Simethicone Oral Suspensions/Drops

Pfizer Inc

Revision date : 2025-10-20

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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

201-069-1/77-92-9

Name of the chemical

Citric acid

Concentration

0.09 - 0.5

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

limit (SCL

EC/CAS

63148-62-9

Name of the chemical

polydimethylsiloxane (Mw > 6 800 Da)

Concentration

*

EC/CAS

203-768-7/110-44-1

Name of the chemical

Hexa-2,4-dienoic acid

Concentration

*

EC/CAS

231-545-4/7631-86-9

Name of the chemical

Silver adsorbed on silicon dioxide

Concentration

+ Silicon dioxide, NF

EC/CAS

9004-65-3

Name of the chemical

methylhydroxypropylcellulose

Concentration

>2000

EC/CAS

128-44-9

Name of the chemical

1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt

Concentration

#3_T_CAS_NO

General Information

Version

3

Revision date

2025-10-20

Product name

Simethicone Oral Suspensions/Drops

Product name

Simethicone Oral Suspensions/Drops

Identification on the label/Trade name

SAB Simplex

Chemical name

Not determined

1.2.1 Relevant identified uses

Pharmaceutical product used for gastrointestinal disorders

Emergency telephone

1-800-424-9300, +1-703-527-3887

Icons in SDS

Company Information

company name

Pfizer Inc

e-mail address of the competent person responsible for the Safety Data Sheet

pfizer-MSDS@pfizer.com

GHS Information

Signal word

Not classified

Section 2

SECTION 2: Hazards identification

OSHA Classification of the substance or mixture

2.3 Other hazards

Not applicable (HNOC) An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8). Simethicone Pfizer Occupational Exposure Band (OEB): PBT & vPvB OEB 1 (control exposure to the range of 1000ug/m3 to 3000ug/m3) The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information This product does not contain any known or suspected endocrine disruptors. Note This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients 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 for exposure in your workplace.

Signal word

Not classified

Hazard statements

Not classified in accordance with international standards for workplace safety. Unknown acute toxicity 5 - 10 % of the mixture consists of ingredient(s) of unknown acute oral toxicity. 5 - 10 % of the mixture consists of ingredient(s) of unknown acute dermal toxicity. 5 - 10 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (dust/mist). Unknown aquatic toxicity Contains 5 - 10 % of components with unknown hazards to the aquatic environment.

2.1 Classification of the substance or mixture

GHS - Classification: This mixture is classified as not hazardous according to regulation (EC) 1272/2008 [CLP]. OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable

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