General Information
Revision date
2021-04-09
Product name
Olmesartan / Amlodipine Besylate (3.5%) / Hydrochlorothia- zide Formulation
1.2.1 Relevant identified uses
Pharmaceutical
Emergency telephone
215-631-6999
Icons in SDS
Company Information
company name
Organon & Co
e-mail address of the competent person responsible for the Safety Data Sheet
EHSSTEWARD@organon.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H319, H360D, H373, H412
Hazard statements
Code
Statements
H319
Causes serious eye irritation
H360D
May damage the unborn child.
H373
May cause damage to organs through prolonged or repeated exposure
H412
Harmful to aquatic life with long lasting effects
Section 2
CLP CLASSIFICATION
Eye irritation, Category 2 H319: Causes serious eye irritation. Reproductive toxicity, Category 1A H360D: May damage the unborn child. Specific target organ toxicity - repeated H373: May cause damage to organs through pro- exposure, Category 2 longed or repeated exposure. Long-term (chronic) aquatic hazard, Cat- H412: Harmful to aquatic life with long lasting ef- egory 3 fects.
2.2 Label elements
REGULATION (EC) No 1272/2008)
Signal word
Danger
Hazard statements
H319 Causes serious eye irritation. H360D May damage the unborn child. H373 May cause damage to organs through prolonged or repeated exposure. H412 Harmful to aquatic life with long lasting effects.
Prevention
P201 Obtain special instructions before use. P260 Do not breathe dust. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protec- tion/ face protection.
Response
P308 + P313 IF exposed or concerned: Get medical advice/ attention. P337 + P313 If eye irritation persists: Get medical advice/ attention.
Hazardous Ingredients
Olmesartan Hydrochlorothiazide
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumula- tive and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher. May form explosible dust-air mixture if dispersed. Contact with dust can cause mechanical irritation or drying of the skin.
