Sinequan (Doxepin hydrochloride) oral concentrate

Pfizer Inc

Revision date : 2025-06-14

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GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 3

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-289-5/56-81-5

Name of the chemical

glycerol

Concentration

N/A

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

202-307-7/94-13-3

Name of the chemical

Propylparaben; propyl 4-hydroxybenzoate

Concentration

N/A

EC/CAS

202-785-7/8006-90-4

Name of the chemical

Mentha piperita oil (40)

Concentration

N/A

EC/CAS

202-785-7/99-76-3

Name of the chemical

4-hydroxybenzoic acid, methyl ester

Concentration

N/A

General Information

Version

6

Revision date

2025-06-14

Product name

Sinequan (Doxepin hydrochloride) oral concentrate

Product name

Sinequan (Doxepin hydrochloride) oral concentrate

Identification on the label/Trade name

Sinequan

Chemical name

Mixture

1.2.1 Relevant identified uses

Pharmaceutical product used as antidepressant antianxiety agent

Emergency telephone

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

Icons in SDS

GHS08 M004 M009 M010 M011 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

Warning

Hazard Codes

Hazard statements (CLP)

H361f, H362, H412

Hazard statements

Code

Statements

H361f

Suspected of damaging fertility

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).

Signal word

Warning

Hazard statements

H361f - Suspected of damaging fertility H362 - May cause harm to breast-fed children H412 - Harmful to aquatic life with long lasting effects

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/fume/gas/mist/vapors/spray P263 - Avoid contact during pregnancy/while nursing P264 - Wash hands thoroughly after handling P270 - Do not eat, drink or smoke when using this product P273 - Avoid release to the environment 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 Chemical name This product does not contain any known or suspected endocrine disruptors.

2.1 Classification of the substance or mixture

GHS - Classification: Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Reproductive toxicity Category 2 - (H361f, H362) Effects on or via lactation Yes Hazardous to the aquatic environment - acute Category 3 - (H402) Hazardous to the aquatic environment - chronic Category 3 - (H412) 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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