ACETAMINOPHEN and CODEINE PHOSPHATE TABLET

SECTION 2: Hazards identification

1272/2008 GLOBAL HARMONIZATION AND EU CLP REGULATION (EC) 1272/2008 LABELING AND CLASSIFICATION: According to Article 1, item 5 (a) of CLP Regulation (EC) 1272/2008, medicinal products in the finished state for human use, as defined in 2001/83/EC, are excepted from classification and other criteria of 1272/2008. EU LABELING/CLASSIFICATION: 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. EMERGENCY OVERVIEW: This product is a DEA Schedule C, Category III drug and must be handled, dispensed and stored per DEA regulations. Product Description This product is supplied as round light red tablets.

Health hazards

In the workplace, exposure of dusts from product via inhalation and skin contact may cause irritation. Eye contact with dusts can cause mechanical irritation. In therapeutic use, the most common adverse effects reported include lightheadedness, dizziness, sedation, nausea, general unease or feeling of being unwell, constipation and itching and vomiting. Serious, life-threatening, or fatal respiratory depression may occur with use of this material therapeutically. Serious, potentially life-threatening allergic reactions have been reported. Depression of the respiratory system may be long-lasting, especially in individuals not normally exposed to opioids. This material is a narcotic and so presents a hazard of chemical dependence. Limited evidence of harm to fetus during pregnancy, based on animal data. May cause harm to breast-fed infants. 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: This product requires substantial pre-heating before ignition occurs. When involved in a fire, this product may decompose and produce irritating vapors and toxic compounds (including carbon and nitrogen oxides). Reactivity Hazards: This product is not reactive.

Environmental hazards

Release to the aquatic and terrestrial environment may have an adverse effect. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.