FDA label
What is acetylcysteine used for?
The FDA-approved uses of acetylcysteine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as:”
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Acetylcysteine, solution
Indications and Usage, quoted from the label by Hospira, Inc. (ANDA073664). Cross-references to other label sections are left out.
Acetylcysteine 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
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)
Source: DailyMed label, set id 5558a5f5-e821-473b-7d8a-5d33d09f0586, version 22, effective May 22, 2026. NDC 0409-3307, one of 15 listings for this product.
Acetylcysteine, injection, solution
Indications and Usage, quoted from the label by Sagent Pharmaceuticals (ANDA091684). Cross-references to other label sections are left out.
Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI).
Source: DailyMed label, set id c206c659-16ea-444a-8c60-8a3343400ada, version 15, effective October 26, 2025. NDC 25021-812, one of 10 listings for this product.
Questions
What is acetylcysteine used for?
The FDA label says: “Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as:”
What drug class is acetylcysteine?
FDA lists acetylcysteine in the Antidote and Antidote for Acetaminophen Overdose and Mucolytic established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Acetylcysteine
- Is Acetylcysteine a controlled substance?Federal schedule
- Generic for AcetadoteFDA Orange Book
- Generic for MucomystFDA Orange Book
- Antidotes listFDA drug class
- Antidote for Acetaminophen Overdoses listFDA drug class
- Mucolytics listFDA drug class
- NDC 66220-207Acetylcysteine NDC record
- NDC 0143-9433Acetylcysteine NDC record
- NDC 0409-3307Acetylcysteine NDC record