4360
RELIFEX TABLETS
Approved/Revised 17-Dec-2004
Material
SDS Number Version 11
RELIFEX TABLETS Material
Synonyms FLAMBATE TABLETS * MEBUTAN TABLETS * BALMOX TABLETS *
RELIFEX TABLETS 400 MG * RELIFEX TABLETS 500 MG * RELIFEX
TABLETS 750 MG * RELIFEX TABLETS 1000 MG * RELAFEN TABLETS *
NDC NO 0029-4851-20 * NDC NO 0029-4851-21 * NDC NO 0029-4852-20 *
NABUMETONE, FORMULATED PRODUCT
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
2200 Renaissance Blvd, Suite 105
GlaxoSmithKline, Corporate Environment, Health & Safety
King of Prussia, PA 19406 US
Percentage CAS RN Ingredients
78.9 42924-53-8 NABUMETONE
21.1 Unassigned NON-HAZARDOUS INGREDIENTS
Fire and Explosion Expected to be non-combustible.
Health Exposure might occur via skin; eyes; ingestion.
Caution - Pharmaceutical agent. Possible effects of overexposure in the
workplace include: irritation; coughing; increased mucous secretion;
headache; nausea; dizziness; sedation. Health effects information is based
on hazards of components. Handling this product in its final form presents
minimal risk from occupational exposure.
Environment Dangerous for the environment. Very toxic to aquatic organisms.
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
2. COMPOSITION / INFORMATION ON INGREDIENTS
3. HAZARDS IDENTIFICATION
4. FIRST-AID MEASURES
Page 1 / 6
4360
RELIFEX TABLETS
Approved/Revised 17-Dec-2004
Material
SDS Number Version 11
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 Physical form suggests that risk of inhalation exposure is negligible.
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 local poison control information centre. Medical treatment in cases of
overexposure should be treated as an overdose of an anti-inflammatory.
Medical Conditions
Caused or Aggravated
by Exposure
None for occupational exposure.
Antidotes No specific antidotes are recommended.
Fire and Explosion
Hazards
Not expected for the product, although 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.
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 Prevent entry into waterways, sewers, surface drainage systems and poorly
ventilated areas.
Clean-up Methods Spread an inert absorbent on the spill and place in a suitable, properly
labelled container for recovery or disposal.
Decontamination
Procedures
No specific decontamination or detoxification procedures have been
identified for this product.
HANDLING
General Requirements Avoid breaking or crushing tablets.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
5. FIRE-FIGHTING MEASURES
6. ACCIDENTAL RELEASE MEASURES
7. HANDLING AND STORAGE
Page 2 / 6
4360
RELIFEX TABLETS
Approved/Revised 17-Dec-2004
Material
SDS Number Version 11
INGREDIENT NABUMETONE
GSK Occupational
Hazard Category
1
GSK Occupational
Exposure Limit
1000 MCG/M3 (8 HR TWA)
Other Equipment or
Procedures
Wash hands and arms thoroughly after handling. None required for normal
handling.
Appearance
Colour
Physical Form
Dark red.
Film-coated tablet.
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.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Irritation is not expected following direct contact with eyes.
Target Organ Effects No specific target organ effects have been identified.
Sensitisation Sensitisation (allergic skin reaction) is not expected.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Carcinogenicity 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.
Pharmacological Effects This preparation contains ingredient(s) with the following activity: a
non-steroidal anti-inflammatory substance.
Adverse effects of overexposure might include: irritation; coughing;
increased mucous secretion; headache; nausea; dizziness; sedation.
Other Adverse Effects None known for occupational exposure.
* Summary This material contains an active pharmaceutical ingredient that has been
tested, and which may be very toxic to aquatic organisms if released
directly to the environment. Consult the MSDS of the active ingredient for
specific information about potential environmental effects. Appropriate
precautions should be taken to limit release of this mixture to the
environment. Local regulations and procedures should be consulted prior to
environmental release.
Specific information on the active pharmaceutical ingredient is provided
below.
ECOTOXICITY
Aquatic
9. PHYSICAL AND CHEMICAL PROPERTIES
10. STABILITY AND REACTIVITY
12. ECOLOGICAL INFORMATION
Page 3 / 6
4360
RELIFEX TABLETS
Approved/Revised 17-Dec-2004
Material
SDS Number Version 11
Activated Sludge
Respiration
IC50: > 10 mg/L, 3 Hours, Residential sludge
No toxicity to sludge microorganisms was observed for the active
pharmaceutical ingredient in this mixture, but the upper range of the test
was limited by the low water solubility of the compound.
Microtox Microtox is a general toxicity test which utilizes a sensitive marine photo
bacteria as the test species. This material contains an active
pharmaceutical ingredient that is toxic to these microorganisms.
EC50: 0.4 mg/L, 15 Minutes
* Algal
IC50: 0.68 mg/L, 96 Hours, Selenastrum capricornutum,
green algae, Static test
This material contains an active pharmaceutical ingredient that is very toxic
to algae.
* Daphnid
EC50: 3.5 mg/L, 48 Hours, Daphnia magna, Static test
NOEL: 1.1 mg/L, 48 Hours, Daphnia magna, Static test
This material contains an active pharmaceutical ingredient that is toxic to
daphids.
Fish
Adult Lepomis macrochirus, bluegill sunfish
EC50: > 4.4 mg/L, 96 Hours, Static test
Adult Lepomis macrochirus, bluegill sunfish
NOEL: 1.4 mg/L, 96 Hours, Static test
No toxicity to fish was observed for the active pharmaceutical ingredient,
but the upper range of the test was limited by the low water solubility of the
compound.
MOBILITY
* Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has very low solubility in water.
Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into air from water.
Henry's Law Constant < 1.00E-05 atm m^3/mol, Measured
* Adsorption
2.9, Calculated Soil Sediment Sorption
(log Koc):
1.62 Measured Sludge Biomass
Distribution Coefficient
(log Kd):
This material contains an active pharmaceutical ingredient that is not likely
to adsorb to sludge or biomass if released directly to the environment. This
material contains an active pharmaceutical ingredient that is not likely to
adsorb to soil or sediment if released directly to the environment.
* 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 may have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
Photolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water when exposed to light. Aqueous
photolysis may be a significant depletion mechanism.
Half-Life, Aqueous: 58 Hours, Measured, Deionized Water
Page 4 / 6
4360
RELIFEX TABLETS
Approved/Revised 17-Dec-2004
Material
SDS Number Version 11
* 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: 50 %, 2.1 hours, Batch activated sludge (BAS),
Activated sludge
* BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
82 Calculated Bioconcentration Factor:
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.
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
16. OTHER INFORMATION
References GSK Hazard Determination
17-Dec-2004 Date Approved/Revised 11 SDS Version Number
SDS Sections Updated
Sections Subsections
ECOLOGICAL INFORMATION
Activated Sludge Respiration
Adsorption
Algal
Bioaccumulation
Biodegradation
Page 5 / 6
4360
RELIFEX TABLETS
Approved/Revised 17-Dec-2004
Material
SDS Number Version 11
SDS Sections Updated
Sections Subsections
Daphnid ECOLOGICAL INFORMATION
Fish
Microtox
Partitioning
Photolysis
Solubility
Summary
Volatility
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.
Page 6 / 6