ACC 200

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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 ACC 200

What is ACC 200? The Core Identity of the Medicine

Property Description
Active Ingredient Acetylcysteine (N-acetylcysteine or NAC)
Common Form Effervescent Tablets (Oral)
Pharmacological Class Mucolytic Agent, Antidote
Origin Synthetic Derivative (Pro-drug)
Single/Combination Single-Ingredient Product

What is the Core Identity of ACC 200?

ACC 200 is a medicinal preparation whose active ingredient is Acetylcysteine, a substance classified as both a mucolytic agent and an antidote. Acetylcysteine, often referred to as N-acetylcysteine (NAC), is a synthetic derivative of the amino acid L-cysteine and functions as a pro-drug designed to enhance stability and ensure delivery of its active components within the body. This medicine is a single-ingredient product, focusing exclusively on the effects derived from its chemical function as a sulfhydryl donor, an action clinically recognized for altering the physical properties of biological secretions.

What Forms and Types Define Acetylcysteine?

The designation ACC 200 commonly refers to effervescent tablets intended for rapid dissolution in water before oral administration. This effervescent format is a specific characteristic designed to facilitate patient compliance and quicker systemic availability. While primarily known for these oral tablets, Acetylcysteine is also manufactured in sterile solutions for inhalation and intravenous (IV) injection to accommodate its diverse roles. The intravenous route is necessary for high-concentration administration in acute settings to fulfill its time-critical function as an antidote.

What is the General Purpose of This Medicine?

The general purpose of Acetylcysteine is dual: to thin excessive, thick mucus in the airways and to serve as a specific antidote. Its mucolytic action is typically employed to help patients manage viscid respiratory secretions by chemically breaking down their structure, thereby supporting easier clearance. The critical secondary purpose is achieved by replenishing the body’s store of the key antioxidant glutathione, which provides vital organ protection in cases of specific toxic exposure, such as severe acetaminophen overdose.

What side effects are possible with ACC 200?

Possible Side Effects and Safety Information

This section describes the officially documented adverse effects and safety characteristics of Acetylcysteine (the active ingredient in ACC 200), as established in government regulatory documents like the EMA Summary of Product Characteristics and FDA Prescribing Information.

Official Adverse Reactions and Frequency

Adverse reactions are classified by frequency based on clinical data. The most frequently documented effects often relate to the gastrointestinal system.

System-Organ Class Frequency (Example) Adverse Reactions
Gastrointestinal disorders Uncommon / Very Common Nausea, vomiting, abdominal pain, diarrhea
Immune system disorders Uncommon to Very Rare Hypersensitivity reactions, anaphylactic shock
Skin and Subcutaneous Common to Very Rare Skin rash, facial oedema, severe skin reactions

Serious Adverse Reactions

The regulatory label documents rare but serious adverse reactions, including Anaphylactic Shock and other severe allergic responses. Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, are also listed as very rare but critical safety concerns. The potential risk of Upper Gastrointestinal Hemorrhage is noted as a specific vascular safety consideration.

Population-Specific Safety Notes

Specific caution is advised for certain patient groups:

  • Patients with a history of Peptic Ulcer: Use requires caution, as the medicine may affect the gastric mucosa.
  • Patients with Asthma/Bronchospasm History: The regulatory documents advise caution, as the medicine may exacerbate these conditions.

Safety Constraints and Patterns

The medicine is contraindicated in individuals with a known hypersensitivity to Acetylcysteine. Anaphylactoid reactions, especially when the medicine is administered intravenously, often occur rapidly, typically within the first 30 to 60 minutes of initiating the infusion.

Overdose and Emergency Response

Overdose and When to Seek Help

This section summarizes officially documented overdose information for N-acetylcysteine (ACC 200), derived from government regulatory sources.

Documented Overdose Manifestations

Overdose or rapid infusion of N-acetylcysteine may lead to dose-related, non-allergic hypersensitivity-like reactions. Documented manifestations include nausea, vomiting, flushing, rash, pruritus (itching), and local injection site reactions (for the intravenous form). Severe reactions, though rare, can involve the cardiovascular and respiratory systems.

System Documented Symptoms/Signs
Cardiovascular/Systemic Severe hypotension, tachycardia, clamminess, headache
Respiratory Bronchospasm, respiratory distress

Emergency Response and Urgent Care

Official regulatory information emphasizes that no specific antidote exists for an N-acetylcysteine overdose itself; treatment is entirely supportive and symptomatic.

Immediate medical help is required for managing severe or escalating reactions. Official instructions require the following actions:

  • Interrupt or Discontinue Infusion: The N-acetylcysteine infusion must be interrupted or discontinued if severe anaphylactoid symptoms (e.g., severe hypotension, bronchospasm) occur.
  • Symptomatic Management: Supportive care, including the administration of antihistamines or epinephrine, is indicated to manage acute systemic reactions.

Overdose in certain populations requires special care; for example, total fluid volume must be adjusted for pediatric patients to prevent fluid overload and hyponatremia.

Therapeutic Uses of ACC 200

The therapeutic scope of Acetylcysteine is dual, addressing both symptoms related to physical discomfort in the respiratory system and providing supportive protection in toxicology.

Supportive Management of Chronic and Acute Symptoms

For patients experiencing symptoms related to viscid secretions in conditions characterized by periods of heightened symptoms, this medicine is commonly applied to provide supportive symptom management. It is relevant for easing the physical effort required for expectoration in conditions like Chronic Bronchitis, COPD, and Cystic Fibrosis. The medication assists with maintaining functional stability in the airways, which contributes to easing the overall symptom load and supports general well-being. The medicine is also used to address acute symptoms during episodes of severe bronchitis or pneumonia.

“It is applied when patients experience significant airway congestion due to abnormally sticky secretions.”

Therapeutic Use as an Antidote

A distinct therapeutic use is in acute toxic exposures. Here, the medicine acts as a specific antidote for acute acetaminophen overdose. The primary benefit is to provide supportive protection during systemic functional stress related to potential liver damage (hepatotoxicity) that may occur from toxic ingestion. This application is used in clinical settings that involve acute or unstable symptom patterns and offers supportive relief for organs exposed to overwhelming toxic load.


Quick Fact: Relief for Viscid Mucus and Organ Stress

The medicine is used across two main categories of conditions: those involving excessively thick and sticky respiratory secretions (mucolytic function) and acute toxic ingestion (antidote function). It helps address symptoms that create noticeable physiological strain in these distinct clinical settings.

Regulatory References

  1. NIH StatPearls overview on N-Acetylcysteine

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use ACC 200

This section outlines the population eligibility rules for oral acetylcysteine (ACC 200) as documented in official government regulatory sources.

Category Official Regulatory Status
Absolute Contraindication Patients with known hypersensitivity (allergy) to acetylcysteine or any excipient in the product. Children younger than 2 years of age are strictly contraindicated.
Age Eligibility Approved for adults and adolescents (generally over 12 or 14 years). Children from 2 years are approved for use, typically with lower-strength formulations.
Use with Caution Special monitoring is required for patients with bronchial asthma (due to the risk of bronchospasm) and those with a history of peptic ulcers. Caution is also advised for patients with histamine intolerance if long-term therapy is planned.
Pregnancy/Lactation Not recommended for use in pregnancy or while breastfeeding, citing insufficient or limited data for precautionary avoidance.
Comorbidity Restrictions Use is restricted for patients with phenylketonuria (for products containing aspartame) or hereditary fructose intolerance (for products containing sorbitol), due to excipient content.

Regulatory documents define eligibility through absolute prohibitions and conditional use rules. Non-eligibility is established by hypersensitivity, age (under two years), and specific metabolic restrictions based on the product’s non-active ingredients. Eligibility for other populations is governed by age-specific approvals and mandatory caution in the presence of certain pre-existing conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section details officially documented interaction patterns for Acetylcysteine (ACC 200), strictly based on regulatory prescribing information. Interaction constraints primarily involve pharmacodynamic effects, physical exposure changes, and mandatory timing separation with co-administered products.

Documented Pharmacodynamic and Exposure Interactions

Interaction Type Interacting Product or Category Official Regulatory Description
Pharmacodynamic Potentiation Nitroglycerin and related nitrates Co-administration enhances vasodilatory effects, increasing the risk of hypotension and headache.
Pharmacodynamic Opposition Antitussive Drugs (Cough Suppressants) Non-concurrent administration is advised because reducing the cough reflex may lead to a buildup of bronchial secretions.
Exposure Reduction Activated Charcoal The oral effectiveness of Acetylcysteine is reduced by its adsorption to charcoal, an effect particularly relevant when used as an antidote.
Reduced Co-Drug Levels Carbamazepine Co-administration may result in officially documented subtherapeutic Carbamazepine levels.

Timing-Based Administration Requirements

Oral administration of Acetylcysteine requires a mandatory timing separation from certain oral antibiotics (such as Cephalosporins). Regulatory information advises administering these antibiotics at least two hours before or after Acetylcysteine to mitigate the potential for in vitro inactivation of the antibiotic. No specific interaction mechanisms related to CYP enzymes, food, alcohol, or herbal products are explicitly documented in regulatory labels for Acetylcysteine.

Mechanism of Action

Mucolytic Action: Altering Mucus Viscosity

This domain targets the physicochemical structure of mucoproteins within secretions. Acetylcysteine's free sulfhydryl group acts as a chemical effector, initiating a non-enzymatic reaction that breaks down disulfide bonds linking the mucin polymer structure. This chemical modification results in a reduction in the viscosity and elasticity of the secretions, which leads to a modification of the rheological properties of mucus.


Antioxidant Mechanisms: Modulating Cellular Redox State

The second domain involves modulating intracellular redox pathways through the provision of a precursor molecule. Acetylcysteine is a direct precursor to cysteine, which is a rate-limiting component in the biosynthesis of glutathione (GSH). Increasing the availability of cysteine effectively repletes intracellular glutathione reserves. Elevated GSH levels facilitate the neutralization of reactive oxygen species (ROS), resulting in the reduction of oxidative stress markers in the affected pathways.

Dosage and Administration Information

How to Use ACC 200

The administration of Acetylcysteine (ACC 200) is defined by two distinct and non-interchangeable protocols: its routine use as a mucolytic agent and its time-critical use as a specific antidote.


Administration Protocols

Usage Context Official Route and Form Dosing and Frequency Pattern
Mucolytic Support Oral (Effervescent tablet or granule) Standard adult dosing is typically 200 mg taken up to three times daily, with a common maximum of 600 mg per day.
Antidote Protocol Intravenous (IV) or Oral Solution IV: Total dose of 300 mg/kg administered over a fixed sequence of 21 hours. Oral: Total 18 doses administered over 72 hours.

Preparation and Contextual Rules

Mucolytic Administration: The effervescent tablet or granule must be fully dissolved in a glass of water immediately before consumption. To support the intended action of the medicine, instructions often recommend abundant fluid intake.

Antidote Administration: The antidote protocol is a time-critical treatment that requires administration without delay, ideally within eight hours of ingestion. This treatment must be initiated under continuous hospital supervision due to the need for precise, weight-based calculations and complex dilution protocols.

Procedural Constraints: The concentrated solution used for IV infusion must be diluted into a compatible solution prior to administration. For low-weight patients, the total volume of IV fluid may need to be reduced to mitigate the risk of fluid overload, a constraint explicitly stated in prescribing information. In the oral antidote protocol, if a patient vomits within one hour of a scheduled dose, the instruction is to repeat the administration of that specific dose to ensure the full therapeutic course is delivered.

Recent Clinical Evidence

Research evidence / Overview of studies for ACC 200


Evidence for use in Type 2 Diabetes Mellitus

Research has evaluated ACC 200 in adults with Type 2 Diabetes Mellitus, a condition characterized by systemic or functional imbalance. This involved short-term and intermediate-term Randomized Controlled Trials (RCTs) and observational studies. These studies monitored outcomes related to systemic or functional imbalance, such as HbA1c and fasting plasma glucose. Research examined how body weight and lipid profiles were observed in the studied populations.

The findings describe patterns observed in the studies where lower HbA1c and fasting glucose values were observed in some studies. Some trials also reported changes measured during the study period in terms of body weight and triglycerides. However, findings were mixed regarding changes in LDL-C and HDL-C (cholesterol). Long-term outcomes are not fully established beyond the two-year period, as follow-up durations were limited.


Evidence for use in Cardiovascular Risk Reduction

ACC 200 was studied for its application in high-risk patients with Type 2 Diabetes Mellitus who also had established atherosclerotic cardiovascular disease. Large-scale Cardiovascular Outcome Trials (CVOTs) monitored major events such as heart attack, stroke, and cardiovascular death, which are outcomes related to physiological strain or stress. Studies reported patterns related to heart failure hospitalization rates and where the reported occurrence rates of the composite major cardiovascular event endpoint were lower compared to placebo. Long-term outcomes are not fully established beyond the observation period of these trials.


Evidence for use in Chronic Kidney Disease

Research examined ACC 200 in a population of adults with Type 2 Diabetes Mellitus and chronic kidney disease. Dedicated renal outcome trials were evaluated in this group, focusing on a composite renal endpoint and monitored changes in protein levels (UACR). Trials reported patterns where the composite renal endpoint occurrence rate was reduced in the studied population compared to placebo. Changes measured during the study period included lower UACR values.


What is still uncertain about ACC 200

Current research helps highlight what is known — and what is still uncertain. Comparative evidence is lacking for many head-to-head scenarios. Long-term outcomes are not fully established, and data for certain groups remain insufficient, especially for those without Type 2 Diabetes Mellitus who may have similar heart or kidney risks. Evidence quality varies across studies.

Frequently Asked Questions (FAQ)

Common questions about ACC 200 (FAQ)


Q: Is ACC 200 considered a prescription-only medicine?

In some regions, the ACC 200 effervescent tablets are generally available as an over-the-counter (OTC) medicine for temporary use in the treatment of mild illness. Whether it requires a prescription can depend on the specific formulation, intended use, and local regulatory classification.


Q: Do regulatory agencies specify a maximum duration for the use of ACC 200?

For mucolytic support, official instructions often specify a limit on continuous use. According to regulatory guidance, the use of the medicine is generally restricted to no more than 14 days of continuous use unless a healthcare professional has been consulted.


Q: Why is ACC 200 sometimes described as an 'adjunct' treatment?

Official regulatory documents describe the medicine’s role as a mucolytic adjuvant (or complementary agent) in therapy. This means it is used to support and enhance the main treatment plan for respiratory disorders that involve thick, excessive mucus secretions.


Q: What common over-the-counter medicines are described as having an interaction risk with ACC 200?

Officially documented constraints include a recommended timing separation from certain oral antibiotics, such as Cephalosporins. There is also an interaction constraint with Nitroglycerin, where co-administration can increase the risk of low blood pressure.


Q: Are there any specific foods or drinks that should be avoided while using ACC 200?

Regulatory prescribing information does not list any specific foods or drinks that must be avoided while using this medicine. The medicine is instructed to be dissolved in a glass of water before consumption. Official instructions often describe the importance of abundant fluid intake to support the medicine’s mucolytic action.


Q: What does the package insert say about driving or operating machinery while using ACC 200?

Official regulatory documents do not list any known adverse effects that are specifically expected to impair the ability to drive or safely operate machinery. If any unusual effects or reduced alertness are experienced, regulatory information suggests these concerns should be reviewed by a healthcare professional.


Q: What are the long-term safety expectations associated with using ACC 200?

Studies and official information highlight that long-term outcomes have not been fully established for the medicine’s use. This is primarily because the duration of patient follow-up in the reviewed clinical trials was limited, typically not extending beyond a two-year period.


Q: Why do official sources list specific warnings about liver function and ACC 200?

The association with liver function is primarily due to the active ingredient's critical regulatory role as an antidote. Acetylcysteine is officially used to help prevent liver injury following specific toxic exposure, such as severe acetaminophen overdose, which is the main context for this warning.


Q: Does ACC 200 affect blood pressure?

Hypotension (low blood pressure) is documented as an uncommon adverse reaction associated with the use of the medicine. This is listed in official documents detailing the medicine's general safety profile.


Q: Does ACC 200 contain any common allergens like lactose or gluten?

The ACC 200 effervescent tablets contain lactose anhydrous as an inactive ingredient, as documented in regulatory lists. Official documents indicate that patients with specific sensitivities, such as lactose intolerance, may need to review the excipient list. Information regarding gluten content is not consistently detailed across regulatory documents.

How should ACC 200 be stored and disposed of?

How to Store and Dispose of ACC 200?

ACC 200 effervescent tablets must be stored according to strict regulatory conditions to maintain their stability and efficacy.

Official Storage Requirements

Condition Requirement
Temperature Store at or below 25 C (77 F).
Protection Store in a cool, dry place and be protected from light.
Container Rule Keep in the original container, tightly closed.
Child Safety Must be stored out of the sight and reach of children.

The product must not be used after the expiry date printed on the packaging.

Disposal Instructions

Regulatory protocols for disposal must be followed to protect the environment. Unused or expired medicine should be returned to a pharmacist for appropriate disposal. It is explicitly forbidden to dispose of ACC 200 in drains or sewerage systems (wastewater).

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

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