BEGIN MSDS 00225847
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SECTION 1 CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
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WHITEHALL-ROBINS 24 HR Emergency Medical Information:
1407 Cummings Drive 610-688-4400
Richmond, VA 23220 CHEMTREC(R) USA, CAN, PR: 800-424-9300
804-257-2000 International: 202-483-7616
SUBSTANCE: ROBITUSSIN
TRADE NAMES/SYNONYMS:
ROBITUSSIN COUGH AND COLD INFANT DROPS; ROBITUSSIN DM INFANT DROPS; ROBITUSSIN
DM; 00225847
PRODUCT USE: pharmaceutical
CREATION DATE: Sep 07 2000
REVISION DATE: Oct 05 2000
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SECTION 2 COMPOSITION, INFORMATION ON INGREDIENTS
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COMPONENT: DEXTROMETHORPHAN HYDROBROMIDE
CAS NUMBER: 125-69-9
EC NUMBER (EINECS): 204-750-1
PERCENTAGE: 0.2
COMPONENT: PSEUDOEPHEDRINE HYDROCHLORIDE
CAS NUMBER: 345-78-8
EC NUMBER (EINECS): 206-462-1
PERCENTAGE: 0-0.6
COMPONENT: GUAIFENESIN
CAS NUMBER: 93-14-1
EC NUMBER (EINECS): 202-222-5
PERCENTAGE: 2-4
COMPONENT: POLYVINYLPYRROLIDONE
CAS NUMBER: 9003-39-8
EC NUMBER: Not assigned.
PERCENTAGE: 0-6.0
COMPONENT: GLYCERIN
CAS NUMBER: 56-81-5
EC NUMBER (EINECS): 200-289-5
PERCENTAGE: >1
COMPONENT: PROPYLENE GLYCOL
CAS NUMBER: 57-55-6
EC NUMBER (EINECS): 200-338-0
PERCENTAGE: 0-5.0
COMPONENT: MALTITOL SOLUTION
CAS NUMBER: Not assigned.
EC NUMBER: Not assigned.
PERCENTAGE: 0-13.58
COMPONENT: HIGH FRUCTOSE CORN SYRUP
CAS NUMBER: Not assigned.
EC NUMBER: Not assigned.
PERCENTAGE: 31-35
COMPONENT: POLYETHYLENE GLYCOLS
CAS NUMBER: 25322-68-3
EC NUMBER: Not assigned.
PERCENTAGE: 0-10
COMPONENT: CITRIC ACID
CAS NUMBER: 77-92-9
EC NUMBER (EINECS): 201-069-1
PERCENTAGE: 0.2-1.13
COMPONENT: DEXTROSE
CAS NUMBER: 50-99-7
EC NUMBER (EINECS): 200-075-1
PERCENTAGE: 0-24.7
COMPONENT: SACCHARIN SODIUM SALT
CAS NUMBER: 128-44-9
EC NUMBER (EINECS): 204-886-1
PERCENTAGE: <1
COMPONENT: WATER
CAS NUMBER: 7732-18-5
EC NUMBER (EINECS): 231-791-2
PERCENTAGE: >1
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SECTION 3 HAZARDS IDENTIFICATION
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NFPA RATINGS (SCALE 0-4): HEALTH=2 FIRE=1 REACTIVITY=0
EC CLASSIFICATION (CALCULATED): Not determined.
EMERGENCY OVERVIEW:
COLOR: red
PHYSICAL FORM: liquid
MAJOR HEALTH HAZARDS: suspect cancer hazard in animals (saccharin sodium salt)
POTENTIAL HEALTH EFFECTS:
INHALATION:
SHORT TERM EXPOSURE: no information on significant adverse effects
LONG TERM EXPOSURE: no information on significant adverse effects
SKIN CONTACT:
SHORT TERM EXPOSURE: no information on significant adverse effects
LONG TERM EXPOSURE: no information on significant adverse effects
EYE CONTACT:
SHORT TERM EXPOSURE: dilated pupils, headache
LONG TERM EXPOSURE: no information on significant adverse effects
INGESTION:
SHORT TERM EXPOSURE: nausea, vomiting, rash, headache, dizziness,
hyperactivity or drowsiness, visual disturbances, dilated pupils, paralysis,
coma
LONG TERM EXPOSURE: same as effects reported in short term exposure, cancer
CARCINOGEN STATUS:
OSHA: N
NTP: N
IARC: Y
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SECTION 4 FIRST AID MEASURES
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INHALATION: If adverse effects occur, remove to uncontaminated area. Give
artificial respiration if not breathing. Get immediate medical attention.
SKIN CONTACT: Wash skin with soap and water for at least 15 minutes while
removing contaminated clothing and shoes. Get medical attention, if needed.
Thoroughly clean and dry contaminated clothing and shoes before reuse.
EYE CONTACT: Flush eyes with plenty of water for at least 15 minutes. Then get
immediate medical attention.
INGESTION: If a large amount is swallowed, get medical attention.
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SECTION 5 FIRE FIGHTING MEASURES
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FIRE AND EXPLOSION HAZARDS: Slight fire hazard.
EXTINGUISHING MEDIA: carbon dioxide, regular dry chemical, regular foam, water
FIRE FIGHTING: Move container from fire area if it can be done without risk.
Avoid inhalation of material or combustion by-products. Stay upwind and keep
out of low areas.
FLASH POINT: No data available.
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SECTION 6 ACCIDENTAL RELEASE MEASURES
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OCCUPATIONAL RELEASE:
Stop leak if possible without personal risk. Small spills: Absorb with sand or
other non-combustible material. Collect spilled material in appropriate
container for disposal.
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SECTION 7 HANDLING AND STORAGE
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Store and handle in accordance with all current regulations and standards.
Subject to storage regulations: U.S. FDA 21 CFR 1301. Store with acids. See
original container for storage recommendations.
Handle as a corrosive liquid. When mixing, slowly add to water to minimize
heat generation and spattering. Keep emergency spill kit near storage and use
areas.
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SECTION 8 EXPOSURE CONTROLS, PERSONAL PROTECTION
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EXPOSURE LIMITS:
DEXTROMETHORPHAN HYDROBROMIDE:
630 ug/m3 recommended TWA 8 hour(s) (AHP OEG)
PSEUDOEPHEDRINE HYDROCHLORIDE:
200 ug/m3 recommended TWA 8 hour(s) (AHP OEG)
GUAIFENESIN:
2230 ug/m3 recommended TWA 8 hour(s) (AHP OEG)
GLYCERIN:
GLYCERIN (MIST):
5 mg/m3 OSHA TWA (respirable dust fraction)
15 mg/m3 OSHA TWA (total dust)
10 mg/m3 OSHA TWA (total particulate) (vacated by 58 FR 35338, June 30,
1993)
10 mg/m3 ACGIH TWA
10 mg/m3 UK OES TWA
MEASUREMENT METHOD: Particulate filter; Gravimetric; NIOSH IV # 0500,
Nuisance Dust (total), # 0600 (respirable)
PROPYLENE GLYCOL:
50 ppm (156 mg/m3) AIHA recommended TWA (total particulate)
10 mg/m3 AIHA recommended TWA (particulate)
150 ppm (474 mg/m3) UK OES TWA (total (vapour and particulates))
10 mg/m3 UK OES TWA (particulates)
POLYETHYLENE GLYCOLS:
1000 mg/m3 DFG MAK (peak limitation category-IV) (inhalable dust fraction)
10 mg/m3 AIHA recommended TWA (aerosol)
VENTILATION: Provide local exhaust ventilation system. Ensure compliance with
applicable exposure limits.
EYE PROTECTION: Wear splash resistant safety goggles. Provide an emergency eye
wash fountain and quick drench shower in the immediate work area.
CLOTHING: Wear appropriate chemical resistant clothing.
GLOVES: Wear appropriate chemical resistant gloves.
RESPIRATOR: Under conditions of frequent use or heavy exposure, respiratory
protection may be needed. Respiratory protection is ranked in order from
minimum to maximum. Consider warning properties before use.
Any chemical cartridge respirator with organic vapor cartridge(s).
Any chemical cartridge respirator with a full facepiece and organic vapor
cartridge(s).
Any air-purifying respirator with a full facepiece and an organic vapor
canister.
For Unknown Concentrations or Immediately Dangerous to Life or Health -
Any supplied-air respirator with full facepiece and operated in a
pressure-demand or other positive-pressure mode in combination with a
separate escape supply.
Any self-contained breathing apparatus with a full facepiece.
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SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES
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PHYSICAL STATE: liquid
COLOR: red
ODOR: Not available
BOILING POINT: Not available
FREEZING POINT: Not available
VAPOR PRESSURE: Not available
VAPOR DENSITY: Not available
SPECIFIC GRAVITY (water=1): 1.1-1.3
WATER SOLUBILITY: soluble
PH: 2.0-5.8
VOLATILITY: Not available
ODOR THRESHOLD: Not available
EVAPORATION RATE: Not available
COEFFICIENT OF WATER/OIL DISTRIBUTION: Not available
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SECTION 10 STABILITY AND REACTIVITY
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REACTIVITY: Stable at normal temperatures and pressure.
CONDITIONS TO AVOID: Avoid heat, flames, sparks and other sources of ignition.
Avoid contact with incompatible materials.
INCOMPATIBILITIES:
May be incompatible with acids, bases, and oxidizers.
HAZARDOUS DECOMPOSITION:
Thermal decomposition products: oxides of carbon
POLYMERIZATION: Will not polymerize.
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SECTION 11 TOXICOLOGICAL INFORMATION
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ROBITUSSIN:
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: diabetes, heart or cardiovascular
disorders, high blood pressure, respiratory disorders
ADDITIONAL DATA: Interactions with drugs may occur.
DEXTROMETHORPHAN HYDROBROMIDE:
TOXICITY DATA:
30 mg/kg oral-child TDLo; 57 gm/kg/5 year(s) intermittent oral-man TDLo; 350
mg/kg oral-rat LD50; 423 mg/kg subcutaneous-rat LD50; 165 mg/kg oral-mouse
LD50; 125 mg/kg subcutaneous-mouse LD50; 34 mg/kg intravenous-mouse LD50;
157 mg/kg subcutaneous-dog LD50; 30 mg/kg intravenous-dog LDLo; 19800 ug/kg
intravenous-cat LD50; 15 mg/kg intravenous-rabbit LD50; 336 mg/kg
oral-guinea pig LD50; 150 mg/kg subcutaneous-guinea pig LD50; 150 mg/kg
unreported-mammal LD50
ACUTE TOXICITY LEVEL:
Toxic: ingestion
ADDITIONAL DATA: Interactions with drugs may occur.
PSEUDOEPHEDRINE HYDROCHLORIDE:
TOXICITY DATA:
714 ug/kg oral-human TDLo; 80 mg/kg subcutaneous-rat LDLo; 371 mg/kg
oral-mouse LD50; 202 mg/kg intraperitoneal-mouse LD50; 400 mg/kg
parenteral-mouse LDLo; 75 mg/kg intravenous-rabbit LDLo; 800 mg/kg
parenteral-frog LDLo
ACUTE TOXICITY LEVEL:
Toxic: ingestion
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: high blood pressure, heart
problems, hormonal disorders, skin disorders and allergies
ADDITIONAL DATA: May be excreted in breast milk. Interactions with drugs may
occur.
Sensitization reactions may occur in persons who are allergic to other
sympathomimetics.
GUAIFENESIN:
TOXICITY DATA:
1510 mg/kg oral-rat LD50; 1 gm/kg intraperitoneal-rat LD50; 2550 mg/kg
subcutaneous-rat LD50; 360 mg/kg intravenous-rat LD50; 4 gm/kg
intramuscular-rat LD50; 690 mg/kg oral-mouse LD50; 495 mg/kg
intraperitoneal-mouse LD50; 800 mg/kg subcutaneous-mouse LD50; 400 mg/kg
intravenous-mouse LD50; 2210 mg/kg intramuscular-mouse LD50; 335 mg/kg
intravenous-dog LD50; 2553 mg/kg oral-rabbit LD50
ACUTE TOXICITY LEVEL:
Moderately Toxic: ingestion
SACCHARIN SODIUM SALT:
TOXICITY DATA:
14200 mg/kg oral-rat LD50; 7100 mg/kg intraperitoneal-rat LD50; 17500 mg/kg
oral-mouse LD50; 6 gm/kg intraperitoneal-mouse LD50; 7 gm/kg
subcutaneous-mouse LDLo; 4 gm/kg oral-rabbit LDLo; 756 gm/kg/36 week(s)
continuous oral-rat TDLo; 32400 mg/kg/54 day(s) continuous oral-rat TDLo
CARCINOGEN STATUS: IARC: Human Inadequate Evidence, Animal Sufficient
Evidence, Group 2B; EC: Category 2
Saccharin (unspecified or commercial) has been tested for carcinogenicity by
oral administration producing thyroid tumors in mice. Sodium saccharin
produced an increased incidence of bladder tumors in male rats in one
single-generation and four two-generation studies by oral administration.
Saccharin has been shown to promote the action of known carcinogens in
animals.
ACUTE TOXICITY LEVEL:
Slightly Toxic: ingestion
TUMORIGENIC DATA:
1092 gm/kg oral-rat TDLo/1 year(s) continuous; 176 mg/kg implant-mouse TDLo;
112 gm/kg oral-rat TD/8 week(s) continuous; 224 gm/kg oral-rat TD/8 week(s)
continuous; 1330 gm/kg oral-rat TD/95 week(s) continuous; 2660 gm/kg
oral-rat TD/95 week(s) continuous; 1428 gm/kg oral-rat TD/2 year(s)
continuous; 1190 gm/kg oral-rat TD/85 week(s) continuous; 1827 gm/kg
oral-rat TD/87 week(s) continuous
MUTAGENIC DATA:
mutation in microorganisms - Salmonella typhimurium 62 mmol/L (+S9); sex
chromosone loss and non disjunction - Drosophila melanogaster parenteral 5
mmol/L; sex chromosone loss and non disjunction - Drosophila melanogaster
oral 5 pph; mutation in microorganisms - Saccharomyes cerevisae 2 gm/L
(-S9); gene conversion and miotic recombination - Saccharomyes cerevisae 2
gm/L; DNA inhibition - human fibroblast 100 mmol/L; cytogenetic analysis -
human leukocyte 500 mg/L; sister chromatid exchange - human leukocyte 20
umol/L; mutation in mammalian somatic cells - human embryo 10 gm/L;
unscheduled DNA synthesis - rat oral 441 gm/kg 21 week(s)-continuous;
unscheduled DNA synthesis - rat liver 1 mg/L; mutation in microorganisms -
mouse lymphocyte 11 gm/L (+S9) 4 hour(s); DNA damage - mouse intraperitoneal
50 mg/kg; cytogenetic analysis - mouse intraperitoneal 1 gm/kg 60
hour(s)-intermittent; dominant lethal test - mouse intraperitoneal 500 mg/kg
60 hour(s)-intermittent; dominant lethal test - mouse oral 6 gm/kg 30
day(s); sperm - mouse intraperitoneal 1 gm/kg 60 hour(s); cytogenetic
analysis - hamster fibroblast 8 gm/L 48 hour(s); cytogenetic analysis -
hamster lung 1 gm/L
REPRODUCTIVE EFFECTS DATA:
15 gm/kg oral-rat TDLo 15-21 day(s) post pregnancy continuous; 325 gm/kg
oral-rat TDLo 4 week(s) male week(s) pre pregnancy/4 week(s) post
pregnancy/4 day(s) continuous; 103 gm/kg oral-mouse TDLo 30 day(s) male; 2
gm/kg oral-mouse TDLo multigenerations; 2 gm/kg intraperitoneal-mouse TDLo 1
day(s) male
ADDITIONAL DATA: May be excreted in breast milk.
HEALTH EFFECTS:
INHALATION:
ACUTE EXPOSURE:
DEXTROMETHORPHAN HYDROBROMIDE: No data available.
PSEUDOEPHEDRINE HYDROCHLORIDE: Inhalation of dust may cause irritation of
the nose and throat. If sufficient amounts are absorbed, local
vasoconstriction and systemic effects may result. Sensitization reactions
may occur in previously exposed individuals.
GUAIFENESIN: No data available.
CHRONIC EXPOSURE:
DEXTROMETHORPHAN HYDROBROMIDE: No data available.
PSEUDOEPHEDRINE HYDROCHLORIDE: Repeated or prolonged exposure may result
in sensitization. Repeated or prolonged use of sympathomimetic amines may
cause chronic nasal congestion and rhinitis medicamentosa.
GUAIFENESIN: No data available.
SKIN CONTACT:
ACUTE EXPOSURE:
DEXTROMETHORPHAN HYDROBROMIDE: May cause slight irritation.
PSEUDOEPHEDRINE HYDROCHLORIDE: Contact may cause irritation. If sufficient
amounts are absorbed, local vasoconstriction and systemic effects may
result. Sensitization dermatitis may occur in previously exposed
individuals.
GUAIFENESIN: No data available.
CHRONIC EXPOSURE:
DEXTROMETHORPHAN HYDROBROMIDE: No data available.
PSEUDOEPHEDRINE HYDROCHLORIDE: Repeated or prolonged contact may result in
sensitization.
GUAIFENESIN: No data available.
EYE CONTACT:
ACUTE EXPOSURE:
DEXTROMETHORPHAN HYDROBROMIDE: May cause slight irritation.
PSEUDOEPHEDRINE HYDROCHLORIDE: Dust may cause irritation. Application of
eye drops has caused mydriasis. Sympathomimetic amines may also cause
browache, headache, ocular pain, floating opacities, and local
vasoconstriction.
GUAIFENESIN: No data available.
CHRONIC EXPOSURE:
DEXTROMETHORPHAN HYDROBROMIDE: No data available.
PSEUDOEPHEDRINE HYDROCHLORIDE: Repeated or prolonged contact with
sympathomimetic amines may cause pigmentation of the cornea, conjunctiva
and lids.
GUAIFENESIN: No data available.
INGESTION:
ACUTE EXPOSURE:
DEXTROMETHORPHAN HYDROBROMIDE: Extremely high doses may cause nausea,
vomiting, dizziness, excitation, drowsiness, mental confusion, dilated
pupils, blurred vision, nystagmus, flushed skin, depressed respiration,
urinary retention, ataxia, stupor, and coma. One case of toxic psychosis
with hyperactivity and visual and auditory hallucinations has been
reported from overdose of a pharmaceutical product containing
dextromethorphan hydrobromide.
PSEUDOEPHEDRINE HYDROCHLORIDE: Ingestion may cause vasoconstriction,
bronchodilation and central nervous system stimulation. Symptoms may
include nervousness, dizziness, insomnia, headache, mydriasis, and
increased blood pressure and urine output. Drowsiness, increased pulse
rate, hematoma and right hemiparesis with sensory deficit were reported in
one case. Sensitization reactions including pseudo-scarlatina and
nonpigmenting fixed drug eruptions have been reported.
GUAIFENESIN: May cause gastrointestinal distress with nausea and vomiting,
drowsiness, dizziness, headache, and rash, including urticaria. No toxic
effects were noted in animals administered doses up to 5 gm/kg.
CHRONIC EXPOSURE:
DEXTROMETHORPHAN HYDROBROMIDE: Prolonged administration may cause effects
as in acute ingestion.
PSEUDOEPHEDRINE HYDROCHLORIDE: Repeated ingestion may cause sensitization.
Sympathomimetic amines may cause insomnia, tension and anxiety leading to
psychosis.
GUAIFENESIN: No data available.
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SECTION 12 ECOLOGICAL INFORMATION
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Not available
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SECTION 13 DISPOSAL CONSIDERATIONS
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Dispose in accordance with all applicable regulations.
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SECTION 14 TRANSPORT INFORMATION
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No classification assigned.
LAND TRANSPORT ADR/RID: No classification assigned.
AIR TRANSPORT IATA/ICAO: No classification assigned.
MARITIME TRANSPORT IMDG: No classification assigned.
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SECTION 15 REGULATORY INFORMATION
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U.S. REGULATIONS:
TSCA INVENTORY STATUS: E
TSCA 12(b) EXPORT NOTIFICATION: Not listed.
CERCLA SECTION 103 (40CFR302.4): N
SARA SECTION 302 (40CFR355.30): N
SARA SECTION 304 (40CFR355.40): N
SARA SECTION 313 (40CFR372.65): N
SARA HAZARD CATEGORIES, SARA SECTIONS 311/312 (40CFR370.21):
ACUTE: N
CHRONIC: Y
FIRE: N
REACTIVE: N
SUDDEN RELEASE: N
OSHA PROCESS SAFETY (29CFR1910.119): N
STATE REGULATIONS:
California Proposition 65: N
EUROPEAN REGULATIONS:
EC NUMBER: Not assigned.
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SECTION 16 OTHER INFORMATION
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COPYRIGHT 1984-2000 MDL INFORMATION SYSTEMS, INC. ALL RIGHTS RESERVED.
The information provided in this MSDS is based upon sources believed to be
accurate. However, the company assumes no responsibility for the accuracy,
completeness or suitability of this information. The product user is
responsible to determine the suitability of this information for their
particular purposes.
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