SDS Number 2915 Approved/Revised 12-Dec-2006 Version 15
CONTAC SEVERE COLD AND FLU MAXIMUM STRENGTH CAPLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material CONTAC SEVERE COLD AND FLU MAXIMUM STRENGTH CAPLETS
CONTAC SEVERE COLD AND FLU FORMULA - MAXIMUM STRENGTH
Synonyms
CAPLETS (US) * CONTAC COLD NASAL CONGESTION NIGHTTIME
REGULAR STRENGTH CAPLETS (CANADA) * CONTAC SCF MAXIMUM
STRENGTH CAPLETS * MFC 55011-47-0102 * MMI 4351 * PARACETAMOL,
DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE
HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE, FORMULATED
PRODUCT
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response
GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
2. COMPOSITION / INFORMATION ON INGREDIENTS
Percentage
Ingredients CAS RN
PARACETAMOL 69
103-90-2
DEXTROMETHORPHAN HYDROBROMIDE 2
125-69-9
PSEUDOEPHEDRINE HYDROCHLORIDE 4.2
345-78-8
CHLORPHENIRAMINE MALEATE 0.3
113-92-8
NON-HAZARDOUS INGREDIENTS 24.5
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
* Health Exposure might occur via ingestion; skin; eyes.
Health effects information is based on hazards of components.
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SDS Number 2915 Approved/Revised 12-Dec-2006 Version 15
CONTAC SEVERE COLD AND FLU MAXIMUM STRENGTH CAPLETS
Material
* Environment Harmful to aquatic organisms.
4. FIRST-AID MEASURES
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 Medical treatment in cases of overexposure should be treated as an
overdose of acetaminophen/paracetamol. Treat according to locally
accepted protocols. For additional guidance, refer to the local poison control
information centre.
Medical Conditions None for occupational exposure.
Caused or Aggravated
by Exposure
Antidotes The decision as to whether the severity of poisoning requires administration
of any antidote and actual dose required should be made by qualified
medical personnel. For medical treatment in cases of overexposure, a
recommended antidote would be mucomyst (N-acetylcysteine).
5. FIRE-FIGHTING MEASURES
Fire and Explosion Not expected for the product, although the packaging is combustible.
Hazards
Extinguishing Media Water, dry powder or foam extinguishers are recommended. Carbon
dioxide extinguishers may be ineffective.
Special Firefighting For single units (packages): No special requirements needed. For larger
amounts (multiple packages/pallets) of product: Since toxic, corrosive or
Procedures
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 Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
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 No specific decontamination or detoxification procedures have been
identified for this product.
Procedures
7. HANDLING AND STORAGE
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SDS Number 2915 Approved/Revised 12-Dec-2006 Version 15
CONTAC SEVERE COLD AND FLU MAXIMUM STRENGTH CAPLETS
Material
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
PARACETAMOL
INGREDIENT
1
GSK Occupational
Hazard Category
GSK Occupational 4000 MCG/M3 (8 HR TWA)
Exposure Limit
DEXTROMETHORPHAN HYDROBROMIDE
INGREDIENT
4
GSK Occupational
Hazard Category
GSK Occupational 10 mcg/m3 (8 HR TWA)
Exposure Limit
PSEUDOEPHEDRINE HYDROCHLORIDE
INGREDIENT
2
GSK Occupational
Hazard Category
GSK Occupational 200 mcg/m3 (8 HR TWA)
Exposure Limit
CHLORPHENIRAMINE MALEATE
INGREDIENT
4
GSK Occupational
Hazard Category
GSK Occupational 10 MCG/M3 (8 HR TWA)
Exposure Limit
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields or cover goggles if eye
contact is possible.
Other Equipment or Wash hands and arms thoroughly after handling. None required for normal
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Light blue.
Colour
Tablet.
Physical Form
10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
Conditions to Avoid None for normal handling of this product.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity Adverse effects might occur following ingestion.
Inhalation Toxicity No studies have been conducted.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Irritation might occur following direct contact with eyes.
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SDS Number 2915 Approved/Revised 12-Dec-2006 Version 15
CONTAC SEVERE COLD AND FLU MAXIMUM STRENGTH CAPLETS
Material
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: liver; central nervous system.
Sensitisation Sensitisation (allergic skin reaction) is not expected.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
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.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
* Summary This product contains an active ingredient that has been tested and which
may be harmful if released directly to the environment. 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
Daphnid This mixture contains a major component(s) that is toxic to daphnids.
13. DISPOSAL CONSIDERATIONS
Disposal Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
Recommendations
re-used.
Regulatory Requirements Observe all local and national regulations when disposing of this product.
14. TRANSPORT INFORMATION
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.
UN Classification and Labelling
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
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 Exempt when packaged for sale to consumers in a retail establishment.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
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SDS Number 2915 Approved/Revised 12-Dec-2006 Version 15
CONTAC SEVERE COLD AND FLU MAXIMUM STRENGTH CAPLETS
Material
References GSK Hazard Determination
Date Approved/Revised 12-Dec-2006 SDS Version Number 15
SDS Sections Updated
Sections Subsections
ECOLOGICAL INFORMATION Activated Sludge Respiration
Adsorption
Algal
Algal Degradation
Bioaccumulation
Biodegradation
Crustacea
Daphnid
Distribution
Earthworm
Ecotoxicity
EHAC Notation
Fish
GSK Environmental Hazard Category
Hydrolysis
Microbial Growth Inhibition
Microtox
Mobility
Other Adverse Effects
Other Species - Aquatic
Other Species - Terrestrial
Partitioning
Persistence/Degradation
Photolysis
Solubility
Summary
Volatility
HAZARDS IDENTIFICATION Conditions Aggravated by Exposure
Environment
Eye Contact
Health
Ingestion
Inhalation
Overview
Skin Contact
Summary
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.
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