over a period of several months is associated with the risk of developing medication overuse headaches. This condition is a recognized adverse consequence of using these types of medicines too often.

Q: How is Daleron cleared from the body?

Official pharmacokinetic information indicates that acetaminophen is primarily cleared from the body through a process called metabolism that takes place in the liver. Most of the resulting breakdown products (metabolites) are then subsequently excreted from the body via the urine.

Q: Is Daleron safe for people who have asthma or breathing problems?

Regulatory documents do not list asthma or general breathing problems as a formal contraindication for acetaminophen. However, it is noted that caution should be exercised by individuals who have a history of severe allergies or breathing difficulties.

Q: Can Daleron be taken at the same time as a sleep aid?

To prevent accidental overdose, it is necessary to confirm that any co-administered sleep aid does not already contain acetaminophen. If the sleep aid contains a different active ingredient, consultation with a healthcare professional is recommended to assess potential drug-drug interactions.

Q: Is there any difference in effect between brand-name Daleron and a generic acetaminophen product?

Regulatory agencies approve generic acetaminophen products only if they demonstrate bioequivalence to the brand-name product. This means the products must contain the same active ingredient, strength, and dosage form, and are expected to have the same effect in the body.

Q: What are the signs that a person might be having an unusual reaction to Daleron?

Official safety warnings describe signs that indicate a potentially severe or unusual reaction. These signs can include difficulty breathing, the development of hives, swelling of the face, lips, throat or tongue, or the appearance of blisters or peeling skin.

Q: Does the time of day matter when taking Daleron?

Official regulatory guidance focuses on ensuring the correct interval between doses is maintained, which is typically 4 to 6 hours for immediate-release formulations. The guidance does not mandate a specific time of day for administration.

How should Daleron (Acetaminophen) be stored and disposed of?

Storage and Disposal Requirements for Acetaminophen

Acetaminophen products must be stored under Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F), and protected from moisture and excessive heat. Liquid and injectable forms may require protection from light, and the injectable solution is specifically instructed not to be refrigerated or frozen. All forms must be stored out of the sight and reach of children to prevent accidental overdose.

Official Disposal Guidance

Do not use the medicine past its expiration date. Unused or expired medication should be disposed of via Drug Take-Back Programs when available. If not, dispose of the medicine in household trash after mixing it with an undesirable substance, such as coffee grounds, and sealing the mixture in a container.

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

Available in countries:

Equivalent of Daleron (Acetaminophen) found in:

A-Z Index: