MATERIAL SAFETY DATA SHEET
SECTION 1 - CHEMICAL PRODUCT & COMPANY IDENTIFICATION
Pfizer Consumer Healthcare (973) 385-2000
Emergency telephone
Pfizer Inc 24 hours
Hours of operation
201 Tabor Road
Morris Plains, New Jersey 07950
Product name Benadryl Allergy Ultratab Kapseal Capsules
Allergy medication
Therapeutic use
Solid
Description
SECTION 2 - COMPOSITION/INFORMATION ON INGREDIENTS
Ingredient CAS Number Amount
Diphenhydramine hydrochloride* 147-24-0 13.9%
Magnesium stearate* 557-04-0 1.1%
Lactose NF, monohydrate 64044-51-5 Proprietary
*Hazardous
Note: Ingredient(s) indicated as hazardous have been assessed under standards
for workplace safety.
SECTION 3 - HAZARDS IDENTIFICATION
Signal word CAUTION!
Statements of hazard MAY CAUSE NERVOUS SYSTEM EFFECTS.
MAY CAUSE EYE IRRITATION.
Possible eye irritant
Eye effects
Negligible skin irritant.
Skin effects
Inhalation effects No data available. An Occupational Exposure Limit has been established
for one or more of the ingredients (see Section 8).
No data available.
Ingestion effects
For a more detailed discussion of potential health hazards and toxicity see
Additional data
Section 11.
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SECTION 3 - HAZARDS IDENTIFICATION ... continued
This document has been prepared in accordance with standards for
NOTE:
workplace safety, which require the inclusion of all known hazards of the
product or its ingredients regardless of the potential risk. The
precautionary statements and warnings included may not apply in all
cases. Your needs may vary depending upon the potential for exposure in
your workplace.
SECTION 4 - FIRST AID MEASURES
Eyes Immediately flush eyes with water for at least 15 minutes. If irritation
occurs or persists, get medical attention.
Wash exposed area with soap and water, remove contaminated clothing
Skin
and obtain medical assistance if irritation occurs.
Inhalation Remove to fresh air. If discomfort persists, get medical attention.
In the event of swallowing this material, dilute with large quantities of
Ingestion
water or milk. Medical treatment should be supportive and symptomatic.
Drowsiness may occur if swallowed.
Note to physician
SECTION 5 - FIRE FIGHTING MEASURES
Wear approved positive pressure, self-contained breathing apparatus and
Fire fighting instructions
full protective turn out gear.
Use carbon dioxide, dry chemical, or water spray.
Extinguishing media
Not applicable
Flash point
SECTION 6 - ACCIDENTAL RELEASE MEASURES
Review Sections 3, 8 and 12 before proceeding with clean up.
General
Small spill Vacuum or sweep material into appropriate container for disposal. Clean
spill area thoroughly.
Large spill Contain the source of the spill or leak if it is safe to do so. Vacuum or
sweep material into appropriate container for disposal. Clean spill area
thoroughly.
SECTION 7 - HANDLING AND STORAGE
IF TABLETS OR CAPSULES ARE CRUSHED AND/OR BROKEN,
General handling
AVOID BREATHING DUST AND AVOID CONTACT WITH EYES,
SKIN AND CLOTHING.
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SECTION 7 - HANDLING AND STORAGE ... continued
Keep in tightly closed containers away from heat and light.
Storage conditions
No data available
Temperature range
for storage
SECTION 8 - EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure limits
Compound Issuer Type OEL
Diphenhydramine Pfizer TWA-8 Hr 0.05 mg/m?(as Diphenhydramine)
hydrochloride
Magnesium stearate ACGIH TWA-8 Hr 10 mg/m?(stearates)
The exposure limit(s) listed for solid components are only relevant if dust
Exposure information
may be generated.
Good general ventilation should be sufficient to control airborne levels.
Ventilation
Glasses or goggles are recommended if eye contact is possible.
Eye protection
Wear protective clothing when working with large quantities.
Skin protection
Wear gloves when working with large quantities.
Hand protection
Respiratory protection Respirators are not required for normal use of this material. If the
applicable Occupational Exposure Limits (OELs) is exceeded, wear an
appropriate respirator with a protection factor sufficient to control
exposures to below the OEL.
SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES
Solid
Physical form
Colorless
Color
Mixture
Molecular weight
Mixture
Molecular formula
No data available
pH
Soluble
Water solubility
No data available
Solvent solubility
SECTION 10 - STABILITY AND REACTIVITY
Stable
Reactivity
Avoid direct sunlight, conditions that might generate heat, and sources of
Conditions to avoid
ignition.
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SECTION 10 - STABILITY AND REACTIVITY ... continued
None known
Incompatibilities
None known
Hazardous
decomposition
products
No data available
Hazardous
polymerization
SECTION 11 - TOXICOLOGY INFORMATION
Acute toxicity
Compound Type Route Species Dosage
Diphenhydramine LD50 Oral Rat 500 mg/kg
hydrochloride
LD50 Oral Mouse 114 mg/kg
Irritation Ocular Rabbit Mild
LD50 Oral Guinea Pig 284 mg/kg
LDmin. Oral Human 10.1 mg/kg
LD50 IV Dog 24 mg/kg
LD50 IV Hamster 10 mg/kg
LD50 IV Mouse 20 mg/kg
Magnesium stearate LC50/1H Inhalation Rat >2000 mg/m?br>
LD50 Oral Rat >2000 mg/kg
LD50 Oral Rat >1000 mg/kg
LC50 Inhalation Rat >2000 mg/m?br>
Possible eye irritant
Eye
Negligible skin irritation is possible
Skin
Not determined for this product.
Inhalation
Not determined for this product.
Ingestion
Not determined for this product.
Mutagenicity
Not determined for this product.
Subchronic effects
Not determined for this product.
Chronic effects/
carcinogenicity
None of the components of this formulation is listed as a carcinogen by
Carcinogen status
IARC, NTP or OSHA.
Not determined for this product
Reproductive effects
Not determined for this product.
Teratogenicity
Effects reported during consumer use include drowsiness and excitation.
Additional information
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SECTION 12 - ECOLOGICAL INFORMATION
The environmental characteristics of this material have not been fully
Environmental overview
evaluated. Releases to the environment should be avoided. See aquatic
toxicity data for individual components below:
SECTION 13 - DISPOSAL INFORMATION
Observe all local and national regulations when disposing of this material.
Disposal procedure
SECTION 14 - TRANSPORTATION INFORMATION
Not regulated for transport under USDOT, EUADR, IATA, or IMDG
General shipping
regulations.
instructions
SECTION 15 - REGULATORY INFORMATION
Not classified
EU Classification
This product has been classified in accordance with the hazard criteria of
Canadian WHMIS
the CPR and the MSDS contains all of the information required by the
CPR.
SECTION 16 - OTHER
Disclaimer The information contained in this Material Safety Data Sheet is
believed to be accurate, and while it is provided in good faith, it is
without a warranty of any kind, express or implied.
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