2525 West End Avenue, Suite 950
Nashville, TN 37203, USA
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VERSION DATE: March 13, 2006; Valid Until Revised
MATERIAL SAFETY DATA SHEET
Cumberland Pharmaceuticals believes the information provided herein is accurate but makes no representations or
warranties, either expressed or implied, and assumes no responsibility for any damage or injuries, which may result from
use or reliance upon this information.
Material Name: KRISTALOSE
Chemical Formula: C12H22O11
Molecular Weight: 342.3
Synonyms: Lactulose, Lactulose Crystals, 4-O-β-D-Galactopyranosyl-D-fructofuranose.
Characteristics: KRISTALOSE is an odorless, white crystalline powder which is freely soluble in water.
General Use: KRISTALOSE in its finished dosage form is an oral solution intended for the treatment of
constipation. While in its reconstituted finished dosage form KRISTALOSE is not regarded as OSHA hazardous.
Emergency Telephone Number: 1-615-423-8460
CAS Number: 4618-18-2
SECTION I - PRODUCT IDENTIFICATION
SECTION II - COMPOSITION
SECTION III – HEALTH HAZARD DATA
Presents little hazard to human health and the environment.
Carcinogenicity: ACGIH, IARC, NTP, and OSHA do not list KRISTALOSE as a carcinogen.
Teratogenic Effects: A study performed in rats, mice and rabbits using oral doses of up to three (3) or six (6) times
the normal human oral dose revealed no evidence of harm to the fetus due to KRISTALOSE.There are no
adequate data regarding the potential reproductive toxicity of KRISTALOSE in a non-rodent species or adequate
studies in pregnant women. During pregnancy, KRISTALOSE should be used only if the potential benefit justifies
the potential risks to the fetus.
Target Organs: Skin, eyes, and respiratory tract.
Primary Entry Routes: Inhalation, ingestion, and skin contact.
Acute Effects: Eyes: KRISTALOSE may cause mild eye irritation.
Skin: KRISTALOSE may cause