ENABLEX (Darifenacin) TABLET, EXTENDED RELEASEContaining 7.5 or 15 mg Darifenacin Hydrobromide

U.S

Revision date : 2015-11-29

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

9004-65-3

Name of the chemical

methylhydroxypropylcellulose

Concentration

Proprietary

EC/CAS

238-877-9/14807-96-6

Name of the chemical

Talc

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

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

2015-11-29

Product name

ENABLEX (Darifenacin) TABLET, EXTENDED RELEASEContaining 7.5 or 15 mg Darifenacin Hydrobromide

Product Synonyms

mg Round White Tablets NDC 0430-0170-15; NDC 0430-0170-23; NDC 0430-0170-96; mg Round Peach Tablet NDC 0430-0171-15; NDC 0430-0171-23; NDC 0430-0171-96

supplier name

U.S

Emergency telephone

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

Icons in SDS

Company Information

company name

U.S

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

SDS@Allergan.com

Section 2

SECTION 2: Hazards identification

Product definition

This product is supplied as round tablets which are white or red

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 constipation, dry mouth, headache, heartburn, nausea, urinary tract infection, blurred vision, heat exhaustion or heat-stroke. Somnolence has also been reported. May cause harm to the fetus during pregnancy, 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, titanium, carbon, magnesium, and nitrogen oxides and hydrogen bromide). Reactivity Hazards: This product is not reactive.

Environmental hazards

The active ingredient can cause long-term harm to algae and other aquatic organisms 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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