Spironolactone Tablets

Pfizer Inc

Revision date : 2025-06-13

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GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-133-6/9005-25-8

Name of the chemical

Starch

Concentration

10-20%

EC/CAS

25322-68-3

Name of the chemical

polyethyleneglycol

Concentration

limit (SCL

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

N/A

EC/CAS

8006-90-4

Name of the chemical

Mentha piperita oil (40)

Concentration

N/A

EC/CAS

9004-65-3

Name of the chemical

methylhydroxypropylcellulose

Concentration

N/A

EC/CAS

232-679-6

Name of the chemical

Starch

Concentration

limit (SCL

EC/CAS

209-150-3

Name of the chemical

Aluminium, zinc, magnesium and calcium stearates

Concentration

N/A

General Information

Version

4

Revision date

2025-06-13

Product name

Spironolactone Tablets

Product name

Spironolactone Tablets

Identification on the label/Trade name

ALDACTONE; ALDACTONE-A; PRACTON; SPIRONOLACTONE-PFIZER

Chemical name

Mixture

1.2.1 Relevant identified uses

Pharmaceutical product for the treatment of high blood pressure (hypertension)

Emergency telephone

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

Icons in SDS

GHS08 M004 M009 M010 M017

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

Danger

Hazard Codes

Hazard statements (CLP)

H351, H360D, H373

Hazard statements

Code

Statements

H351

Suspected of causing cancer

Section 2

SECTION 2: Hazards identification

OSHA Classification of the substance or mixture Carcinogenicity Category 2 Reproductive toxicity Category 1B Specific target organ toxicity (repeated exposure) Category 2

2.3 Other hazards

Not applicable (HNOC) An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8).

Signal word

Danger

Hazard statements

H351 - Suspected of causing cancer H360D - May damage the unborn child H373 - May cause damage to organs through prolonged or repeated exposure; blood, liver, reproductive system.

Precautionary statements

P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P260 - Do not breathe dust P280 - Wear protective gloves and protective clothing P308 + P313 - IF exposed or concerned: Get medical advice/attention P405 - Store locked up P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations as applicable

PBT Substances

& vPvB 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.

2.1 Classification of the substance or mixture

Carcinogenicity Category 2 Reproductive toxicity Category 1B Specific target organ toxicity (repeated exposure) Category 2 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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