AUGMENTIN 4:1 ORAL SUSPENSION 2145 Approved/Revised 03-Jan-2006 Material SDS Number Version 15 GlaxoSmithKline, Corporate Environment, Health & Safety Company Name 980 Great West Road +44-20-8047-5000 UK General Information: +44-1865-407333 Transport Emergency (EU) +1-612-221-3999, Ext 221 Medical Emergency US number, available 24 hours Information and Advice: Multi-language response Brentford, Middlesex TW8 9GS UK +1-888-825-5249 US General Information: +1-703-527-3887 Transport Emergency (non EU) US number, available 24 hours Multi-language response One Franklin Plaza, 200 N 16th Street GlaxoSmithKline, Corporate Environment, Health & Safety Philadelphia, PA 19102-1225 US Percentage CAS RN Ingredients 14.5 to 22.2 61336-70-7 AMOXICILLIN TRIHYDRATE 3.6 to 5.6 61177-45-5 POTASSIUM CLAVULANATE 72.2 to 81.9 Unassigned NON-HAZARDOUS INGREDIENTS Fire and Explosion Assume that this product is capable of sustaining combustion. SAFETY DATA SHEET 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING 2. COMPOSITION / INFORMATION ON INGREDIENTS 3. HAZARDS IDENTIFICATION Synonyms AUGMENTIN 125 MG/5 ML SUSPENSION * AUGMENTIN 156.25 MG/5 ML SUSPENSION * AUGMENTIN 250 MG/5 ML SUSPENSION * AUGMENTIN 312.5 MG/5 ML SUSPENSION * CLAVULIN-125F SUSPENSION * CLAVULIN-250F SUSPENSION * CLAMOXYL SUSPENSION 125 MG * CLAMOXYL SUSPENSION 250 MG * NDC NO. 0029-6085-22 * NDC NO. 0029-6085-23 * NDC NO. 0029-6085-39 * NDC NO. 0029-6090-22 * NDC NO. 0029-6090-23 * NDC NO. 0029-6090-39 * AMOXYCILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE, FORMULATED PRODUCT Material AUGMENTIN 4:1 ORAL SUSPENSION Page 1 / 6 AUGMENTIN 4:1 ORAL SUSPENSION 2145 Approved/Revised 03-Jan-2006 Material SDS Number Version 15 Health Exposure might occur via skin; eyes; ingestion; inhalation. May produce allergic skin reactions. Respiratory allergen. Possible effects of overexposure in the workplace include: symptoms of hypersensitivity (such as skin rash, hives, itching, and difficulty breathing); nausea; vomiting; diarrhoea. Health effects information is based on hazards of components. Environment No information is available about the potential of this product to produce adverse environmental effects. Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention. Inhalation Using appropriate personal protective equipment, move exposed subject to fresh air. If breathing is difficult or ceases, ensure and maintain ventilation. Give oxygen as appropriate. The exposed subject should be kept warm and at rest. Obtain medical attention in cases of known or possible over exposure, or with symptoms including chest pain, difficulty breathing, loss of consciousness or other adverse effects, which may be delayed. Skin Contact Using appropriate personal protective equipment, remove contaminated clothing and flush exposed area with large amounts of water. Obtain medical attention if skin reaction occurs, which may be immediate or delayed. Eye Contact Wash immediately with clean and gently flowing water. Continue for at least 15 minutes. Obtain medical attention. NOTES TO HEALTH PROFESSIONALS Medical Treatment Treat according to locally accepted protocols. For additional guidance, refer to the current prescribing information or to the local poison control information centre. Medical treatment in cases of overexposure should be treated as an overdose of penicillin antibiotic. In allergic individuals, exposure to this material may require treatment for initial or delayed allergic symptoms and signs. This may include immediate and/or delayed treatment of anaphylactic reactions. Medical Conditions Caused or Aggravated by Exposure Refer to prescribing information for detailed description of medical conditions caused by or aggravated by overexposure to this product. Ocular symptoms may be indicative of allergic reaction. Pulmonary symptoms may indicate allergic reaction or asthma. This material may cause or aggravate allergy to penicillin antibiotics. Antidotes No specific antidotes are recommended. Fire and Explosion Hazards The combustibility of the product is not known, however the packaging is combustible. Extinguishing Media Water, dry powder or foam extinguishers are recommended. Carbon dioxide extinguishers may be ineffective. Special Firefighting Procedures For single units (packages): No special requirements needed. For larger amounts (multiple packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved from fires involving this product and associated packaging, self contained breathing apparatus and full protective equipment are recommended for firefighters. If possible, contain and collect firefighting water for later disposal. 4. FIRST-AID MEASURES 5. FIRE-FIGHTING MEASURES Page 2 / 6 AUGMENTIN 4:1 ORAL SUSPENSION 2145 Approved/Revised 03-Jan-2006 Material SDS Number Version 15 Hazardous Combustion Products Toxic, corrosive or flammable thermal decomposition products are expected when the product is exposed to fire. Personal Precautions Wear protective clothing and equipment consistent with the degree of hazard. Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage systems. Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or disposal. Decontamination Procedures No specific decontamination or detoxification procedures have been identified for this product. Water can be used for clean-up and decontamination operations. HANDLING General Requirements No special control measures required for the normal handling of this product. Normal room ventilation is expected to be adequate for routine handling of this product. STORAGE No storage requirements necessary for occupational hazards. Follow product information storage instructions to maintain efficacy. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION INGREDIENT AMOXICILLIN TRIHYDRATE GSK Occupational Hazard Category 3 GSK Occupational Exposure Limit 100 MCG/M3 (15 MIN STEL) RESPIRATORY SENSITISER, SKIN SENSITISER INGREDIENT POTASSIUM CLAVULANATE GSK Occupational Hazard Category 1 GSK Occupational Exposure Limit 5000 MCG/M3 (8 HR TWA) 6. ACCIDENTAL RELEASE MEASURES 7. HANDLING AND STORAGE ENGINEERING CONTROLS Exposure Controls An Exposure Control Approach (ECA) is established for operations involving this material based upon the OEL/Occupational Hazard Category and the outcome of a site- or operation-specific risk assessment. Refer to the Exposure Control Matrix for more information about how ECA's are assigned and how to interpret them. PERSONAL PROTECTIVE EQUIPMENT Eye Protection Wear approved safety glasses with side shields if eye contact is possible. Respirators If respiratory protective equipment (RPE) is used, the type of RPE will depend upon air concentrations present, required protection factor as well as hazards, physical properties and warning properties of substances present. Other Equipment or Procedures Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after handling. * Occupational Hygiene Air Monitoring Methods For advice on suitable monitoring methods, seek guidance from a qualified environment, health and safety professional. Page 3 / 6 AUGMENTIN 4:1 ORAL SUSPENSION 2145 Approved/Revised 03-Jan-2006 Material SDS Number Version 15 Appearance Physical Form Powder. 9. PHYSICAL AND CHEMICAL PROPERTIES Stability This product is expected to be stable. Conditions to Avoid None for normal handling of this product. 11. TOXICOLOGICAL INFORMATION Oral Toxicity Not expected to be toxic following ingestion. Inhalation Toxicity Adverse effects might occur following inhalation. Skin Effects Irritation might occur following direct contact. Eye Effects Minor irritation might occur following direct contact with eyes. Target Organ Effects No specific target organ effects have been identified. Sensitisation Allergic skin reactions might occur following dermal exposure. Assessment based upon effects of structurally similar substances. Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions. Assessment based upon effects of structurally similar substances. Carcinogenicity Not expected to produce cancer in humans under occupational exposure conditions. No components are listed as carcinogens by GSK, IARC, NTP or US OSHA. Reproductive Effects Not expected to produce adverse effects on fertility or development under occupational exposure conditions. No adverse effects have been reported following extensive use or exposure in humans. Pharmacological Effects This material is a penicillin; an antibiotic. Summary This material contains two or more active pharmaceutical ingredients that have been tested, one of which may be harmful if released directly to the environment. Specific information on that active pharmaceutical ingredient is provided below. Consult the MSDS of the active ingredient for specific information about potential environmental effects. Appropriate precautions should be taken to limit release of this material to the environment. Local regulations and procedures should be consulted prior to environmental release. ECOTOXICITY Aquatic Algal IC50: 56 mg/L, 72 Hours, Selenastrum capricornutum, green algae NOEL: 9.4 mg/L, 72 Hours, Selenastrum capricornutum, green algae This material contains an active pharmaceutical ingredient that is harmful to algae. * Daphnid EC50: 1610 mg/L, 48 Hours, Daphnia magna, Static test NOEL: 530 mg/L, 48 Hours, Daphnia magna, Static test This material contains an active pharmaceutical ingredient that is not toxic to daphnids. 10. STABILITY AND REACTIVITY 12. ECOLOGICAL INFORMATION Page 4 / 6 AUGMENTIN 4:1 ORAL SUSPENSION 2145 Approved/Revised 03-Jan-2006 Material SDS Number Version 15 Fish Adult Lepomis macrochirus, bluegill sunfish EC50: > 790 mg/L, 96 Hours, Static test Adult Lepomis macrochirus, bluegill sunfish NOEL: 790 mg/L, 96 Hours, Static test Adult Oncorhyncus mykiss, rainbow trout EC50: > 960 mg/L, 96 Hours, Static test Adult Oncorhyncus mykiss, rainbow trout NOEL: 960 mg/L, 96 Hours, Static test This material contains an active pharmaceutical ingredient that is not toxic to fish. MOBILITY Solubility This material contains an active pharmaceutical ingredient that for environmental fate predictions has solubility in water. Partitioning This material contains an active pharmaceutical ingredient with octanol/water partition coefficient data that suggests that for environmental fate predictions the active pharmaceutical ingredient will not have the tendency to distribute into fats. Biodegradation This material contains an active pharmaceutical ingredient that is not readily biodegradable but is inherently biodegradable (as defined by 1993 OECD Testing Guidelines) and is not expected to persist in the environment. Aerobic - Inherent Percent Degradation: 90 %, 28 days, Zahn-Wellens, Activated sludge BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have a tendency to bioaccumulate in the food chain. PERSISTENCE/DEGRADATION Hydrolysis This material contains an active pharmaceutical ingredient that has been shown to be chemically unstable in water. Hydrolysis may be a significant depletion mechanism. Half-Life, Neutral: 28.3 Hours, Measured Half-Life, Basic: 9.92 Hours, Measured Half-Life, Acidic: 11.9 Hours, Measured Disposal Recommendations Collect for recycling or recovery if possible. The disposal method for rejected products/returned goods must ensure that they cannot be re-sold or re-used. Regulatory Requirements Observe all local and national regulations when disposing of this product. The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons trained and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous goods for transport. 14. TRANSPORT INFORMATION 13. DISPOSAL CONSIDERATIONS UN Classification and Labelling Transport Information Transportation and shipping of this product is not restricted. It has no known, significant hazards requiring special packaging or labelling for air, maritime, US or European ground transport purposes. 15. REGULATORY INFORMATION The information included below is an overview of the major regulatory requirements. It should not be considered to be an exhaustive summary. Local regulations should be consulted for additional requirements. Page 5 / 6 AUGMENTIN 4:1 ORAL SUSPENSION 2145 Approved/Revised 03-Jan-2006 Material SDS Number Version 15 16. OTHER INFORMATION References GSK Hazard Determination 03-Jan-2006 Date Approved/Revised 15 SDS Version Number SDS Sections Updated Sections Subsections IDENTIFICATION OF SUBSTANCE / PREPARATION AND OF COMPANY US Environmental (EPA) Requirements REGULATORY INFORMATION The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate as of the date of issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the responsibility of the user to determine the applicability of this information and the suitability of the material or product for any particular purpose. EU Classification and Labelling Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product, cosmetic product or medical device. US OSHA Standard (29 CFR Part 1910.1200) Classification This dosage form is exempt from the requirements of the OSHA Hazard Communication Standard. Other US Regulations TSCA Status Exempt Page 6 / 6