Acetylcysteine 200 mg/mL
Acetylcysteine · SOLUTION · Cameron Pharmaceuticals
Acetylcysteine is a solution containing acetylcysteine at 200 mg/mL, taken respiratory (inhalation). Manufactured by Cameron Pharmaceuticals.
Key Facts
- Brand Name
- Acetylcysteine
- Generic Name
- Acetylcysteine
- NDC Code (Product)
42494-436- Manufacturer
- Cameron Pharmaceuticals
- Strength
- 200 mg/mL
- Dosage Form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA214177
- Drug Class
- Antidote [EPC]; Antidote for Acetaminophen Overdose [EPC]
- Marketing Start
- 08/21/2025
Recall History
Promise Pharmacy, LLC
Lack of sterility assurance.
The Apothecary Shoppe LLC
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Bedford Pharmacy
Lack of assurance of sterility
Pharmacy Plus, Inc. dba Vital Care Compounder
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Wise Pharmacy
Lack of Processing Controls
Pallimed Solutions
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Ben Venue Laboratories Inc
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI). Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with an acute ingestion or from repeated supratherapeutic ingestion (RSI) ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Pre-Treatment Assessment Following Acute Ingestion ( 2.1 ) : Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion. If the time of acetaminophen ingestion is unknown: Administer a loading dose of acetylcysteine injection immediately. Obtain an acetaminophen concentration to determine need for continued treatment. If the acetaminophen concentration cannot be obtained (or is unavailable or uninterpretable) within the 8-hour time interval after acetaminophen ingestion or there is clinical evidence of acetaminophen toxicity: Administer a loading dose of acetylcysteine injection immediately and continue treatment for a total of three doses over 21 hours. If the patient presents more than 8 hours after ingestion and the time of acute acetaminophen ingestion is known: Administer a loading dose of acetylcysteine injection immediately. Obtain acetaminophen concentration to determine need for continued treatment. If the patient presents less than 8 hours after ingestion and the time of acute acetaminophen ingestion is known and the acetaminophen concentration is known: Use the Rumack-Matthew nomogram ( Figure 1 )…
Contraindications
4 CONTRAINDICATIONS Acetylcysteine is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see Warnings and Precautions ( 5.1 )] . Patients with a previous hypersensitivity reaction to acetylcysteine ( 4 ).
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (> 2%) are rash, urticaria/facial flushing and pruritus ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the literature the most frequently reported adverse reactions attributed to intravenous acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 21%, and they most commonly occur during the initial loading dose of acetylcysteine. Loading Dose/Infusion Rate Study In a randomized, open-label, multi-center clinical study conducted in Australia in patients with acetaminophen poisoning, the rates of hypersensitivity reactions between a 15-minute and 60-minute intravenous infusion for the 150 mg/kg loading dose of acetylcysteine were compared. The incidence…
Frequently Asked Questions
What is Acetylcysteine used for?
Acetylcysteine contains Acetylcysteine. It is a solution taken respiratory (inhalation). Consult your doctor for specific uses.
Is Acetylcysteine a controlled substance?
Acetylcysteine is not classified as a controlled substance by the DEA.
What is the generic name for Acetylcysteine?
The generic name for Acetylcysteine is Acetylcysteine. There are 2 other brand versions of Acetylcysteine.
What is the NDC code for Acetylcysteine 200 mg/mL?
The NDC (National Drug Code) for Acetylcysteine 200 mg/mL is 42494-436, listed by Cameron Pharmaceuticals.