Paceco

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Paceco

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Medically reviewed

Laura Arias

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 Paceco

Property Description
Active ingredients Acetaminophen (Paracetamol), Codeine
Form Tablet, Caplet, Capsule, Liquid
Pharmacological class Opioid Analgesic and Non-Opioid Analgesic Combination
Common use Enhanced management of pain and fever
Origin Synthetic and Semi-synthetic

Composition and Form: Ingredients and Origin

Paceco is a prescription-only combination medication defined by the presence of two active agents: Acetaminophen (Paracetamol) and Codeine, often presented as Codeine Phosphate. The formulation utilizes substances of mixed origin: Acetaminophen is an entirely synthetic compound, while Codeine is categorized as semi-synthetic, derived from natural opioid alkaloids. This combination is clinically recognized for its effectiveness in oral administration, typically supplied as a Tablet, Caplet, or Capsule, or a Liquid solution. Popular pharmaceutical preparations containing this specific ingredient combination include Tylenol-Codeine #3 and Empracet.

Paceco's General Therapeutic Purpose

The primary purpose of Paceco is to provide enhanced symptomatic management of discomfort, particularly when mild to moderate pain is accompanied by fever. As an Opioid Analgesic and Non-Opioid Analgesic Combination, the drug employs a dual mechanism to achieve comprehensive relief. The Codeine component addresses pain by modulating signals in the central nervous system, and the Acetaminophen component inhibits pain pathways while delivering a critical antipyretic action (fever reduction). The combination of these agents offers more substantial symptomatic relief than either component alone. The formulation’s unique strength lies in its ability to address different components of patient discomfort simultaneously.

Regulatory References

  1. WHO Model Lists of Essential Medicines

What side effects are possible with Paceco?

Adverse Reaction Scope

The medicine's safety profile is documented primarily by adverse reactions affecting the Nervous System and Gastrointestinal Disorders. Reactions such as drowsiness, lightheadedness, dizziness, nausea, and constipation are classified as frequently reported or common in regulatory documents.


Serious Adverse Reactions

The official labeling documents two major, life-threatening safety risks. The opioid component (Codeine) carries a risk of life-threatening respiratory depression, which can be fatal. This risk is greatest during the initiation of therapy or following a dosage increase. The non-opioid component (Acetaminophen) is associated with the potential for acute liver failure and hepatotoxicity, particularly with use exceeding the recommended daily limits or with prolonged high-dose use. Rare but serious skin reactions, including Stevens-Johnson Syndrome (SJS), have also been reported with acetaminophen use.


Population-Specific Safety Considerations and Restrictions

Official regulatory bodies impose several strict constraints on use for specific groups:

  • Pediatric Patients: The medication is contraindicated for use in children younger than 12 years of age and in adolescents younger than 18 years of age following tonsillectomy or adenoidectomy due to the risk of severe respiratory problems.
  • Ultra-Rapid Metabolizers: It is contraindicated in patients of any age who are known to be ultra-rapid metabolizers of codeine.
  • Breastfeeding Mothers: Breastfeeding is not recommended during treatment due to the risk of serious adverse reactions, including excessive sedation and respiratory depression in the infant.
  • CNS Depressants: Concomitant use with alcohol and other CNS depressants is documented to increase the risk of profound sedation, respiratory depression, and death.

The official label also notes that repeated administration of the codeine component may lead to physical dependence and addiction.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory information emphasizes the dual risk of toxicity from Paceco's two active components, Acetaminophen and Codeine, requiring specific emergency responses. Immediate medical attention must be sought for any suspected overdose, even if initial symptoms are absent, as clinical evidence of severe toxicity may be delayed for 48 to 72 hours [Source: NIH MedlinePlus].


Documented Manifestations and Outcomes

Component Early Symptoms and Signs Severe/Life-Threatening Outcomes
Acetaminophen Nausea, vomiting, pallor, malaise Fatal hepatic necrosis, acute renal failure
Codeine Respiratory depression, somnolence, constricted pupils (miosis) Respiratory arrest, circulatory collapse

Regulator-Mandated Emergency Actions

The overdose profile is defined as potentially severe or life-threatening by regulatory bodies. Treatment protocols are based on the component causing toxicity. Acetylcysteine is the specific antidote for Acetaminophen poisoning, while Naloxone is the specific opioid antagonist used to reverse Codeine-induced respiratory depression [Source: FDA Labeling]. Supportive measures, including establishing a patent airway, providing assisted ventilation, and performing gastric decontamination with activated charcoal, are officially described procedures. Monitoring of serum Acetaminophen levels and hepatic function tests is required to guide intervention and observe for delayed toxicity.

Therapeutic Uses of Paceco

What Paceco Treats: Main Uses and Benefits

Paceco is commonly used to help with symptoms related to physical discomfort and systemic imbalance, applying across domains where additional symptomatic support is needed. This medication is used to relieve pain, while its acetaminophen component is also considered relevant for easing fever.

This combination is primarily used to address two central symptom clusters: mild to moderate pain and fever. It is relevant in conditions characterized by periods of heightened symptoms, such as acute pain episodes, discomfort following minor procedures, or ongoing support in palliative care. The combination generally offers symptomatic relief that helps patients cope more steadily with difficult episodes.

“This medication is considered relevant for easing discomfort in situations when additional management of discomfort is required.”

Relief of Mild to Moderate Pain

This domain focuses on discomfort that creates noticeable physiological strain. It provides support that helps ease the overall symptom burden in situations where single-agent pain relievers may not be appropriate.


Quick Fact: Therapeutic Domains

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

The eligibility for Paceco (Acetaminophen and Codeine combination) is strictly defined by regulatory authorities to limit use based on specific patient characteristics and underlying conditions. The most definitive restrictions relate to age, genetic factors, and physiological status.

Contraindicated Populations Rationale (Official Regulatory Status)
Children younger than 12 years Contraindicated due to risk of serious and life-threatening respiratory depression.
Breastfeeding women Contraindicated; Codeine metabolites pass into breast milk, posing a risk of toxicity to the infant.
CYP2D6 Ultra-Rapid Metabolizers Contraindicated due to rapid conversion of Codeine to high, toxic levels of morphine.
Severe Respiratory Depression Contraindicated in acute or severe bronchial asthma or significant respiratory depression.
Post-Tonsillectomy/Adenoidectomy Contraindicated in pediatric patients (under 18 years) for post-operative pain management following these surgeries.

Restricted or Conditional Use is required for older adults, who are more susceptible to the drug's effects, and patients with severe hepatic or renal impairment, where drug clearance is compromised. The use during pregnancy is generally not recommended, particularly prolonged use in the third trimester, due to the risk of Neonatal Opioid Withdrawal Syndrome.

What should I know about interactions with other medicines?

Paceco Interactions with other medicines and products

Clinical experience and regulatory documentation indicate that Paceco (an analgesic antipyretic derivative of acetanilide, which may be referenced as a historical name for a compound similar to acetaminophen or paracetamol, or a related complex) has the potential for pharmacokinetic and pharmacodynamic interactions.

Officially documented interactions highlight the need for careful management when Paceco is used concurrently with specific drug classes or substances that alter drug metabolism.

Interacting Medicinal Products and Substances

Category/Class Documented Interaction Profile
Hepatotoxic Agents Agents that cause or contribute to liver toxicity. Concomitant use increases the overall risk of hepatotoxicity.
Warfarin (Oral Anticoagulants) May potentiate the effects of anticoagulants, increasing the risk of bleeding complications. This is a clinically significant interaction.
Enzyme Inducers Medicines that accelerate the metabolism of other drugs in the liver. These may increase the rate at which the Paceco component is broken down, potentially reducing its therapeutic effect or increasing toxic metabolite formation.
Alcohol Concomitant consumption significantly increases the risk of serious liver damage due to additive hepatotoxicity.

Interaction Mechanism Summary

The primary concern for known interactions relates to the potential for hepatic enzyme effects (metabolism) and pharmacodynamic synergy (additive toxicity). The use of Paceco with other hepatotoxic medicines places an increased burden on the liver, raising the risk of severe hepatic injury and requiring close monitoring, particularly in patients with pre-existing liver impairment. The interaction with Warfarin is based on affecting the metabolism of the anticoagulant, thereby enhancing its blood-thinning effects.

Mechanism of Action

Modulating Pain Signaling via Central Opioid Receptors

This mechanism involves the Codeine component, which, after being converted into its active metabolite, acts as an agonist on mu-opioid receptors ( MOR) within the brain and spinal cord. The activation of these G-protein coupled receptors inhibits the release of key neurotransmitters, thereby inhibiting the transmission of nociceptive signals in the ascending pathway.


Resetting the Hypothalamic Thermostat and Antipyresis

The Acetaminophen component primarily operates by inhibiting Cyclooxygenase ( COX) activity that is specific to the Central Nervous System ( CNS). This inhibition curtails the synthesis of PGE2 in the hypothalamus, the molecule responsible for elevating the core body temperature set point. This mechanistic action resets the core body temperature set point.


Multimodal Synergy Across Nociceptive Pathways

The dual action provides complementary modulation by combining the opioid-receptor mechanism with Acetaminophen's diverse central mechanisms, including COX inhibition and the modulation of central pain systems through TRPV1 and CB1 receptors. This combination supports multimodal suppression of nociceptive signaling by inhibiting ascending signals while simultaneously activating descending inhibitory pathways.

Dosage and Administration Information

How Paceco is Used: Official Administration Guidelines

Paceco is exclusively administered via the oral route, utilizing dosage forms such as tablets, capsules, and liquid solutions. The overall procedural structure for proper use is defined by quantity, timing, and duration constraints.

Dosing and Frequency

The standard dose for adults is typically one to two dosage units taken as needed. A new dose must not be repeated more frequently than the minimum required interval, which is generally every 4 hours to every 6 hours, depending on the specific formulation strength and regional labeling. Liquid formulations require the suspension to be shaken well and measured with a specialized device prior to ingestion.

Maximum Limits and Duration

A key constraint is the strict limit on the Acetaminophen component: the total daily intake from all sources must not exceed 4,000 mg (4 grams) within a 24-hour period. Therefore, patients must strictly avoid taking any other product containing Acetaminophen concurrently. The medication should be used for the shortest duration necessary for effective management. In several jurisdictions, continuous use is explicitly limited to a maximum of three days without professional re-evaluation.

Population-Specific Rules

Specific rules govern use in certain populations: the medication is not recommended for children under 12 years of age. For older adults and patients with impaired kidney function, dosage selection should be cautious, often requiring the use of the lowest effective dosage and potentially extending the interval between administrations.

Recent Clinical Evidence

Research evidence / Overview of studies for Paceco

Overview of Studies for Paceco: Research Landscape

The clinical evaluation for the Acetaminophen and Codeine combination relies primarily on Randomized Controlled Trials (RCTs). This type of research is considered the foundation for understanding how a medication compares to an inactive substance (placebo) or a single active component. RCTs for this combination are used in research exploring how symptoms change over time. Additionally, Systematic Reviews and Meta-Analyses are relevant in evidence describing how symptoms are measured, as they pool findings from many individual trials to assess consistency and patterns across different research settings. The evidence derived from these settings often focuses on outcomes related to physical discomfort.


Evidence for Use in Managing Acute, Mild to Moderate Pain

The core evidence for this combination was evaluated in studies focusing on episodes where symptoms require management, particularly in conditions associated with acute or disruptive episodes. This medication was evaluated in research exploring populations of adults experiencing temporary discomfort, such as following dental procedures or minor surgeries.

In these studies conducted during periods of increased symptom activity, researchers measured outcomes related to physical discomfort, such as pain intensity and patient-reported outcomes describing perceived discomfort. Research highlights changes measured during the study period, with findings describing patterns observed in the studies that varied when comparing the combination to both placebo and the single Acetaminophen component over short observation intervals. Research provides context but not individual predictions, and studies report how symptoms evolved in the observed populations during the hours immediately following administration.


Evidence for Symptomatic Fever Reduction

The evidence base related to outcomes linked to inflammatory or irritative states, such as the management of elevated body temperature, is predominantly driven by the established research on the Acetaminophen (Paracetamol) component of the combination. Research has examined the medication's effect on elevated body temperature, which is an outcome reflecting systemic or functional imbalance. Changes in elevated temperatures measured during the study period were described as short-term, typically lasting several hours.


Limitations and Uncertainties in the Research Base

Clinical trials for the combination primarily consist of short-term studies; observation periods focus on short-term or episodic symptom patterns, often extending only for a few hours after a single dose. Consequently, there is limited information for long-term outcomes or durability of response. One key limitation is the known variability in patient response to the Codeine component, which research describes as linked to factors that affect how individuals process the drug. Comparative evidence against a wide range of other available analgesics is also limited. The results apply only to the populations studied, and certainty remains low regarding outcomes outside of acute episodes.

Key Studies & References

  1. TYLENOL WITH CODEINE- acetaminophen and codeine phosphate tablet (FDA Prescribing Information/DailyMed)
  2. Codeine for Acute Extremity Pain
  3. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for Codeine Therapy in the Context of Cytochrome P450 2D6 (CYP2D6) Genotype
  4. WHO Model List of Essential Medicines

Frequently Asked Questions (FAQ)

Common questions about Paceco (FAQ)


Q: How quickly should I expect Paceco to start having an effect?

Official product information, based on pharmacological studies, indicates that the pain-relieving effects typically reach their peak within approximately 2 hours after the medication is administered. Individual responses to medications, however, may vary.

Q: Can Paceco cause long-term health issues?

Regulatory documents describe that the medication is intended for use for the shortest possible duration due to the potential for risks like addiction, abuse, and dependence. The Acetaminophen component carries a specific and serious risk of liver failure if the maximum recommended dose limits are exceeded.

Q: Does Paceco affect sleep patterns?

The Codeine component is classified as a central nervous system (CNS) depressant. Official documents describe that the medication can cause side effects such as drowsiness, sedation, and tiredness, which are factors that may influence sleep patterns.

Q: Is it common to feel tired when taking Paceco?

Yes, official regulatory documents list fatigue, drowsiness, dizziness, and lightheadedness as frequently reported adverse reactions. These effects are related to the way the medication acts on the central nervous system.

Q: Can Paceco interact with common over-the-counter pain relievers?

The most critical regulatory warning is that concomitant use with any other product containing Acetaminophen is strongly discouraged, as this practice may lead to exceeding the daily limit and potentially cause severe liver injury. Official warnings also provide general cautions about combining Paceco with other pain relievers.

Q: Are there any specific foods or drinks to avoid while taking Paceco?

Official warnings specifically caution against the concurrent use of alcohol with this medication. Combining alcohol with the opioid component greatly increases the risk of profound sedation, respiratory depression (severe difficulty breathing), coma, and death.

Q: What happens if I stop taking Paceco suddenly?

If physical dependence on the opioid component has occurred, regulatory documents warn that abruptly discontinuing the medication may result in serious withdrawal symptoms. The medication is intended for use only for the duration necessary to manage pain, according to official guidance.

Q: Can young adults use Paceco?

Official guidance typically contraindicates, or does not recommend, this medication for children under 12 years of age. Furthermore, specific warnings discourage its use in certain adolescents aged 12 to 18 who may have particular risk factors for breathing problems.

Q: Does Paceco require regular blood tests or monitoring?

While regulatory documents do not mandate routine blood tests for all users, monitoring for signs of respiratory difficulty, liver injury, and potential addiction is generally described as necessary. The medication is also known to potentially affect levels of sex hormones.

Q: Is there a generic version of Paceco available?

Regulatory records from agencies like the FDA indicate that generic versions of the combination product (Acetaminophen and Codeine) have been approved and are available on the market.

Q: How long can a person safely stay on Paceco?

Official regulatory guidance emphasizes that the medication is intended for the shortest duration possible. Some specific regional documents explicitly limit continuous use to a maximum of three days without further medical evaluation due to the risk of dependence.

Q: Does Paceco affect fertility or reproductive health?

Official adverse reaction reports note that the prolonged use of the opioid component may be associated with decreased levels of sex hormones. This can potentially lead to issues such as low libido, erectile dysfunction, and potential infertility in both males and females.

Q: Can Paceco interact with herbal supplements?

Official documents warn that the Codeine component is processed by specific liver enzymes (CYP450). Interactions can occur with substances, including some herbal supplements, that either increase or decrease the activity of these enzymes.

Q: Why do some people say Paceco didn't work for them?

Official documents describe factors that can influence effectiveness. These include developing a tolerance to the pain-relieving effects over time, or having a genetic profile (ultra-rapid metabolism) that prevents the body from adequately converting Codeine into its active form.

Q: Is Paceco approved for treating conditions other than the main one listed?

Official indications state that the primary approved use is for the relief of mild to moderately severe pain. The Codeine component of the medication is also noted in regulatory documents for potentially having cough-suppressing (antitussive) properties.

Q: How long does Paceco stay in your system?

Pharmacokinetic data shows that the Codeine component has a plasma half-life of approximately 2.9 hours, and Acetaminophen's half-life is between 1.25 and 3 hours. Most of both components are eliminated from the body within 24 hours.

Q: Are headaches a common side effect of Paceco?

Yes, headache is listed in official regulatory documents as one of the potential side effects that may occur with the use of this medication.

Q: Can Paceco interact with birth control pills?

Official warnings advise caution when combining Paceco with drugs that affect certain liver enzymes (CYP450), which process the Codeine component. Some hormonal contraceptives may be metabolized through these same enzyme pathways.

Q: Is it possible to be allergic to Paceco?

Official contraindications state that the medication must not be given to patients who have previously shown signs of hypersensitivity or an allergic-type reaction to either Codeine or Acetaminophen.

Q: Does Paceco affect your ability to drive or operate machinery?

Official warnings state that this medication may impair the mental and physical abilities needed for tasks like driving or operating machinery. Caution related to operating machinery may be warranted until the individual is tolerant to the medication's effects.

Q: Is Paceco safe for people with liver disease?

Official warnings indicate that caution is generally necessary for individuals with existing impairment of hepatic function, as the risk of acute liver failure from the Acetaminophen component is increased.

Q: Can Paceco be taken during pregnancy?

Official regulatory documents categorize the medication for use in pregnancy, stating it should be used only if the potential benefit justifies the potential risk. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome in newborns.

Q: What are the serious but less common side effects of Paceco?

Serious potential effects described in official warnings include life-threatening respiratory depression (severe breathing problems), acute liver failure from the Acetaminophen component, and rare severe skin reactions or hypersensitivity.

Q: Why is Paceco only available by prescription?

Paceco contains Codeine, which is classified as a controlled, scheduled substance by regulatory bodies (e.g., CIII in the US). It requires a prescription due to the associated risks of addiction, abuse, and misuse.

Q: Is it possible for Paceco to stop working over time?

Yes, regulatory documents note that continuous or repeated use of the opioid component may lead to the development of analgesic tolerance. This means that the body may require higher concentrations of the medication to achieve the same pain-relieving effect over time.

Q: Can Paceco affect your mood or mental state?

The opioid component acts on the central nervous system. Official adverse reaction lists include potential effects on the mental state, such as confusion, mood changes, and other psychiatric disturbances.

Q: Is Paceco safe for people who have heart conditions?

Official documents describe that the opioid component can cause peripheral vasodilation, which means blood vessels widen. This effect can lead to orthostatic hypotension (a drop in blood pressure when moving from sitting or lying to standing).

Q: Are there any common reasons people are told not to use Paceco?

Common reasons are listed in official contraindications, including known hypersensitivity or allergy to either Codeine or Acetaminophen, the presence of severe breathing problems or asthma, and, typically, use in children under 12 years of age.

Q: Does Paceco cause changes in blood pressure?

Official adverse reaction reports indicate that the opioid component can cause orthostatic hypotension. This effect is a drop in blood pressure that occurs when an individual changes their position too quickly.

How should Paceco be stored and disposed of?

How to Store and Dispose of Paceco

Official regulatory guidelines require that Paceco (Acetaminophen and Codeine) be stored under specific environmental controls, primarily due to its combination of active ingredients and the potential for misuse.

Storage Requirement Official Condition
Temperature & Protection Store at Controlled Room Temperature (20°C to 25°C) and keep away from excessive heat, moisture, and freezing.
Packaging Keep the medication in its original container, tightly closed.
Child Safety The product must be kept out of the sight and reach of children and stored in a secure location.

For disposal, unused or expired Paceco must be safely discarded to prevent accidental exposure or misuse. The preferred method is to use an authorized drug take-back program. If a take-back program is unavailable, unused medication should be mixed with an unappealing substance (like coffee grounds or dirt) and sealed in a container before being placed in the household trash. This product should generally not be flushed down the toilet.

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

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