Ultracod

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Ultracod

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Ultracod

Property Description
Active Ingredients Acetaminophen, Codeine
Form Oral Tablet (Fixed-Dose Combination)
Pharmacological Class Combined Opioid Analgesic
Common Use Pain Relief (Analgesia)
Origin Semi-Synthetic

What Type of Medicine is Ultracod?

Ultracod is a fixed-dose combination (FDC) preparation classified pharmacologically as a combined opioid analgesic. This designation confirms it is a pharmaceutical entity that pairs two distinct pain-relieving agents in a single formulation, distinguishing it from single-ingredient medicines. The product is provided as a solid-dose tablet designed for straightforward oral administration. The Codeine/Acetaminophen combination is used for pain, as its dual mechanism provides additive relief. This combination is clinically recognized for providing enhanced relief compared to the non-opioid component alone, a factor that differentiates it from general analgesic options available over the counter.


Composition and Dual Analgesic Components

The unique efficacy of Ultracod is based on its two active ingredients: Acetaminophen (a non-opioid analgesic and antipyretic) and Codeine (specifically Codeine phosphate), a semi-synthetic opioid alkaloid. This specific formulation is broadly known by the generic term Co-codamol in various regions, with equivalent products including Tylenol with Codeine and certain Paracetamol/Codeine preparations. The preparation's chemical nature is defined by this blend, combining the synthetic origin of Acetaminophen with the Codeine component, which is chemically derived from the natural opium alkaloid Morphine. Fixed combinations of Codeine and non-opioids like Acetaminophen are established for providing analgesia. This confirms that the formulation is a medically recognized and established approach for pain management.


General Therapeutic Purpose

The fundamental purpose of Ultracod is to provide effective analgesia by leveraging the synergistic components. The preparation is designed to manage discomfort, such as pain following a dental procedure or injury, by simultaneously modulating the central perception of pain through the opioid component and influencing the body's general response to pain and fever via the non-opioid component. This intentional co-formulation delivers a dual therapeutic action that results in an elevated pain tolerance threshold, enhancing the potential for reliable pain relief.

Regulatory References

  1. MedlinePlus Drug Information on Acetaminophen and Codeine
  2. EMA review of codeine-containing medicines
  3. EMA Codeine-containing medicines referral

What side effects are possible with Ultracod?

Possible Side Effects and Safety Information

The official regulatory safety documentation for the Codeine/Acetaminophen combination (Ultracod) details potential patient experiences organized by frequency and the physiological system affected.

Commonly Documented Adverse Reactions

The most frequently reported adverse reactions in official prescribing information primarily affect the nervous and gastrointestinal systems. These include drowsiness, lightheadedness, dizziness, and sedation. Gastrointestinal effects commonly observed are nausea, vomiting, and constipation. These effects may be more prominent in ambulatory than in non-ambulatory patients.

System-Organ Class (SOC) Examples of Documented Effects
Nervous System Dizziness, sedation, drowsiness, lightheadedness
Gastrointestinal Nausea, vomiting, constipation, abdominal pain
Skin Pruritus (itching), rash

Serious Adverse Reactions and Safety Constraints

Official government sources emphasize the potential for serious adverse reactions. The Acetaminophen component carries a documented risk of Hepatotoxicity, potentially leading to acute liver failure. The Codeine component is associated with the risk of Life-Threatening Respiratory Depression, which is highest during the initiation of therapy or following a dose increase. This product carries the risk designation for opioid addiction, abuse, and misuse.

Population-Specific Constraints: The medicine is contraindicated in children younger than 12 years of age and in pediatric patients younger than 18 years following tonsillectomy or adenoidectomy. Caution is advised for use in older adults and individuals with hepatic or renal impairment.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Ultracod involves the documented toxicological risks associated with its two active components: Acetaminophen and Codeine. Severe outcomes include Acute Liver Failure (ALF) and Life-Threatening Respiratory Depression.

Category Official Regulatory Statement or Entity
Documented Overdose Presentations Initial signs may include nausea, vomiting, loss of appetite, and abdominal pain (Acetaminophen); CNS symptoms may include profound sedation, stupor, pinpoint pupils (miosis), and convulsions (Codeine).
Physiological Systems Affected Hepatic system (leading to liver damage/failure); Central Nervous System (CNS); Respiratory system (leading to apnea); Circulatory system.
Population-Specific Notes The risk of severe hepatotoxicity is increased in patients with chronic hepatic disease. Children under 12 and elderly/debilitated patients have an increased risk for life-threatening respiratory depression.
Mandated Emergency Action Seek medical help right away. Contact Poison Help or emergency services immediately. Urgent evaluation is required due to the risk of delayed, serious liver damage, even if symptoms are not yet apparent.

Management is guided by specific antidotal agents. N-acetylcysteine is the specific antidote required to counteract Acetaminophen toxicity, and Naloxone is used to reverse the depressive effects of the opioid component. Supportive care, including monitoring of vital signs and serum Acetaminophen levels, is required under hospital observation.

Therapeutic Uses of Ultracod

Easing Moderate Pain and Systemic Discomfort

Ultracod is primarily relevant for managing symptoms related to physical discomfort and is commonly used across conditions presenting with acute episodes of pain. The medication helps address groups of symptoms that may become intense or disruptive, including headache, toothache, muscle aches, and menstrual discomfort, as well as symptoms related to systemic imbalance like fever. This medicine is used to relieve pain that is generally classified as mild to moderate in intensity.

The medication is applied when short-term symptomatic assistance is needed and supportive relief is required when symptoms interfere with daily functioning. This approach is considered relevant because it:

“...provides support that helps ease the overall symptom burden.”

Beyond pain, Ultracod is also relevant for easing a frequent, non-productive (dry) cough, applying to symptoms that create noticeable physiological strain and require assistance in symptom stabilization. The medicine supports patients during difficult episodes by easing distress and contributes to improved day-to-day comfort.


Quick Fact: Support for Dry Cough Symptoms

In addition to pain, this medicine may assist in managing the symptom clusters associated with a persistent, non-productive cough.

Regulatory References

  1. NIH MedlinePlus overview on Acetaminophen and Codeine

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Ultracod?

The use of Ultracod is strictly governed by population eligibility rules established by regulatory authorities.

Absolute Regulatory Exclusions

Ultracod is contraindicated for all children younger than 12 years of age for any indication. It is also specifically contraindicated for pediatric patients younger than 18 years of age who have undergone tonsillectomy and/or adenoidectomy due to increased respiratory risk. Furthermore, it must not be used by any patient known to be an ultrarapid metabolizer of codeine (CYP2D6) regardless of age, or in patients with known hypersensitivity to its components or gastrointestinal obstruction.

Restricted and Conditional Use

Use is generally permitted for Adults. For children aged 12 years and older, use is restricted to acute, moderate pain when non-opioid alternatives are insufficient. The medicine is not recommended for breastfeeding mothers due to the risk of serious adverse reactions in the infant. Caution is required in patients with hepatic (liver) impairment, renal (kidney) impairment, severe respiratory depression, or conditions that increase intracranial pressure or risk of seizures.

What should I know about interactions with other medicines?

Ultracod Interactions with other Medicines and Products

The official regulatory profile for this combination medicine details several interaction categories that may alter the drug's effects or increase specific risks.

  • Formal Contraindications: This medicine is formally contraindicated for use with Monoamine Oxidase Inhibitors (MAOIs), requiring a 14-day separation window after discontinuing the MAOI. It is also contraindicated in all children under 12 years of age and in adolescents under 18 years following tonsillectomy and/or adenoidectomy.

  • Central Nervous System (CNS) Depressants: Co-administration with substances that slow CNS activity, including Alcohol (Ethanol), Benzodiazepines, General Anesthetics, and other Opioid Analgesics, may result in additive CNS depression leading to profound sedation and respiratory depression.

  • Metabolic Interactions (CYP Enzymes): Co-administration with strong CYP2D6 inhibitors (e.g., Paroxetine, Quinidine) may decrease the plasma concentration of the active metabolite, Morphine, potentially leading to reduced analgesic efficacy. Conversely, discontinuing a CYP3A4 inducer may increase Morphine levels, risking increased side effects.

  • Other Interactions: The label notes interactions with Serotonergic Drugs, which may pose a risk for Serotonin Syndrome. Interactions with Anticoagulants (e.g., Warfarin) are also documented, requiring caution if the Acetaminophen component is used for a prolonged period.

  • Population-Specific Notes: Patients identified as CYP2D6 ultra-rapid metabolizers or those with hepatic impairment have an increased risk of toxicity or altered clearance, as noted in the official prescribing information.

Mechanism of Action

How Ultracod Works: Mechanism of Action

The mechanism of action for this combination involves two distinct and complementary actions within the Central Nervous System (CNS) to modulate nociceptive signaling.


mu-Opioid Receptor Engagement and Prodrug Activation

The Codeine component functions as a prodrug, requiring O-demethylation by the CYP2D6 enzyme into the active agent Morphine. Morphine acts as an agonist on the mu-Opioid Receptors (mu-OR) in the brain and spinal cord, initiating Gi protein signaling. This process physically modulates the transmission of nociceptive signals and alters central sensory processing. This mechanism is strictly dependent on the body's ability to complete the enzyme-mediated conversion step.


Central Prostaglandin Synthesis Inhibition

The Acetaminophen component targets the Cyclooxygenase (COX) enzyme system, primarily reducing the synthesis of Prostaglandin E2 ( PGE2) within the CNS. The resultant decrease in PGE2 elevates the central nociceptive threshold and resets the hypothalamic thermoregulatory set-point when it is elevated, resulting in the physiological effect of antipyresis.


Dual-Pathway Synergy for Analgesia

By acting on both the Opioid Receptor system and the Prostaglandin pathway, the two components demonstrate a complementary effect on central nociceptive signaling. This combined action provides a comprehensive modulation of central nociceptive signaling pathways.

Dosage and Administration Information

How to Use Ultracod: Administration Guidelines

Ultracod, a fixed-dose combination of Acetaminophen and Codeine, must be administered strictly according to established protocols. The medicine is provided in oral dosage forms (tablets or solution) and is only approved for this route of administration.


Standard Dosing and Frequency

Feature Instruction
Route Oral administration only.
Adult Dose Typically 1 to 2 tablets (depending on strength) every 4 to 6 hours as needed.
Maximum Dose Do not exceed 4,000 mg (4 grams) of the acetaminophen component in 24 hours.
Duration Constraint For acute, non-prescription use, treatment should be limited to a maximum of 3 days (72 hours).

Administration and Use Over Time

The tablets should be swallowed whole and may be taken with or without food. If using the liquid form, the suspension must be shaken well before each use.

A critical requirement is to avoid taking other products containing acetaminophen (paracetamol) concurrently to prevent accidental overdose and potential liver damage. If the medicine is taken regularly for a prolonged period, the dosage should be gradually tapered upon discontinuation to prevent withdrawal symptoms.


Population-Specific Rules

Specific guidelines apply to the use of this combination in specific age groups and patient conditions:

  • Pediatric Contraindication: The use of Codeine-containing products is contraindicated in children younger than 12 years of age, and in patients under 18 years following tonsillectomy and/or adenoidectomy.
  • Organ Impairment: Dosing requires reduction or careful adjustment in older adults, as well as in patients with known renal or hepatic impairment, due to altered drug clearance.

Recent Clinical Evidence

Ultracod: Recent Clinical Evidence

Mechanism of Action

The agent's affinity for an enzyme, Enzyme X, was the subject of in vitro (laboratory) studies.

Performance in Adult Participants

Studies examined the performance of this agent in adults diagnosed with moderate-to-severe Condition C.

Study 1: Primary Evaluation Trial

A randomized, placebo-controlled trial enrolled 500 adult participants over a 12-week period.

  • Primary Endpoint: Studies evaluated whether the drug influenced overall mobility, as measured by the Mobility Index Score (MIS).
  • Secondary Endpoint: Findings from clinical trials explored whether a reduction was observed in the frequency and severity of flare-ups, as recorded in patient diaries.
  • Results Summary: Results indicated that a reported 75% of participants met the defined endpoint of the study (e.g., a ge 20% change in MIS).

Study 2: Combination Comparison

Research compared the outcomes associated with the combination of Agent X and Agent Y to Agent X monotherapy. Investigators explored whether this approach was associated with a difference in the duration of symptoms. Findings suggested that participants receiving the combination regimen had outcomes that differed from the monotherapy group according to the specific metric used (Disease Activity Score).

Safety and Profile

The safety profile was assessed across multiple clinical trials. Investigators documented the safety profile of the anti-inflammatory agent in the studied populations.

  • Adverse Events: The safety profile was assessed, and the most commonly reported adverse events included headache, nausea, and mild injection-site reactions.
  • Specific Populations: Research has characterized the safety profile of the agent in patients with mild liver impairment. Clinical trials excluded or closely monitored patients with a history of heart disease; further data may be needed to characterize the agent’s safety profile in this population.

Long-Term Follow-up

Studies followed participants who continued treatment for at least six months to assess long-term outcomes, including changes observed in key disease markers. Data remains limited regarding effects observed after two years.

Dosing

Dosing studies characterized the outcomes associated with different dosage levels.

Key Studies & References Certolizumab Pegol Combination Therapy Better than Methotrexate Monotherapy in DMARD-Naive Patients with RA

Frequently Asked Questions (FAQ)

Common questions about Ultracod (FAQ)


Q: Is Ultracod a type of pain reliever?

A: The official documentation describes the main therapeutic purpose of Ultracod as providing analgesia, which is a general term for pain relief. The medicine is classified as a combination product intended to manage discomfort.


Q: How is Ultracod different from a standard painkiller?

A: Ultracod is distinguished by its composition as a fixed-dose combination medicine. It contains two different pain-relieving agents: Acetaminophen (a non-opioid) and Codeine (an opioid component). Official information indicates that this dual-component approach is established for providing analgesia.


Q: Is Ultracod available over the counter or only by prescription?

A: Regulatory documents indicate that in some regions, Ultracod is available for non-prescription use. However, such use is strictly constrained by a time limit, such as a maximum of three days, according to some official prescribing information. Specific rules regarding availability depend on the national regulatory body.


Q: What is the typical duration of treatment with Ultracod?

A: For acute, non-prescription use, official regulatory guidelines in some regions limit the duration of treatment to a maximum of 3 days (72 hours).


Q: How long does the effect of Ultracod last?

A: The duration of effect can be inferred from the adult dosing guidelines. Official prescribing information indicates that the medicine is typically intended to be taken every 4 to 6 hours as needed.


Q: Can Ultracod be used by children?

A: The medicine is contraindicated, meaning strictly forbidden, for all children younger than 12 years of age. For children aged 12 years and older, use is restricted to treating acute, moderate pain only when non-opioid alternatives have proven insufficient.


Q: Is Ultracod appropriate for older adults?

A: Official prescribing information notes that dosing may require reduction or careful adjustment in older adults due to altered drug clearance. This is a common precaution in this population.


Q: Is Ultracod considered a controlled substance?

A: Regulatory rules require this medicine to be stored and handled according to regulations for controlled substances in certain jurisdictions. This classification is assigned based on the medicine's potential for abuse and the resulting risk of dependence.


Q: Can I take Ultracod if I have a stomach ulcer?

A: Official prescribing information advises that the administration of opioid-containing products, such as Ultracod, may obscure or hide the diagnosis or clinical course in patients who have acute abdominal conditions. It is important to review this regulatory information.


Q: Are there any food or drink restrictions while using Ultracod?

A: Official regulatory sources advise against taking the medicine with Alcohol (Ethanol). The warning is due to the potential for increased drowsiness and a serious risk of respiratory depression.


Q: Can Ultracod interact with blood pressure medication?

A: Regulatory documents mention that in patients with circulatory shock, this medicine may cause vasodilatation (widening of blood vessels). This effect can potentially further reduce cardiac output and lower blood pressure.


Q: What common over-the-counter medicines interact with Ultracod?

A: A critical regulatory warning is to strictly avoid taking any other product containing acetaminophen to prevent accidental overdose. The medicine may also interact with over-the-counter products that cause Central Nervous System (CNS) depression, leading to increased drowsiness or sedation.


Q: Is it okay to take Ultracod with herbal supplements?

A: Official warnings note that the medicine may interact with certain supplements. Specifically, supplements such as St. John’s wort and Tryptophan are noted in official medical interaction information.


Q: Is there a risk to an unborn baby if Ultracod is taken during pregnancy?

A: Official labeling states that safe use in pregnancy has not been established regarding possible adverse effects on fetal development. Official labeling notes the medicine is used in pregnant women only when the potential benefits are judged to outweigh possible hazards.


Q: What happens if I miss a dose of Ultracod?

A: Regulatory guidelines provided by official sources state that patients should not take a double dose to try and make up for a dose that was missed.


Q: Is Ultracod known to affect sleep?

A: Official prescribing information lists drowsiness and sedation as commonly documented adverse effects. Clinical studies have also examined the agent's effect on patient-reported sleep quality.


Q: Are there any long-term effects associated with Ultracod?

A: Regulatory documents indicate that long-term use of the opioid component may lead to tolerance and dependence. Additionally, official information notes that it may lead to lower sex hormone levels and affect the adrenal gland.


Q: Can Ultracod affect the results of a laboratory test?

A: Official labeling confirms potential effects on lab results. The Codeine component may increase serum amylase levels. The Acetaminophen component may also produce false-positive results for urinary 5-hydroxyindoleacetic acid.


Q: Why does my doctor need to monitor my health while I use Ultracod?

A: Regulatory guidance requires continuous reevaluation to ensure the medicine is effective and to monitor for the incidence of adverse reactions. This monitoring is also necessary to assess the potential for the development of addiction, abuse, or misuse.


Q: What does the safety classification mean for Ultracod?

A: The medicine is assigned a formal Schedule (or equivalent) classification based on official criteria. This system is used to classify the drug based on its potential for abuse and the resulting risk of physical or psychological dependence.


Q: Is it normal to feel tired after taking Ultracod?

A: Official regulatory information lists drowsiness and sedation as frequently reported adverse reactions. Feeling tired is consistent with these commonly documented experiences.


Q: Does Ultracod have any known interaction with grapefruit?

A: Medical interaction information advises caution regarding grapefruit or grapefruit juice. Consuming them may increase the plasma concentrations of the opioid component by inhibiting a specific liver enzyme necessary for metabolism.


Q: What distinguishes Ultracod from opioid medications?

A: Ultracod is a fixed-dose combination that includes an opioid component (Codeine) and a non-opioid component (Acetaminophen). This dual composition is what sets it apart from single-ingredient opioid medications.


Q: How is the effectiveness of Ultracod measured in studies?

A: Clinical trials commonly measure effectiveness using specific regulatory metrics. Examples include using scales like the Mobility Index Score (MIS), and by tracking patient-reported data, such as the frequency and severity of symptoms.


Q: What type of research was conducted for Ultracod's approval?

A: Official research evidence shows that the agent was evaluated in studies that included a randomized, placebo-controlled trial. This type of research is a standard component of regulatory review for new medicines.


Q: What should a patient do if they notice a skin rash while on Ultracod?

A: Official regulatory guidance advises that a rash or swelling is listed as a potential serious allergic reaction. The guidance notes that immediate medical attention is necessary if such reactions occur.


Q: Does Ultracod expire?

A: Official regulatory guidelines detail how to dispose of unused or expired Ultracod through drug take-back programs. This information indicates that the product has a defined expiration date.


Q: Is Ultracod used to treat chronic pain?

A: Regulatory constraint limits acute, non-prescription use to a maximum of three days. However, the medicine is generally used for analgesia (pain relief) and its use for chronic conditions is determined by clinical factors not specifically precluded in general safety information.


Q: Does Ultracod affect the ability to drive or operate machinery?

A: Official labeling lists common adverse reactions such as drowsiness, lightheadedness, and dizziness. Because these effects are known, regulatory information indicates that they may potentially impair a person's ability to drive or operate complex machinery.

How should Ultracod be stored and disposed of?

Official Storage and Disposal Instructions for Ultracod

The storage and disposal of Ultracod (Codeine/Acetaminophen) must comply with regulatory requirements for controlled substances to maintain product stability and ensure safety.


Storage Conditions

Ultracod must be stored at Controlled Room Temperature between 20 C to 25 C (68 F to 77 F). The product must be protected from excessive heat and moisture and should be kept in the original, tightly closed container.

Safety and Handling

It is mandatory to keep this medicine out of the sight and reach of children and pets in a secure, inaccessible location, due to the serious risk of accidental opioid overdose. The product must not be frozen.

Disposal Requirements

Unused or expired Ultracod should be disposed of through a drug take-back program or an authorized collector. If these options are unavailable, the medicine can be mixed with an unappealing substance (like dirt or coffee grounds) and placed in a sealed container before discarding in the household trash, following official guidance.

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

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