Acetylcysteine 200 mg/mL Solution — NDC 42494-436-25 (Billing 42494-0436-25)
This is a package of Acetylcysteine 200 mg/mL Solution from Cameron Pharmaceuticals, marketed since Aug 2025 and currently FDA-listed; retail pharmacies pay about $2.25 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 42494-436-25 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 42494 labeler · 436 product · 25 package
- Package marketed since
- Aug 21, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 4249443625 6
- Medicaid fills, this package
- 18 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Acetylcysteine (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 000592
- GCN: 02401
- GPI-14 (Medi-Span): 43300010002005
- HICL (First Databank): 000189
- AHFS class code: 48:24.00.00
- RxCUI (RxNorm): 307718
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Antidote class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Acetylcysteine inhalation is used along with other treatments to relieve chest congestion due to thick or abnormal mucous secretions in people with lung conditions including asthma, emphysema, bronchitis and cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction). Acetylcysteine is in a class of medications called mucolytic agents. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Read the full MedlinePlus article ↗- It has two main uses. It is an antidote that helps protect the liver after an acetaminophen overdose. In inhaled form, it also helps loosen thick, sticky mucus in many lung conditi...
- The injection is given into a vein by healthcare staff, usually starting with a loading dose. The inhaled solution is breathed in as a mist, often a few times a day. Your prescribe...
- The most common ones are rash, hives, facial flushing and itching. Some people have nausea, vomiting or a fast heartbeat. Mild flushing often fades even while the infusion continue...
- Get help for wheezing, shortness of breath, throat tightness, swelling or feeling faint. These can be signs of a serious allergic reaction. If you have asthma, tell your care team...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Acetylcysteine (prescription drug) — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.246 | $224.55 / 100 ml |
| Medicaid paysCMS SDUD · 12 mo | $1.38 | $138.26 / 100 ml |
| Medicare drug plans payPart D · Q2 2026 | $1.53 | $153.23 / 100 ml |
| Medicare Part B allowsASP · J7608 | $7.274 / J7608 unit | — |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 42494-0436-25 You're viewing this Main listing | 25 VIAL in 1 CARTON / 4 mL in 1 VIAL | 2025-08-21 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Acetylcysteine 200 mg/mL 00409-3308-03 | Hospira, | 3 vials | $0.737 | AN | Availability likely | save 67% |
| Acetylcysteine 200 mg/mL 63323-0690-30 | Fresenius | 3 vials | $0.737 | AN | Availability likely | save 67% |
| Acetylcysteine 200 mg/mL 70069-0020-03 | Somerset | 3 vials | $0.737 | AN | Availability likely | save 67% |
| Acetylcysteine 200 mg/mL 63323-0692-10 | Fresenius | 3 vials | $1.318 | AN | Availability likely | save 41% |
| Acetylcysteine 200 mg/mL 00517-7604-25 | American | 25 vials | $2.245 | AN | Availability likely | — |
| Acetylcysteine 200 mg/mLthis 42494-0436-25 | Cameron | 25 vials | $2.245 | AN | Availability likely | — |
| Acetylcysteine 200 mg/mL 63323-0694-04 | Fresenius | 25 vials | $2.245 | AN | Availability likely | — |
| Acetylcysteine 200 mg/mL 70069-0019-25 | Somerset | 25 vials | $2.245 | AN | Availability likely | — |
| Acetylcysteine 200 mg/mL 00517-7610-03 | American | 3 vials | — | AN | FDA listed | — |
| Acetylcysteine 200 mg/mL 55154-5731-05 | Cardinal | 5 vials | — | AN | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Cameron Pharmaceuticals labeler code 42494
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- Phenobarbital Sodium 130 mg/mL Injection NDC 42494-416-03
- Ribavirin 6 g Powder, For Solution NDC 42494-423-01
- Acetylcysteine 100 mg/mL Solution NDC 42494-435-25
- Phenobarbital Sodium 65 mg/mL Injection NDC 42494-441-25
- Phenobarbital Sodium 130 mg/mL Injection NDC 42494-442-25
- CARBOXYMETHYLCELLULOSE SODIUM EYE LUBRICANT CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED 5 mg/mL Solution/ Drops NDC 42494-448-05
- Vancomycin Hydrochloride 125 mg Capsule NDC 42494-450-20
- Vancomycin Hydrochloride 250 mg Capsule NDC 42494-451-20
- Naproxen 375 mg Tablet NDC 42494-453-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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 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)
INDICATIONS AND USAGE Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. It is essential to initiate treatment as soon as possible after the overdose and, in any case, within 24 hours of ingestion.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION General Acetylcysteine solution is available in rubber stoppered glass vials containing 4 or 10 mL. The 20% solution may be diluted to a lesser concentration with either Sodium Chloride Injection, Sodium Chloride Inhalation, Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution may be used undiluted.
Acetylcysteine solution does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. If only a portion of the solution in a vial is used for inhalation, store the remainder in a refrigerator and use within 96 hours. NEBULIZATION-FACE MASK, MOUTH PIECE, TRACHEOSTOMY When nebulized into a face mask, mouth piece, or tracheostomy, 1 to 10 mL of the 20% solution or 2 to 20 mL of the 10% solution may be given every 2 to 6 hours; the recommended dose for most patients is 3 to 5 mL of the 20% solution or 6 to 10 mL of the 10% solution 3 to 4 times a day.
NEBULIZATION TENT, CROUPETTE In special circumstances it may be necessary to nebulize into a tent or Croupette, and this method of use must be individualized to take into account the available equipment and the patient's particular needs. This form of administration requires very large volumes of the solution, occasionally as much as 300 mL during a single treatment period. If a tent or Croupette must be used, the recommended dose is the volume of acetylcysteine solution (using 10% or 20%) that will maintain a very heavy mist in the tent or Croupette for the desired period.
Administration for intermittent or continuous prolonged periods, including overnight, may be desirable. DIRECT INSTILLATION When used by direct instillation, 1 to 2 mL of a 10% to 20% solution may be given as often as every hour. When used for the routine nursing care of patients with tracheostomy, 1 to 2 mL of a 10% to 20% solution may be given every 1 to 4 hours by instillation into the tracheostomy.
Acetylcysteine solution may be introduced directly into a particular segment of the bronchopulmonary tree by inserting (under local anesthesia and direct vision) a small plastic catheter into the trachea. Two to 5 mL of the 20% solution may then be instilled by means of a syringe connected to the catheter. Acetylcysteine solution may also be given through a percutaneous intratracheal catheter.
One to 2 mL of the 20% or 2 to 4 mL of the 10% solution every 1 to 4 hours may then be given by a syringe attached to the catheter. DIAGNOSTIC BRONCHOGRAMS For diagnostic bronchial studies, two to three administrations of 1 to 2 mL of the 20% solution or 2 to 4 mL of the 10% solution should be given by nebulization or by instillation intratracheally, prior to the procedure. Administration of Aerosol MATERIALS Acetylcysteine solution may be administered using conventional nebulizers made of plastic or glass.
Certain materials used in nebulization equipment react with acetylcysteine solution. The most reactive of these are certain metals (notably iron and copper) and rubber. Where materials may come into contact with acetylcysteine solution, parts made of the following acceptable materials should be used: glass, plastic, aluminum, anodized aluminum, chromed metal, tantalum, sterling silver, or stainless steel.
Silver may become tarnished after exposure, but this is not harmful to the drug action or to the patient. NEBULIZING GASES Compressed tank gas (air) or an air compressor should be used to provide pressure for nebulizing the solution. Oxygen may also be used but should be used with the usual precautions in patients with severe respiratory disease and CO 2 retention.
APPARATUS Acetylcysteine solution is usually administered as fine nebulae and the nebulizer used should be capable of providing optimal quantities of a suitable range of particle sizes. Commercially available nebulizers will produce nebulae of acetylcysteine solution satisfactory for retention in the respiratory tract. Most of the nebulizers tested will supply a h… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Acetylcysteine solution is contraindicated in those patients who are sensitive to it.
CONTRAINDICATIONS There are no contraindications to oral administration of acetylcysteine in the treatment of acetaminophen overdose.
⚠️ Warnings ▾
WARNINGS After proper administration of acetylcysteine solution, an increased volume of liquified bronchial secretions may occur. When cough is inadequate, the airway must be maintained open by mechanical suction if necessary. Where there is a mechanical block due to foreign body or local accumulation, the airway should be cleared by endotracheal aspiration, with or without bronchoscopy.
Asthmatics under treatment with acetylcysteine solution should be watched carefully. Most patients with bronchospasm are quickly relieved by the use of a bronchodilator given by nebulization. If bronchospasm progresses, the medication should be discontinued immediately.
WARNINGS Generalized urticaria has been observed rarely in patients receiving oral acetylcysteine for acetaminophen overdose. If this occurs or other allergic symptoms appear, treatment with acetylcysteine should be discontinued unless it is deemed essential and the allergic symptoms can be otherwise controlled. If encephalopathy due to hepatic failure becomes evident, acetylcysteine treatment should be discontinued to avoid further administration of nitrogenous substances.
There are no data indicating that acetylcysteine influences hepatic failure, but this remains a theoretical possibility.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse effects have included stomatitis, nausea, vomiting, fever, rhinorrhea, drowsiness, clamminess, chest tightness, and bronchoconstriction. Clinically overt acetylcysteine induced bronchospasm occurs infrequently and unpredictably even in patients with asthmatic bronchitis or bronchitis complicating bronchial asthma. Acquired sensitization to acetylcysteine has been reported rarely.
Reports of sensitization in patients have not been confirmed by patch testing. Sensitization has been confirmed in several inhalation therapists who reported a history of dermal eruptions after frequent and extended exposure to acetylcysteine. Reports of irritation to the tracheal and bronchial tracts have been received and although hemoptysis has occurred in patients receiving acetylcysteine such findings are not uncommon in patients with bronchopulmonary disease and a causal relationship has not been established.
ADVERSE REACTIONS Oral administration of acetylcysteine, especially in the large doses needed to treat acetaminophen overdose, may result in nausea, vomiting and other gastrointestinal symptoms. Rash with or without mild fever has been observed rarely.
🔄 Drug Interactions ▾
Drug Interactions Drug stability and safety of acetylcysteine when mixed with other drugs in a nebulizer have not been established.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects In a teratology study of acetylcysteine in the rabbit, oral doses of 500 mg/kg/day (2.6 times the human mucolytic dose) were administered to pregnant does by intubation on days 6 through 16 of gestation. Acetylcysteine was found to be nonteratogenic under the conditions of the study. In the rabbit, two groups (one of 14 and one of 16 pregnant females) were exposed to an aerosol of 10% acetylcysteine and 0.05% isoproterenol hydrochloride for 30 or 35 minutes twice a day from the 6th through the 18th day of pregnancy.
No teratogenic effects were observed among the offspring. Teratology and a perinatal and postnatal toxicity study in rats were performed with a combination of acetylcysteine and isoproterenol administered by the inhalation route. In the rat, two groups of 25 pregnant females each were exposed to the aerosol for 30 and 35 minutes, respectively, twice a day from the 6th through the 15th day of gestation.
No teratogenic effects were observed among the offspring. In the pregnant rat (30 rats per group), twice-daily exposure to an aerosol of acetylcysteine and isoproterenol for 30 or 35 minutes from the 15th day of gestation through the 21st day postpartum was without adverse effect on dams or newborns. Reproduction studies of acetylcysteine solution with isoproterenol have been performed in rats and of acetylcysteine alone in rabbits at doses up to 2.6 times the human dose.
These have revealed no evidence of impaired fertility or harm to the fetus due to acetylcysteine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies may not always be predictive of human responses, this drug should be used during pregnancy only if clearly needed.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The viscosity of pulmonary mucous secretions depends on the concentrations of mucoprotein and, to a lesser extent, deoxyribonucleic acid (DNA). The latter increases with increasing purulence owing to the presence of cellular debris. The mucolytic action of acetylcysteine is related to the sulfhydryl group in the molecule.
This group probably "opens" disulfide linkages in mucus thereby lowering the viscosity. The mucolytic activity of acetylcysteine is unaltered by the presence of DNA, and increases with increasing pH. Significant mucolysis occurs between pH 7 and 9.
Acetylcysteine undergoes rapid deacetylation in vivo to yield cysteine or oxidation to yield diacetylcystine. Occasionally, patients exposed to the inhalation of an acetylcysteine aerosol respond with the development of increased airways obstruction of varying and unpredictable severity. Those patients who are reactors cannot be identified a priori from a random patient population.
Even when patients are known to have reacted previously to the inhalation of an acetylcysteine aerosol, they may not react during a subsequent treatment. The converse is also true; patients who have had inhalation treatments of acetylcysteine without incident may still react to subsequent inhalation with increased airways obstruction. Most patients with bronchospasm are quickly relieved by the use of a bronchodilator given by nebulization.
If bronchospasm progresses, the medication should be discontinued immediately.
CLINICAL PHARMACOLOGY (Antidotal) Acetaminophen is rapidly absorbed from the upper gastrointestinal tract with peak plasma levels occurring between 30 and 60 minutes after therapeutic doses and usually within 4 hours following an overdose. The parent compound, which is nontoxic, is extensively metabolized in the liver to form principally the sulfate and glucuronide conjugates which are also nontoxic and are rapidly excreted in the urine. A small fraction of an ingested dose is metabolized in the liver by the cytochrome P-450 mixed function oxidase enzyme system to form a reactive, potentially toxic, intermediate metabolite which preferentially conjugates with hepatic glutathione to form the nontoxic cysteine and mercapturic acid derivatives which are then excreted by the kidney.
Therapeutic doses of acetaminophen do not saturate the glucuronide and sulfate conjugation pathways and do not result in the formation of sufficient reactive metabolite to deplete glutathione stores. However, following ingestion of a large overdose (150 mg/kg or greater) the glucuronide and sulfate conjugation pathways are saturated resulting in a larger fraction of the drug being metabolized via the P-450 pathway. The increased formation of reactive metabolite may deplete the hepatic stores of glutathione with subsequent binding of the metabolite to protein molecules within the hepatocyte resulting in cellular necrosis.
Acetylcysteine has been shown to reduce the extent of liver injury following acetaminophen overdose. Its effectiveness depends on early oral administration, with benefit seen principally in patients treated within 16 hours of the overdose. Acetylcysteine probably protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Acetylcysteine solution is supplied as a clear, colorless liquid in a clear glass vial with an elastomeric stopper and an aluminum seal with a plastic flip-off dust cover containing 4 to 10 mL. The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for Injection, Sodium Chloride for Inhalation, Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution may be used undiluted.
Acetylcysteine solution is sterile and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). Acetylcysteine solution is not for parenteral injection. It is available as: Acetylcysteine solution 10% (100 mg acetylcysteine per mL).
Sterile, not for injection. NDC 42494-435-25 Cartons of twenty-five 4 mL vials NDC 42494-439-03 Cartons of three 10 mL vials, 1 plastic dropper Acetylcysteine solution 20% (200 mg acetylcysteine per mL). Sterile, not for injection.
NDC 42494-436-25 Cartons of twenty-five 4 mL vials NDC 42494-440-03 Cartons of three 10 mL vials, 1 plastic dropper STORAGE Store unopened vials at 20 ° - 25 °C (68 ° - 77 °F); excursions permitted to 15 °- 30 °C (59 ° – 86 °F) (see USP Controlled Room Temperature). Acetylcysteine solution does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. Dilutions of acetylcysteine should be used freshly prepared and utilized within one hour.
If only a portion of the solution in a vial is used, store the remaining undiluted portion in a refrigerator and use within 96 hours. A change in color may occur after opening. This does change the efficacy of the drug.
📦 Storage and Handling ▾
STORAGE Store unopened vials at 20 ° - 25 °C (68 ° - 77 °F); excursions permitted to 15 °- 30 °C (59 ° – 86 °F) (see USP Controlled Room Temperature). Acetylcysteine solution does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. Dilutions of acetylcysteine should be used freshly prepared and utilized within one hour.
If only a portion of the solution in a vial is used, store the remaining undiluted portion in a refrigerator and use within 96 hours. A change in color may occur after opening. This does change the efficacy of the drug.
📋 Description ▾
DESCRIPTION Acetylcysteine solution is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), available as a sterile, unpreserved solutions (not for injection). The solutions contain 20% (Acetylcysteine Solution 20%) or 10% (Acetylcysteine Solution 10%) acetylcysteine, with disodium edetate in water for injection. Sodium hydroxide and/or hydrochloric acid is added to adjust to pH (range 6.0 - 7.5).
Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, L-cysteine. The compound is a white crystalline powder with the molecular formula C 5 H 9 NO 3 S, a molecular weight of 163.2, and chemical name of N-acetyl-L-cysteine. Acetylcysteine has the following structural formula: This product contains the following inactive ingredients: edetate disodium, sodium hydroxide and water for injection.
Chemical Structure
⚠️ Precautions ▾
PRECAUTIONS General With the administration of acetylcysteine solution, the patient may observe initially a slight disagreeable odor that is soon not noticeable. With a face mask there may be stickiness on the face after nebulization. This is easily removed by washing with water.
Under certain conditions, a color change may occur in acetylcysteine solution in the opened bottle. The light purple color is the result of a chemical reaction which does not significantly affect safety or mucolytic effectiveness of acetylcysteine solution. Continued nebulization of 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 appropriate amounts of Sterile Water for Injection, USP, as concentration occurs, will obviate this problem. Drug Interactions Drug stability and safety of acetylcysteine when mixed with other drugs in a nebulizer have not been established.
CARCINOGENESIS, MUTAGENSIS, IMPAIRMENT OF FERTILITY Carcinogenesis Carcinogenicity studies in laboratory animals have not been performed with acetylcysteine alone, nor with acetylcysteine in combination with isoproterenol. Long-term oral studies of acetylcysteine alone in rats (12 months of treatment followed by 6 months of observation) at doses up to 1,000 mg/kg/day (5.2 times the human mucolytic dose) provided no evidence of oncogenic activity. Mutagenesis Published data 1 indicate that acetylcysteine is not mutagenic in the Ames test, both with and without metabolic activation.
Impairment of Fertility A reproductive toxicity test to assess potential impairment of fertility was performed with acetylcysteine (10%) combined with isoproterenol (0.05%) and administered as an aerosol into a chamber of 12.43 cubic meters. The combination was administered for 25, 30, or 35 minutes twice a day for 68 days before mating, to 200 male and 150 female rats; no adverse effects were noted in dams or pups. Females after mating were continued on treatment for the next 42 days.
Reproductive toxicity studies of acetylcysteine in the rat given oral doses of acetylcysteine up to 1,000 mg/kg (5.2 times the human mucolytic dose) have also been reported in the literature. 1 The only adverse effect observed was a slight non-dose-related reduction in fertility at dose levels of 500 or 1,000 mg/kg/day (2.6 or 5.2 times the human mucolytic dose) in the Segment I study. Pregnancy Teratogenic Effects In a teratology study of acetylcysteine in the rabbit, oral doses of 500 mg/kg/day (2.6 times the human mucolytic dose) were administered to pregnant does by intubation on days 6 through 16 of gestation.
Acetylcysteine was found to be nonteratogenic under the conditions of the study. In the rabbit, two groups (one of 14 and one of 16 pregnant females) were exposed to an aerosol of 10% acetylcysteine and 0.05% isoproterenol hydrochloride for 30 or 35 minutes twice a day from the 6th through the 18th day of pregnancy. No teratogenic effects were observed among the offspring.
Teratology and a perinatal and postnatal toxicity study in rats were performed with a combination of acetylcysteine and isoproterenol administered by the inhalation route. In the rat, two groups of 25 pregnant females each were exposed to the aerosol for 30 and 35 minutes, respectively, twice a day from the 6th through the 15th day of gestation. No teratogenic effects were observed among the offspring.
In the pregnant rat (30 rats per group), twice-daily exposure to an aerosol of acetylcysteine and isoproterenol for 30 or 35 minutes from the 15th day of gestation through the 21st day postpartum was without adverse effect on dams or newborns. Reproduction studies of acetylcysteine solution with isoproterenol have been performed in rats and of acetylcysteine alone in rabbits at doses up to 2.6 times the human dose. These have revealed… [Excerpted — this section continues on DailyMed.]
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
CARCINOGENESIS, MUTAGENSIS, IMPAIRMENT OF FERTILITY Carcinogenesis Carcinogenicity studies in laboratory animals have not been performed with acetylcysteine alone, nor with acetylcysteine in combination with isoproterenol. Long-term oral studies of acetylcysteine alone in rats (12 months of treatment followed by 6 months of observation) at doses up to 1,000 mg/kg/day (5.2 times the human mucolytic dose) provided no evidence of oncogenic activity. Mutagenesis Published data 1 indicate that acetylcysteine is not mutagenic in the Ames test, both with and without metabolic activation.
Impairment of Fertility A reproductive toxicity test to assess potential impairment of fertility was performed with acetylcysteine (10%) combined with isoproterenol (0.05%) and administered as an aerosol into a chamber of 12.43 cubic meters. The combination was administered for 25, 30, or 35 minutes twice a day for 68 days before mating, to 200 male and 150 female rats; no adverse effects were noted in dams or pups. Females after mating were continued on treatment for the next 42 days.
Reproductive toxicity studies of acetylcysteine in the rat given oral doses of acetylcysteine up to 1,000 mg/kg (5.2 times the human mucolytic dose) have also been reported in the literature. 1 The only adverse effect observed was a slight non-dose-related reduction in fertility at dose levels of 500 or 1,000 mg/kg/day (2.6 or 5.2 times the human mucolytic dose) in the Segment I study.
📚 References ▾
REFERENCES 1. Bonanomi L, Gazzaniga A. Toxicological, pharmacokinetic and metabolic studies on acetylcysteine. Eur J Respir Dis 1981; 61 (suppl III): 45-51. 2. Am Rev Respir Dis 1960; 82:627-639.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 100 mg/mL Vial Carton NDC 42494-435-25 Rx Only Acetylcysteine Solution, USP 10% (100 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION PRESERVATIVE FREE 25 x 4 mL Vials PRINCIPAL DISPLAY PANEL - 100 mg/mL Vial Carton
PRINCIPAL DISPLAY PANEL - 200 mg/mL Vial Carton NDC 42494-436-25 Rx Only Acetylcysteine Solution, USP 20% (200 mg/mL) For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote) NOT FOR INJECTION PRESERVATIVE FREE 25 x 4 mL Vials PRINCIPAL DISPLAY PANEL - 200 mg/mL Vial Carton