Acetylcysteine is an active pharmaceutical ingredient in the Mucolytics group (R05CB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised October 17, 2025[1]
Acetylcysteine is indicated for pulmonary conditions, requiring viscosity reduction of the bronchial secretion to facilitate productive coughing, such as in bronchitis, emphysema, mucoviscidose, and bronchiectasis. AceCil 600 mg Effervescent Tablets is indicated in adults only.
How to take
GB
CACanada· Health Canada
5 products
Uses
CAOfficial regulatory label· revised March 19, 2026[2]
AND CLINICAL USE....................................................................................... 3 CONTRAINDICATIONS ............................................................................................................
3 WARNINGS AND PRECAUTIONS .......................................................................................... 3 ADVERSE REACTIONS ............................................................................................................
6 DRUG INTERACTIONS ............................................................................................................. 7 DOSAGE AND ADMINISTRATION .........................................................................................
7 OVERDOSAGE ......................................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY .....................................................................
USUnited States· FDA
1 product
Uses
USOfficial regulatory label· revised September 14, 2023[3]
Indications and Usage:
Folcyteine™ is indicated to provide vitamin supplement to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood
How to take
Drug interactions
Known interactions involving Acetylcysteine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 241. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL437070005 · revised October 17, 2025
[2]Health Canada (DPD) · 02243098 · revised March 19, 2026
[3]FDA DailyMed · 04cf0026-e29b-ff… · revised September 14, 2023 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Posology Adults 600 mg (1 effervescent tablet) once daily. 3). Children 2 years of age and older, and adolescents The safety and efficacy is not established in children aged 2 years and older and adolescents. Other forms and strengths of acetylcysteine are more suitable for these patient groups.
Method of administration Administer the required dose by dissolving an effervescent tablet in half a glass of water, to obtain a solution which can be ingested directly. Patients with a muffled cough reflex (elderly and debilitated patients) are advised to take the tablet in the morning.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised October 17, 2025[1]
In below table adverse effects after systemic use of oral acetylcysteine are indicated according to organ class. 000) Not known Immune system disorders Hypersensitivity reactions* Anaphylacti c shock, anaphylacti c/ anaphylatoi d reactions Nervous system disorders Headache Ear and labyrinth disorders Tinnitus Vascular disease Haemorrhag e Gastrointestinal disorders Stomatitis, abdominal pain, nausea, vomiting, diarrhoea Dyspepsia Skin and subcutaneous tissue disorders Facial oedema General disorders and administration site disorders Pyrexia Investigations Hypotension * Hypersensitivity reactions include bronchospasm, dyspnoea, pruritus, urticarial, rash, angioedema and tachycardia.
A decrease in platelet aggregation in the presence of acetylcysteine is confirmed in several studies. The clinical significance of this is not yet established. In patients with peptic ulcer or peptic ulcer history acetylcysteine may have an unfavourable effect on the gastric mucosa.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised October 17, 2025[1]
Bronchospasms may occur with the use of acetylcysteine. If bronchospasms occur, the medicinal product should be discontinued immediately. Caution is advised in patients with peptic ulcer disease in their history, especially when using concomitantly other medicines known to irritate the gastrointestinal tract mucous.
In very rare cases, the occurrence of serious skin reactions such as Stevens- Johnson syndrome and Lyell's syndrome have been reported when acetylcysteine was used in the same time period. In most cases at least one co suspected drug could be identified, which was more likely the cause of the mucocutaneous syndrome.
If new skin or mucosal changes are seen immediate medical advice should be sought and treatment with acetylcysteine should be discontinued. Mainly at the beginning of the treatment with acetylcysteine bronchial secretion can become fluid and increase in volume.
When a patient is unable to effectively cough up the secretions, postural drainage and broncho- aspiration have to be performed. AceCil 600 mg Effervescent Tablets are sugar-free and can therefore be used by diabetics. 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Caution is advised in patients on a controlled sodium diet. In homozygous patients with phenylketonuria the amount of phenylalanine supplied by aspartame in this product should be taken into account in their dietary prescription. Paediatric population Mucolytics can block the airways of children under the age of 2 due to physiological characteristics of the respiratory system in this age group.
The ability to cough up mucus may be limited. Therefore mucolytics should not be used in children younger than 2 years. The safety and efficacy is not established in children aged 2 years and older and in adolescents. 2). Not fully dissolved tablets present a risk of choking and aspiration, particularly to elderly patients.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised October 17, 2025[1]
1. The tablets should not be used in children under 2 years of age. The tablets should not be used in children and pregnant women with phenylketonuria.
This is not medical advice. Consult a qualified healthcare professional.
17 STORAGE AND STABILITY .................................................................................................. 18 SPECIAL HANDLING INSTRUCTIONS ................................................................................
19 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................... 19 PART II: SCIENTIFIC INFORMATION ................................................................................ 20 PHARMACEUTICAL INFORMATION ..................................................................................
21 REFERENCES ........................................................................................................................... 23 PART III: PATIENT MEDICATION INFORMATION.........................................................
24 Acetylcysteine Solution Page 3 of 30 ACETYLCYSTEINE SOLUTION Sandoz Standard 200 mg/mL PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Nonmedicinal Ingredients Inhalation, Oral, Intravenous Solution / 200 mg/mL Disodium Edetate, Sodium Hydroxide , water for injection INDICATIONS AND CLINICAL USE Acetylcysteine Solution is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as: chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung); acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis); pulmonary complications of cystic fibrosis; post tracheostomy care; pulmonary complications associated with surgery; use during anesthesia; post-traumatic chest conditions; atelectasis due to mucous obstruction; diagnostic bronchial studies (bronchograms, bronchospirometry and bronchial wedge catheterization).
Acetylcysteine Solution administered orally or intravenously is also indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. CONTRAINDICATIONS Acetylcysteine Solution is contraindicated in those patients who are sensitive to the drug or to any of the inactive ingredients.
There are no contraindications to oral or intravenous administration of acetylcysteine in the treatment of acetaminophen overdose. WARNINGS AND PRECAUTIONS General With the administration of acetylcysteine as a mucolytic agent, the patient may initially notice a Acetylcysteine Solution Page 4 of 30 slight disagreeable odor which soon becomes not noticeable.
With a face mask, there may be stickiness on the face after nebulization which is easily removed by washing with water. Acetylcysteine is not compatible with rubber and metals, particularly iron, copper and nickel. Silicone and lacquered rubber and plastic are satisfactory for use with acetylcysteine.
Under certain conditions, a colour change may take place in the solution of acetylcysteine in the opened vial. The light purple colour is the result of a chemical reaction which does not significantly impair the safety or mucolytic efficacy of acetylcysteine.
Continued nebulization of an acetylcysteine solution with a dry gas will result in an increased concentration of the drug in the nebulizer because of evaporation of the solvent. Extreme concentration may impede nebulization and efficient delivery of the drug.
Dilution of the nebulizing solution with Sterile Water for Injection, as concentration occurs, will obviate this problem. Fluid overload Intravenous administration of acetylcysteine can cause fluid overload, potentially resulting in hyponatraemia, seizure and death.
Use with caution in children, patients requiring fluid restriction or those who weigh less than 40 kg because of the risk of fluid overload. To avoid fluid overload, use the recommended dilution shown in Table 3 (see DOSAGE AND ADMINISTRATION).
Gastrointestinal Occasionally severe and persistent vomiting occurs as a symptom of acute acetaminophen overdose. Treatment with oral acetylcysteine may aggravate the vomiting. g. ) should be evaluated concerning the risk of upper gastrointestinal hemorrhage versus the risk of developing hepatic toxicity, and treatment with acetylcysteine given accordingly.
Dilution of the acetylcysteine with cola drinks minimizes the propensity of oral acetylcysteine to aggravate vomiting. Hematologic Changes in haemostatic parameters have been observed in association with N-acetylcysteine treatment, some leading to decreased prothrombin time, but most leading to a small increase in prothrombin time.
One (1) Folcyteine™ caplet daily or as directed by a physician. Do not administer to children under the age of 12.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 764 reports total. [4]
Drug Ineffective 83
Off Label Use 77
Pneumonia 44
Dyspnoea 42
Death 41
Pyrexia 37
Condition Aggravated 36
Toxicity To Various Agents 32
Chronic Obstructive Pulmonary Disease 31
Headache 31
Diarrhoea 30
Drug Ineffective For Unapproved Indication 30
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised September 14, 2023[3]
Adverse Reactions:
Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised September 14, 2023[3]
Contraindications:
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Folcyteine™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
This is not medical advice. Consult a qualified healthcare professional.