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Benadryl Allergy Ultratab Kapseal Capsules
Product name
Therapeutic use Allergy medication
Description Solid
SECTION 2 - COMPOSITION/INFORMATION ON INGREDIENTS
Ingredient CAS Number Amount
147-24-0 13 .9%
Diphenhydramine hydrochloride*
1 .1%
Magnesium stearate* 557-04-0
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
NOTE : This document has been prepared in accordance with standards for
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 .
Skin Wash exposed area with soap and water, remove contaminated clothing
and obtain medical assistance if irritation occurs .
Inhalation Remove to fresh air. If discomfort persists, get medical attention .
Ingestion In the event of swallowing this material, dilute with large quantities of
water or milk. Medical treatment should be supportive and symptomatic .
Note to physician Drowsiness may occur if swallowed .
SECTION 5 - FIRE FIGHTING MEASURES
Fire fighting instructions Wear approved positive pressure, self-contained breathing apparatus and
full protective turn out gear.
Extinguishing media Use carbon dioxide, dry chemical, or water spray .
Flash point Not applicable
SECTION 6 - ACCIDENTAL RELEASE MEASURES
General Review Sections 3, 8 and 12 before proceeding with clean up .
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
General handling IF TABLETS OR CAPSULES ARE CRUSHED AND/OR BROKEN,
AVOID BREATHING DUST AND AVOID CONTACT WITH EYES,
SKIN AND CLOTHING .
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SECTION 7 - HANDLING AND STORAGE . . . continued
Storage conditions Keep in tightly closed containers away from heat and light .
Temperature range No data available
for storage
SECTION 8 - EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure limits
Compound Issuer Type OEL
Diphenhydramine Pfizer TWA-8 Hr 0 .05 mg/m3 (as Diphenhydramine)
hydrochloride
Magnesium stearate ACGIH TWA-8 Hr 10 mg/m 3 (stearates)
Exposure information The exposure limit(s) listed for solid components are only relevant if dust
may be generated.
Ventilation Good general ventilation should be sufficient to control airborne levels .
Eye protection Glasses or goggles are recommended if eye contact is possible .
Skin protection Wear protective clothing when working with large quantities .
Hand protection Wear gloves when working with large quantities .
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
Physical form Solid
Color Colorless
Molecular weight Mixture
Molecular formula Mixture
pH No data available
Soluble
Water solubility
No data available
Solvent solubility
SECTION 10 - STABILITY AND REACTIVITY
Reactivity Stable
Conditions to avoid Avoid direct sunlight, conditions that might generate heat, and sources of
ignition.
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SECTION 10 - STABILITY AND REACTIVITY . .. continued
None known
Incompatibilities
Hazardous None known
decomposition
products
No data available
Hazardous
polymerization
SECTION 11 - TOXICOLOGY INFORMATION
Acute toxicity
Tpe Route Species Dosage
Comvound
Rat 500 mg/kg
Diphenhydramine LD50 Oral
hydrochloride
LD50 Oral Mouse 114 mg/kg
Mild
Irritation Ocular Rabbit
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
20 mg/kg
LD50 IV Mouse
Magnesium stearate LC50/1H Inhalation Rat >2000 mg/m3
LD50 Oral Rat >2000 mg/kg
LD50 Oral Rat >1000 mg/kg
LC50 Inhalation Rat >2000 mg/m3
Possible eye irritant
Eye
Negligible skin irritation is possible
Skin
Not determined for this product .
Inhalation
Ingestion Not determined for this product .
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 .
Reproductive effects Not determined for this product
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
Environmental overview The environmental characteristics of this material have not been fully
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
General shipping Not regulated for transport under USDOT, EUADR, IATA, or IMDG
instructions regulations .
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
The information contained in this Material Safety Data Sheet is
Disclaimer
believed to be accurate, and while it is provided in good faith, it is
without a warranty of any kind, express or implied .
Pfizer Inc .
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