MATERIAL SAFETY DATA SHEET Product Name: Diphenhydramine Hydrochloride Injection, USP 1. CHEMICAL PRODUCT AND COMPANY INFORMATION Manufacturer Name And Address Emergency Telephone Hospira, Inc. Product Name
Synonyms 2. COMPOSITION/INFORMATION ON INGREDIENTS Ingredient Name Diphenhydramine Chemical Formula Approximate Percent Component CAS Number RTECS Number by Weight
3. HAZARD INFORMATION Emergency Overview
Diphenhydramine hydrochloride is an antihistamine used for relief of symptoms associated with allergies or colds, and for the treatment of symptoms associated with motion sickness. Toxic by ingestion. May cause nervous system effects.
Occupational Exposure
Information from occupational exposure is not available.
Signs and Symptoms
The most frequently observed side effects include sedation, sleepiness, breathing difficulty, disturbed coordination, hypotension, gastrointestinal upset and thickened bronchial secretions.
Medical Conditions
Clinical experience suggests narrow-angle glaucoma, peptic ulcers and other
Aggravated by Exposure
gastrointestinal disorders, bladder obstruction, prostatic hypertrophy, asthma, hyperthyroid, cardiovascular disease, hypertension and concurrent use of central nervous system depressants or monoamine oxidase inhibitor therapy.
4. FIRST AID MEASURES Eye Contact:
Remove from source of exposure. Flush with copious amounts of water. If irritation persists or signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary.
Product Name: Diphenhydramine Hydrochloride Injection, USP Skin Contact:
Remove from source of exposure. Flush with copious amounts of water. If irritation persists or signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary.
Inhalation:
Remove from source of exposure. If signs of toxicity occur, seek medical attention. Provide symptomatic / supportive care as necessary.
Ingestion:
Remove from source of exposure. If signs of toxicity occur, seek medical attention. Provide symptomatic / supportive care as necessary.
5. FIRE FIGHTING MEASURES Flammability: Non-flammable Fire & Explosion
Extinguishing Media:
Use extinguishing media appropriate for primary cause of fire.
Special Fire Fighting
No special provisions required beyond normal fire fighting equipment such
Procedures
as flame and chemical resistant clothing and self contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES Spill Cleanup and Disposal
Absorb with suitable material and dispose of materials according to applicable federal, state, or local regulations.
7. HANDLING AND STORAGE Handling
No special storage required for hazard control. For product protection store at
Special Precautions 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Exposure Guidelines Exposure limits Component OSHA-PEL ACGIH-TLV
Notes: OSHA PEL: US Occupational Safety and Health Administration – Permissible Exposure Limit
ACGIH TLV: American Conference of Governmental Industrial Hygienists – Threshold Limit Value. EEL: Employee Exposure Limit.
STEL: 15-minute Short Term Exposure Limit.
Respiratory Protection
Respiratory protection is not needed during normal product use.
Skin Protection
If contact with unprotected skin is likely, glove use is prudent practice.
Product Name: Diphenhydramine Hydrochloride Injection, USP Eye Protection
Eye protection is not required during expected product use conditions but may be warranted if eye contact is likely.
Engineering Controls
Engineering controls are not needed during normal product use conditions.
9. PHYSICAL/CHEMICAL PROPERTIES Appearance/Physical State Odor Boiling Point
Approximately that of water (100o C, 212o F)
Freezing Point Vapor Pressure
Approximately that of water (17.5 mm Hg at 20o C)
Vapor Density (Air=1) Evaporation Rate Not Bulk Density Density 1.005 Solubility
10. STABILITY AND REACTIVITY Chemical Stability
Stable under standard use and storage conditions.
Incompatibilities
Ingredient(s) Percent Type Value
LD50 is the dosage producing 50% mortality. Product contains approximately 5% Diphenhydramine. Mutagenicity Not
Reproductive Effects
Target Organ Effects
Possible target organs include skin, eyes, and the central nervous, gastrointestinal, and cardiovascular systems. In animal studies, there is limited evidence of fetotoxicity and possible cleft palate formation.
12. ECOLOGICAL INFORMATION: Aquatic Toxicity Product Name: Diphenhydramine Hydrochloride Injection, USP 13. DISPOSAL CONSIDERATIONS: Waste Disposal
Disposal should be performed in accordance with the federal, state or local regulatory requirements.
Container Handling
Dispose of container and unused contents in accordance with federal, state,
and Disposal
14. TRANSPORTATION INFORMATION DOT
DOT - US Department of Transportation Regulations
15. REGULATORY INFORMATION TSCA Status CERCLA Status SARA Status RCRA Status PROP 65 (Calif.) Not
TSCA Toxic Substance Control Act CERCLA, US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act SARA Superfund Amendments and Reauthorization Act RCRA US EPA, Resource Conservation and Recovery Act Prop 65, California Proposition 65
16. OTHER INFORMATION:
MSDS Coordinator
Disclaimer: The information and recommendations contained herein are based upon tests believed to be reliable. However, Hospira does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE. Adjustment to conform to actual conditions of usage may be required. Hospira assumes no responsibility for results obtained or for incidental or consequential damages, including lost profits, arising from the use of these data. No warranty against infringement of any patent, copyright or trademark is made or implied.
Level One – Includes low-cost generic and brand-name drugs. Level Two – Includes higher cost generic and brand-name drugs. Level Three – Includes high-cost, mostly brand-name drugs and some self-administered injectables. These drugs may have generic or brand-name alternatives in Levels One or Two. Level Four – Includes high technology drugs and self-administered injectable drug