Microzide

Allergan plc

Revision date : 2019-07-16

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

Note: Ingredients listed on restricted chemical lists

EC/CAS

9005-25-8

Name of the chemical

Starch

Concentration

N/A

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

N/A

EC/CAS

14807-96-6

Name of the chemical

Talc

Concentration

N/A

EC/CAS

112-80-1

Name of the chemical

oleic acid

Concentration

N/A

EC/CAS

232-679-6

Name of the chemical

Starch

Concentration

N/A

EC/CAS

238-877-9

Name of the chemical

Talc: Hydrated magnesium silicate

Concentration

N/A

General Information

Revision date

2019-07-16

Product name

Microzide

Product Synonyms

Hydrochlorothiazide Capsules

Manufacturer Name

Allergan plc

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)

H351, H362

Hazard statements

Code

Statements

H351

Suspected of causing cancer

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) Carcinogenicity Category 2 Effects on or via lactation Yes

2.2 Label elements

Emergency Overview Warning

Hazard statements

H351 - Suspected of causing cancer H362 - May cause harm to breast-fed children Appearance Capsule Physical state Solid Odor No information available Chemical Name Symptoms HYDROCHLOROTHIAZIDE The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity: weakness, hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs), pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia, aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia, anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura, electrolyte imbalance, hyperglycemia, glycosuria, hyperuricemia, muscle spasm, vertigo, paresthesias, dizziness, headache, restlessness, renal failure, renal dysfunction, interstitial nephritis, erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia, transient blurred vision, xanthopsia, impotence. Trospium Chloride The most common adverse reactions are dry mouth, constipation, and headache. Donepezil HCL The most common symptoms seen in therapeutic use include: nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue and anorexia. POVIDONE USP(PLASDONE K-29-32) Possible eye, skin, gastrointestinal and/or respiratory tract irritation. Possible allergic reaction to material if inhaled, ingested or in contact with skin. Overdose effects from ingestion of large amounts include abdominal cramps, flatulence, and fecal impaction. Memantine Hydrochloride Most common are dizziness, headache, confusion and constipation Chemical Name

Medical Conditions Generally Aggravated by Exposure

HYDROCHLOROTHIAZIDE Anuria. Known hypersensitivity to this product or to other sulfonamide-derived drugs. Trospium Chloride This medication is contraindicated in patients with: urinary retention, gastric retention , uncontrolled narrow-angle glaucoma, known hypersensitivity to the drug or its ingredients; angioedema, rash and anaphylactic reaction have been reported. Donepezil HCL When administered for therapeutic use, pre-existing asthma,ulcers, cardiac abnormalities, hepatic, bladder and neurological conditions may be aggravated by exposure POVIDONE USP(PLASDONE K-29-32) Known hypersensitivity to this medication Memantine Hydrochloride Contraindication include hypersensitivity to any component of this product hepatic impairment

Precautionary statements

P202 - Do not handle until all safety precautions have been read and understood P281 - Use personal protective equipment as required P405 - Store locked up P501 - Dispose of contents/ container to an approved waste disposal plant P201 - Obtain special instructions before use P260 - Do not breathe dusts or mists P263 - Avoid contact during pregnancy/while nursing P264 - Wash face, hands and any exposed skin thoroughly after handling P270 - Do not eat, drink or smoke when using this product P308 + P313 - IF exposed or concerned: Get medical advice/attention

Further information

Unknown Acute Toxicity 2.15% 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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