MATERIAL SAFETY DATA SHEET



                     HYDROMORPHONE, HCl 3mg SUPPOSITORIES

PADDOCK LABORATORIES, INC.                         EMERGENCY ASSISTANCE:

3940 QUEBEC AVENUE NORTH                       CHEMTREC      800-424-9300

MINNEAPOLIS, MINNESOTA 55427                                       202-483-7616

PHONE: (763)-546-4676                              PADDOCK TECH. ASST. 800-328-5113



Date prepared: February 15, 1996       By: Matthew Greuel



           SECTION 1 - PRODUCT IDENTIFICATION AND HAZARDOUS COMPONENTS



PRODUCT NAME:          Hydromorphone HCl, 3 mg Suppositories



SYNONYMS: N/A



MOLECULAR FORMULA: Mixture                     MOLECULAR WEIGHT: N/A



CHEMICAL NAME:           N/A CHEMICAL FAMILY: Narcotic analgesic (CII)



INGREDIENT (CAS NUMBER)                     %        OSHA PEL         ACGIH TLV

Hydromorphone HCl (71-68-1)                < 0.2       N/A               N/A

Cocoa Butter (8002-31-1)                   > 98         N/A              N/A



Other ingredients not listed above are considered not hazardous and are present at a concentration of less than 5%.



                     SECTION 2 - PHYSICAL AND CHEMICAL CHARACTERISTICS



BOILING POINT:         N/A                             VAPOR PRESSURE: N/A



                       30 - 360 C

MELTING POINT:                                                 VAPOR DENSITY:           N/A



SPECIFIC GRAVITY: 0.86                                        EVAPORATION RATE: N/A

(WATER = 1)                                              (BUTYL ACETATE = 1)



WATER SOLUBILITY:              Insoluble                       WATER REACTIVE: No



APPEARANCE AND ODOR: Cream colored, opaque, waxy, torpedo-shaped suppositories; odorless.

MSDS - Hydromorphone HCl 3mg Suppositories                                                             Page 2 of 5

                                SECTION 3 - FIRE AND EXPLOSION DATA



FLASH POINT (METHOD): N/A                          NFPA RATING: N/A



AUTOIGNITION TEMPERATURE: N/A



FLAMMABLE LIMITS: LOWER: N/A                     UPPER: N/A



EXTINGUISHING MEDIA: Water spray, carbon dioxide, dry chemical, or foam as appropriate for surrounding fire

conditions and materials. Class BC, ABC fire extinguishers



SPECIAL FIRE FIGHTING PROCEDURES: Fire fighters should wear full protective gear including self-contained

breathing apparatus.



UNUSUAL FIRE AND EXPLOSION HAZARDS: When heated to decomposition material emits toxic fumes of

NOx and HCl. Emits toxic fumes under fire conditions.



                                SECTION 4 - REACTIVITY HAZARD DATA



STABILITY: Stable ( X ) Unstable ( )



INCOMPATIBILITY (MATERIALS TO AVOID): Oxidizing agents, and heavy metal salts



HAZARDOUS DECOMPOSITION PRODUCTS: Produces toxic fumes ( NOx and HCl ) when heated to

decomposition.



HAZARDOUS POLYMERIZATION: May Occur ( ) Will Not Occur ( X )



                                   SECTION 5 - HEALTH HAZARD DATA



TOXICITY:      No specific toxicity data available for this product. The following information is for Hydromorphone

               Hydrochloride.



               LD50 :          Subcutaneous (rat)         51 mg/kg

                               Subcutaneous (mouse) 120 mg/kg

                               Intravenous (mouse)        55 mg/kg

               LDLo:           Intravenous (cat)          3 mg/kg

                               Intravenous (rabbit)       2500 micrograms/kg



Reproductive Effects Data [RTECS]



       The usual adult oral dose of hydromorphone hydrochloride is 2 mg every three to six hours as needed. Adverse

       effects include dizziness, sedation, nausea, vomiting, constipation, abdominal pain, skin rashes, lightheadedness,

       headache, weakness, euphoria, dysphoria, hallucinations, visual disturbances, liver dysfunction and palpitations.

MSDS - Hydromorphone HCl 3mg Suppositories                                                               Page 3 of 5

     Central nervous system depression, respiratory depression, pinpoint pupils, coma, body temperature and blood

     pressure may fall. Possible allergic reaction to dust if inhaled, ingested or in contact with skin.

CARCINOGEN LISTED BY:                 NTP         Yes ( ) No ( X )

                                      IARC        Yes ( ) No ( X )

                                      OSHA Yes ( ) No ( X )

                                      Other       Yes ( ) No ( X )



SIGNS AND SYMPTOMS OF OVEREXPOSURE:



        INHALATION: No adverse effects expected under normal conditions of use.



        EYE CONTACT: Will cause slight to moderate irritation, may cause narcotic effect exhibited by pupil

        contraction.



        SKIN CONTACT: May cause slight irritation, absorption may occur through skin breakage or inflammation.



        INGESTION: Narcotic. In addition to analgesic action, may cause gastric disturbance evidenced by nausea,

        vomiting, and constipation. Ingestion of large amounts may cause central nervous system depression,

        respiratory or cardiac collapse, coma and death.



CHRONIC EFFECTS OF OVEREXPOSURE: May cause addiction. Possible hypersensitization to this material.



MEDICAL CONDITIONS AGGRAVATED BY OVEREXPOSURE: Sensitization may occur evidenced by skin

rashes, cough, stuffy nose, asthma and other allergic complaints.



OTHER PRECAUTIONS TO CONSIDER: Persons developing hypersensitivity (anaphylactic) reactions must receive

immediate medical attention. Material may be irritating to mucous membranes and respiratory tract. Risk-benefit must

be considered because opioid analgesics cross the placenta. Regular use during pregnancy may cause physical

dependency in the fetus, leading to withdrawal symptoms (convulsions, irritability, excessive crying, tremors, hyperactive

reflexes, fever, vomiting, diarrhea, sneezing and yawning) in the neonate. Although teratogenic effects in humans have

not been documented, controlled studies have not been done. Studies in animals have shown hydromorphone to be

teratogenic in very high doses (FDA pregnancy Category C) [USP DI 9th ed. 1989]. Wash thoroughly after handling

suppositories.



EMERGENCY FIRST AID PROCEDURES:



        INHALATION: No adverse effects expected due to inhalation under normal conditions of use.



        EYE CONTACT: Flush with copious amounts of water. Seek medical attention.



        SKIN CONTACT: Wash thoroughly with soap and water. Seek medical attention.



        INGESTION: Seek immediate medical attention.

MSDS - Hydromorphone HCl 3mg Suppositories                                                          Page 4 of 5





                        SECTION 6 - CONTROL AND PROTECTIVE MEASURES



RESPIRATORY PROTECTION: No special respiratory protection required under normal conditions of use.





PROTECTIVE GLOVES: Latex gloves recommended.



EYE PROTECTION: No special protection required under normal conditions of use, however, prudence indicates that

safety glasses or goggles be worn to avoid incidental eye contact.



VENTILATION: No special ventilation required under normal conditions of use.



OTHER PROTECTIVE EQUIPMENT: No special protective equipment required under normal conditions of use.



HYGIENIC WORK PRACTICES: Wash thoroughly after handling and wash contaminated clothing before reuse.



                       SECTION 7 - HANDLING AND STORAGE PRECAUTIONS



HANDLING PRECAUTIONS: Avoid contact with eyes, skin or clothing. Wash thoroughly after handling and wash

any contaminated clothing before reuse.



STORAGE PRECAUTIONS: CONTROLLED SUBSTANCE (Schedule II). Storage location must comply with all

Drug Enforcement Administration regulations.



                           SECTION 8 - SPILL AND DISPOSAL PROCEDURES



STEPS TO BE TAKEN IN CASE OF SPILL OR DISCHARGE: Wearing suitable eye and hand protection sweep

or scrape up spillage and place in a tight container. Wash spill site. Wash thoroughly or shower after handling and

wash all clothing before reuse.



WASTE DISPOSAL METHOD: Dispose of in accordance with all applicable local, state, federal, and environmental

regulations.

MSDS - Hydromorphone HCl 3mg Suppositories                                                                Page 5 of 5





                                            SECTION 9 - DISCLAIMER



The information contained in this Material Safety Data Sheet has been compiled from reliable sources and is believed to

be correct as of the date issued. It is the responsibility of the user to determine the appropriateness and applicability to

their situation. Paddock Laboratories, Inc. disclaims any expressed or implied warranty as to the accuracy of the above

information and shall not be held liable for any direct, incidental, or consequential damages from use or reliance on the

above information.



_________________________________________________________________________________________

DEFINITIONS OF ABBREVIATIONS USED:



 ACGIH:         American Conference of Governmental Industrial Hygienists

 CAS:           Chemical Abstract Service

 IARC:          Internal Agency for Research on Cancer

 IDLH:          Immediately Dangerous to Life or Health level

 LC50 :         Median Lethal Concentration

 LD50 :         Median Lethal Dose

 MSHA:          Mine Safety and Health Administration

 N/A:           Not available

 NIOSH:         National Institute for Occupational Safety and Health

 NTP:           National Toxicology Program

 OSHA:          Occupational Safety and Health Administration

 PEL:           Permissible Exposure Limit

 STEL:          Short Term Exposure Limit

 TLV:           Threshold Limit Value

 TWA:           Time Weighted Average