Acetylcysteine Solution, USP

Luitpold Pharmaceuticals, Inc

Revision date : 2015-12-11

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GHS07
Health risk rating 2
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

75-87.5

EC/CAS

1310-73-2

Name of the chemical

sodium hydroxide

Concentration

2.5-5

EC/CAS

7647-01-0

Name of the chemical

Hydrochloric acid

Concentration

Used for pH adjustment

General Information

Version

1.0

Revision date

2015-12-11

Product name

Acetylcysteine Solution, USP

1.2.1 Relevant identified uses

Acetylcysteine Solution, USP, administered orally, is indicated as an antidote to prevent or lesson hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. It is essentail to initiate treatment as soon as possible after the overdose and, in any case, within 24 hours of ingestion. When administered via inhalation it is indicated as adjuvant therapy for patients with abnormal, viscid or inspissated mucous secretions in various respiratory conditions

Emergency telephone

1-800-424-9300

Icons in SDS

GHS07 M004 M009 M017

Company Information

company name

Luitpold Pharmaceuticals, Inc

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H315, H319, H335, H402

Hazard statements

Code

Statements

H315

Causes skin irritation

Section 2

SECTION 2: Hazards identification

Classification (GHS-US) Classification of the Substance or Mixture Classification (GHS-US) Skin Irrit. 2 H315 Eye Irrit. 2A H319 STOT SE 3 H335 Aquatic Acute 3 H402 Full text of H-phrases: see section 16

2.2 Label elements

GHS-US Labeling

Hazard pictograms

GHS07

Signal word

Warning

Hazard statements

H315 - Causes skin irritation. H319 - Causes serious eye irritation. H335 - May cause respiratory irritation. H402 - Harmful to aquatic life.

Precautionary statements

P261 - Avoid breathing vapors, mist, or spray. P264 - Wash hands, forearms, and other exposed areas thoroughly after handling. P271 - Use only outdoors or in a well-ventilated area. P273 - Avoid release to the environment. P280 - Wear protective gloves, protective clothing, and eye protection. P302+P352 - If on skin: Wash with plenty of water. P304+P340 - If inhaled: Remove person to fresh air and keep at rest in a position comfortable for breathing. P305+P351+P338 - If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312 - Call a poison center or doctor if you feel unwell. P321 - Specific treatment (see section 4 on this SDS). P332+P313 - If skin irritation occurs: Get medical advice/attention. P337+P313 - If eye irritation persists: Get medical advice/attention. P362 - Take off contaminated clothing and wash it before reuse. P403+P233 - Store in a well-ventilated place. Keep container tightly closed. P405 - Store locked up. P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations.

Other hazards

Exposure to acetylcysteine may result in gastrointestinal symptoms such as nausea and vomiting as well as stomatitis, fever, rhinorrhea, drowsiness, clamminess, chest tightness, rash and bronchoconstriction. Exposure may cause an allergic reaction in sensitive individuals. Acquired sensitization has been reported. See package insert for additional information

Ingredient(s) with unknown acute toxicity

No data available

2.1 Classification of the substance or mixture

Classification (GHS-US) Skin Irrit. 2 H315 Eye Irrit. 2A H319 STOT SE 3 H335 Aquatic Acute 3 H402 Full text of H-phrases: see section 16

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