RISEDRONATE SODIUM TABLET FILM-COATED

ACTAVIS, INC

Revision date : 2015-08-08

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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

Proprietary

EC/CAS

9004-64-2

Name of the chemical

hydroxypropylcellulose

Concentration

Proprietary

EC/CAS

9004-65-3

Name of the chemical

methylhydroxypropylcellulose

Concentration

Proprietary

EC/CAS

232-674-9/9004-34-6

Name of the chemical

cellulose

Concentration

Proprietary

EC/CAS

500-038-2/25322-68-3

Name of the chemical

polyethyleneglycol

Concentration

Proprietary

EC/CAS

236-675-5/13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

Proprietary

EC/CAS

200-559-2

Name of the chemical

Lactose C12H22O11

Concentration

Proprietary

EC/CAS

209-150-3

Name of the chemical

Aluminium, zinc, magnesium and calcium stearates

Concentration

Proprietary

General Information

Revision date

2015-08-08

Product name

RISEDRONATE SODIUM TABLET FILM-COATED

Product Synonyms

mg 30 count NDC 0591-2102-30; 30 mg 30 count NDC 0591-2109-30; 35 mg, 4 count (1 per week) NDC 0591-2075-04; 12 count (1 per week) NDC 0591-2075-39;

Chemical name

For Active Ingredients

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 oval tablets which are yellow (5 mg), white (30 mg), orange (35 mg), pink (75 mg) or blue (150 mg).

Health hazards

Accidental ingestion may be harmful. In therapeutic use, the most common adverse effects reported have been back pain, joint pain, abdominal pain, and upset stomach. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation have been reported rarely. May cause harm to fetus, based on animal information. These effects may be possible as a result of workplace exposure. Refer to Section 11 (Toxicological Information) for additional information on adverse effects. 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, titanium, carbon, magnesium, silicon and nitrogen oxides and hydrogen chloride). 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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