SDS Number 131752 Approved/Revised 03-Apr-2008 Version 1
AXID CAPSULES
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material AXID CAPSULES
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AXID 150 MG CAPSULES * AXID 300 MG CAPSULES * NDC NO. 65726-144-15 * NDC NO.
Synonym(s)
65726-145-10 * NIZATIDINE, FORMULATED PRODUCT
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GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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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
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GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
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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
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Ingredients CAS # Percent EC-No.
NIZATIDINE 76963-41-2 45.9 to 79.6
NON-HAZARDOUS INGREDIENTS Unassigned 28.4 to 54.1
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Exposure might occur via ingestion; skin; eyes.
Health
May produce allergic skin reactions.
Health effects information is based on hazards of components.
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No information is available about the potential of this product to produce adverse
Environment
environmental effects.
4. FIRST-AID MEASURES
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Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the
Ingestion
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.
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Physical form suggests that risk of inhalation exposure is negligible.
Inhalation
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Using appropriate personal protective equipment, remove contaminated clothing and flush
Skin Contact
exposed area with large amounts of water. Obtain medical attention if skin reaction occurs,
which may be immediate or delayed.
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SDS Number 131752 Approved/Revised 03-Apr-2008 Version 1
AXID CAPSULES
Material
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Wash immediately with clean and gently flowing water. Continue for at least 15 minutes.
Eye Contact
Obtain medical attention.
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NOTES TO HEALTH PROFESSIONALS
In allergic individuals, exposure to this material may require treatment for initial or delayed
Medical Treatment
allergic symptoms and signs. This may include immediate and/or delayed treatment of
anaphylactic reactions.
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None for occupational exposure.
Medical Conditions
Caused or Aggravated by
Exposure
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No specific antidotes are recommended.
Antidotes
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5. FIRE-FIGHTING MEASURES
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Not expected for the product, although the packaging is combustible.
Fire and Explosion Hazards
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Water or foam extinguishers are recommended.
Extinguishing Media
Carbon dioxide or dry powder extinguishers may be ineffective.
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For single units (packages): No special requirements needed.
Special Firefighting
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.
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Toxic, corrosive or flammable thermal decomposition products are expected when the
Hazardous Combustion
product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
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Wear protective clothing and equipment consistent with the degree of hazard.
Personal Precautions
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For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage
Environmental Precautions
systems.
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Collect and place it in a suitable, properly labelled container for recovery or disposal.
Clean-up Methods
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No specific decontamination or detoxification procedures have been identified for this
Decontamination Procedures
product.
7. HANDLING AND STORAGE
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HANDLING
Avoid breaking or crushing capsules.
General Requirements
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No storage requirements necessary for occupational hazards. Follow product information
STORAGE
storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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NIZATIDINE
INGREDIENT
3 SKIN SENSITISER, PROVISIONAL
GSK Occupational Hazard
Category
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None required for normal handling. Wash hands and arms thoroughly after handling.
Other Equipment or
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
Capsule.
Physical Form
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SDS Number 131752 Approved/Revised 03-Apr-2008 Version 1
AXID CAPSULES
Material
10. STABILITY AND REACTIVITY
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This product is expected to be stable.
Stability
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None for normal handling of this product.
Conditions to Avoid
11. TOXICOLOGY INFORMATION
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This product contains active ingredient(s) with the following activity: a histamine antagonist
Pharmacological Effects
(H2 sub-type). Adverse effects of overexposure might include: sweating; symptoms of
hypersensitivity (such as skin rash, hives, itching); anaemia.
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No specific target organ effects have been identified.
Target Organ Effects
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Routes of Exposure
Not expected to be toxic following ingestion.
Oral Toxicity
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No studies have been conducted.
Inhalation Toxicity
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No studies have been conducted.
Skin Effects
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No studies have been conducted.
Eye Effects
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Allergic skin reactions might occur following dermal exposure.
Sensitisation
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Not expected to be genotoxic under occupational exposure conditions.
Genetic Toxicity
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No components are listed as carcinogens by GSK, IARC, NTP or US OSHA.
Carcinogenicity
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Not expected to produce adverse effects on fertility or development under occupational
Reproductive Effects
exposure conditions. This material is not considered to be a hazard to the quantity or the
quality of breast milk under occupational exposure conditions.
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None known for occupational exposure.
Other Adverse Effects
12. ECOLOGICAL INFORMATION
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No information is available about the potential of this product to produce adverse
Summary
environmental effects. Local regulations and procedures should be consulted prior to
environmental release.
13. DISPOSAL CONSIDERATIONS
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Collect for recycling or recovery if possible. The disposal method for rejected
Disposal Recommendations
products/returned goods must ensure that they cannot be re-sold or re-used.
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Observe all local and national regulations when disposing of this product.
Regulatory Requirements
14. TRANSPORT INFORMATION
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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.
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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
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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.
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EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product,
cosmetic product or medical device.
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US OSHA Standard (29 CFR Part 1910.1200)
This dosage form is exempt from the requirements of the OSHA Hazard Communication
Classification
Standard.
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SDS Number 131752 Approved/Revised 03-Apr-2008 Version 1
AXID CAPSULES
Material
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Other US Regulations
Exempt
TSCA Status
16. OTHER INFORMATION
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GSK Hazard Determination
References
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1
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
IDENTIFICATION OF SUBSTANCE / PREPARATION AND OF
COMPANY
PHYSICAL AND CHEMICAL PROPERTIES
REGULATORY INFORMATION
TOXICOLOGY INFORMATION
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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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