Linzess

Allergan plc

Revision date : 2018-09-29

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GHS07 GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

10043-52-4

Name of the chemical

calcium chloride

Concentration

N/A

EC/CAS

9004-34-6

Name of the chemical

cellulose

Concentration

N/A

EC/CAS

9000-70-8

Name of the chemical

gelatin

Concentration

N/A

EC/CAS

14807-96-6

Name of the chemical

Talc

Concentration

N/A

EC/CAS

238-877-9

Name of the chemical

Talc: Hydrated magnesium silicate

Concentration

N/A

General Information

Revision date

2018-09-29

Product name

Linzess

Product Synonyms

Linaclotide

1.2.1 Relevant identified uses

LINZESS is a guanylate cyclase-C agonist indicated in adults for treatment of:• Irritable

Manufacturer Name

Allergan plc

Emergency telephone

Call CHEMTREC Day or Night

Icons in SDS

Company Information

company name

Allergan plc

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

SDS@Allergan.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H302, H319, H373

Hazard statements

Code

Statements

H302

Harmful if swallowed

Section 2

2.1 Classification of the substance or mixture

OSHA Regulatory Status This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Acute toxicity - Oral Category 4 Serious eye damage/eye irritation Category 2 Specific target organ toxicity (repeated exposure) Category 2

2.2 Label elements

Emergency Overview Warning

Hazard statements

H302 - Harmful if swallowed H319 - Causes serious eye irritation H373 - May cause damage to organs through prolonged or repeated exposure Appearance Capsule Physical state Solid Odor No information available Chemical Name Symptoms Linaclotide The most commonly reported adverse reaction is diarrhea. Chemical Name

Medical Conditions Generally Aggravated by Exposure

Linaclotide This medication is contraindicated in children younger than 6 years old, and avoided in age groups 6-17 years old.

Precautionary statements

P270 - Do not eat, drink or smoke when using this product P301 + P312 - IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell P330 - Rinse mouth P264 - Wash face, hands and any exposed skin thoroughly after handling P280 - Wear protective gloves/protective clothing/eye protection/face protection P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing P337 + P313 - If eye irritation persists: Get medical advice/attention P260 - Do not breathe dust/fume/gas/mist/vapors/spray P314 - Get medical advice/attention if you feel unwell P501 - Dispose of contents/ container to an approved waste disposal plant

Further information

Unknown Acute Toxicity 10% of the mixture consists of ingredient(s) of unknown toxicity Over the counter drugs in their solid form are considered exempt under the criteria of the Federal OSHA Hazard Communication Standard 20 CFR 1910.1200. However, in an industrial setting where a component's occupational exposure limit may be surpassed, than can be considered hazardous

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