FAMCICLOVIR TABLETS

WATSON PHARMACEUTICALS, INC

Revision date : 2012-06-05

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

N/A

EC/CAS

9004-65-3

Name of the chemical

methylhydroxypropylcellulose

Concentration

N/A

EC/CAS

200-559-2

Name of the chemical

Lactose C12H22O11

Concentration

0.1%

General Information

Revision date

2012-06-05

Product name

FAMCICLOVIR TABLETS

Product Synonyms

NDC 0591-3271-30, 0591-3272-30, 0591-3273-30

Chemical name

2-[2-(-Amino-9H-purin-9-yl)ethyl]-1,3-propanediol Diacetate

Emergency telephone

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

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Company Information

company name

WATSON PHARMACEUTICALS, INC

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

Robert.McCafferty@Watson.com

GHS Information

Signal word

Not Applicable

Section 2

SECTION 2: Hazards identification

Signal word

Not Applicable

Hazard statements

Not Applicable EU LABELING AND CLASSIFICATION 67/548/EEC: According to Article 1 of European Union Council Directive 92/32/EEC, medical products in the finished state for human use (as defined by European Union Council Directives 67/548/EEC and 87/21/EEC) are not subject to the regulations and administrative provisions of European Union Council Directive 92/32/EEC. Not Applicable Not Applicable

Precautionary statements

Not Applicable See Section 16 for full EU classification information of product and components and full text of hazard and precautionary statements. EMERGENCY OVERVIEW

Product definition

This product is supplied as white, round (125 mg and 250 mg) tablets and white, oval (500 mg) caplets.

Health hazards

The chief health hazard associated with overexposures during normal use and handling is the potential for irritation of contaminated skin. Individuals who have had allergic reactions to products containing Famciclovir, penciclovir, or any of the other ingredients in this product may experience allergic reactions to this product. Therapeutic use of Famciclovir can cause adverse symptoms on the renal and central nervous systems. Flammability Hazards: If heated to high temperatures for a prolonged period, the product may ignite. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon oxides, nitrogen oxides, and sodium oxides). Reactivity Hazards: This product is not reactive.

Environmental hazards

Large quantities released to the aquatic and terrestrial environment may have an adverse effect. Emergency Considerations: Emergency responders should wear appropriate protection for situation to which they respond.

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