Sulfatrim Pediatric Suspension

Pharmaceutical Associates, Inc

Revision date : 2018-06-18

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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

64-17-5

Name of the chemical

Ethanol

Concentration

N/A

EC/CAS

77-92-9

Name of the chemical

Citric acid

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

EC/CAS

99-76-3

Name of the chemical

4-hydroxybenzoic acid, methyl ester

Concentration

N/A

EC/CAS

9004-34-6

Name of the chemical

cellulose

Concentration

N/A

EC/CAS

9005-65-6

Name of the chemical

polyethyleneglycol sorbitan monooleate

Concentration

N/A

EC/CAS

57-55-6

Name of the chemical

1,2-propanediol

Concentration

N/A

EC/CAS

94-13-3

Name of the chemical

Propylparaben; propyl 4-hydroxybenzoate

Concentration

N/A

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

EC/CAS

57-50-1

Name of the chemical

Sucrose, pure C12H22O11

Concentration

N/A

General Information

Revision date

2018-06-18

Product name

Sulfatrim Pediatric Suspension

1.2.1 Relevant identified uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs,

Emergency telephone

800-424-9300

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Company Information

company name

Pharmaceutical Associates, Inc

Section 2

2.1 Classification of the substance or mixture

This pharmaceutical product is classified as a mixture and is considered non- Hazardous according to the OSHA Hazard Communication Standard 2012 (29 CFR 1910.1200). Chemical family: Antibacterial EU Indication of danger: Not classified. 00

Additional information

Short term: May cause eye and skin irritation. Over-exposure may affect the kidneys and the body’s ability to product urine. Rash or other metabolic symptoms may occur. Allergy-like reactions may develop. Long term: Potential hazard to the liver and blood. Use of sulfamethoxazole and trimethoprim at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia and/or megaloblastic anemia. Known Clinical Effects: Clinical signs, such as rash, sore throat, fever, arthralgia, pallor, purpura or jaundice may be early indications of serious reactions. Cough, shortness of breath, an d pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment. EU Indication of Danger: Toxic to Reproduction: Category 3 Harmful 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. Eye Irritant. Skin Contact: Avoid skin contact. Skin irritant. May cause allergic skin reactions. Inhalation: Not intended for inhalation. May cause allergic respiratory reactions. Ingestion: Generally safe at recommended doses. In case of overdose, seek medical attention immediately. Ingestion in large quantities may be harmful. May cause liver, blood or metabolic disturbances.

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. 00

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