Acetaminophen and Codeine Phosphate Oral Solution USP

Pharmaceutical Associates, Inc

Revision date : 2017-03-07

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

103-90-2

Name of the chemical

N-(4-hydroxyphenyl) acetamide

Concentration

N/A

EC/CAS

64-17-5

Name of the chemical

Ethanol

Concentration

N/A

EC/CAS

57-55-6

Name of the chemical

1,2-propanediol

Concentration

N/A

EC/CAS

57-50-1

Name of the chemical

Sucrose, pure C12H22O11

Concentration

N/A

EC/CAS

56-81-5

Name of the chemical

glycerol

Concentration

N/A

EC/CAS

25956-17-6

Name of the chemical

Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (17); (CI 16035)

Concentration

N/A

General Information

Revision date

2017-03-07

Product name

Acetaminophen and Codeine Phosphate Oral Solution USP

Product Synonyms

Compare to Tylenol® 3

Icons in SDS

Company Information

company name

Pharmaceutical Associates, Inc

Section 2

2.1 Classification of the substance or mixture

This product is a mixture and is a pharmaceutical product. It is considered non- Hazardous according to the OSHA Hazard Communication Standard 2012 (29 CFR 1910.1200). Chemical family: Mixture

Hazard statements

May be harmful if swallowed.

Additional information

Short term: Acetaminophen has been associated with cases of acute liver failure resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product. Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 phenotype. Long term: May be habit forming. Known Clinical Effects: Therapeutic use of this substance has resulted in liver failure, serious skin reactions such as acute generalized exanthematous pustulosis, Stevens- Johnson syndrome and toxic epidermal necrolysis. EU Indication of danger: Not classified. 01 Emergency overview Seek medical attention in case of accidental exposure or overdose. The product is generally safe when used as prescribed. Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential of exposure in your workplace.

Precautionary statements

General advice: Seek medical attention in case of accidental exposure or overdose. Eyes: Avoid contact with eyes. Skin Contact: Avoid skin contact. Inhalation: Not intended for inhalation. Ingestion: Generally safe at recommended doses. In case of overdose, seek medical attention immediately.

Storage

There are no special storage conditions for safety. For product integrity, store under conditions specified on the label.

Disposal

Dispose of in accordance with applicable laws and regulations.

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