ATELVIA (Risedronate Sodium) TABLET, DELAYED RELEASEContaining 35 mg Risedronate Sodium

ACTAVIS, INC

Revision date : 2013-11-30

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Note: Ingredients listed on restricted chemical lists

EC/CAS

500-019-9/9005-65-6

Name of the chemical

polyethyleneglycol sorbitan monooleate

Concentration

Proprietary

EC/CAS

232-674-9/9004-34-6

Name of the chemical

cellulose

Concentration

Proprietary

EC/CAS

200-313-4/57-11-4

Name of the chemical

stearic acid

Concentration

Proprietary

EC/CAS

238-877-9/14807-96-6

Name of the chemical

Talc

Concentration

Proprietary

EC/CAS

201-070-7/77-93-0

Name of the chemical

citric acid, triethyl ester

Concentration

Proprietary

EC/CAS

215-168-2

Name of the chemical

Iron Oxide Red

Concentration

Proprietary

EC/CAS

209-150-3

Name of the chemical

Aluminium, zinc, magnesium and calcium stearates

Concentration

Proprietary

General Information

Revision date

2013-11-30

Product name

ATELVIA (Risedronate Sodium) TABLET, DELAYED RELEASEContaining 35 mg Risedronate Sodium

Product Synonyms

35 mg Yellow Oval Tablet NDC 0430-0979-03; NDC 0430-0979-95

supplier name

U.S

Emergency telephone

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

Icons in SDS

Company Information

company name

ACTAVIS, INC

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

SDS@Actavis.com

Section 2

SECTION 2: Hazards identification

Product definition

This product is supplied as yellow, oval tablets

Health hazards

In the workplace, exposure via inhalation or eye contact may cause irritation. No information is available on possible effects from skin exposure. Accidental ingestion may be harmful. In therapeutic use, the most common adverse effects reported include back pain, muscle pain, abdominal pain, and upset stomach. Hypersensitivity reactions and sometimes severe effects on the musculoskeletal system have been reported. May cause harm to the fetus during pregnancy and adverse effects on fertility, based on animal information. Other adverse effects seen from therapeutic use are described in Section 11 (Toxicological information). 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 iron, carbon, magnesium, silicon and nitrogen oxides and hydrogen chloride). Reactivity Hazards: This product is not reactive.

Environmental hazards

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

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