SAFETY DATA SHEET

1. Identification
Product identifier ACTIFED COMPOUND LINCTUS
Other means of identification
Synonyms ACTIFED COMPOUND LINCTUS 10/30/1.25 MG/5 ML * ACTIFIED CO LINCTUS * TUSSIFED
SYRUP * CODEINE PHOSPHATE 10 MG, PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG AND
TRIPROLIDINE HYDROCHLORIDE 1.25 MG SYRUP * CODEINE PHOSPHATE,
PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE,
FORMULATED PRODUCT
Recommended use Medicinal Product.

Recommended restrictions
Manufacturer/Importer/Supplier/Distributor information
Manufacturer
This safety data sheet is written to provide health, safety and environmental information for people
handling this formulated product in the workplace. It is not intended to provide information relevant
to medicinal use of the product. In this instance patients should consult prescribing
information/package insert/product label or consult their pharmacist or physician. For health and
safety information for individual ingredients used during manufacturing, refer to the appropriate
safety data sheet for each ingredient.
No other uses are advised.
GlaxoSmithKline Canada
Canadian Head Office
7333 Mississauga Road
Mississauga, Ontario L5N 6L4
Canada
General Information Phone Number (normal business hours): 905-819-3000
Consumer Healthcare Product Inquiries (toll free): 1-800-250-8866
Pharmaceutical, Stiefel, and Vaccine Inquiries (toll free): 1-800-387-7374

-----------------------------------------------------------------------------------------
TRANSPORTATION EMERGENCY NUMBERS
(available 24hrs/7days: multi-language response)
International Toll Call +(1) 703 527 3887
Email Address: msds@gsk.com
Website: www.gsk.com

Supplier Not available.

2. Hazard(s) identification
Classified hazards
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
Label elements
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.

3. Composition/information on ingredients
Mixtures
Chemical name Common name and synonyms CAS number %
SUCROSE SUGAR 57-50-1 45
CANE SUGAR
BEET SUGAR
CONFECTIONER'S SUGAR
ALPHA-D-GLUCOPYRANOSIDE, BETA-D-
FRUCTOFURANOSYL
GRANULATED SUGAR
SUCRALOX

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Chemical name Common name and synonyms CAS number %
GLYCERIN GLYCEROL 56-81-5 20
GLYCERIN ANHYDROUS
GLYCERINE
GLYCERITOL
GLYCYL ALCOHOL
1,2,3-PROPANETRIOL
PROPANETRIOL
GLYROL
GLYSANIN
TRIHYDROXYPROPANE
1,2,3-TRIHYDROXYPROPANE
OSMOGLYN
ETHANOL ALCOHOL ANHYDROUS 64-17-5 3.5 - < 5
ANHYDROUS ETHANOL
ANHYDROUS ETHYL ALCOHOL
ETHANOL 200 PROOF
ETHYL ALCOHOL
ETHYL ALCOHOL USP 200 PROOF (USI)
ETHYL ALCOHOL, 100%
ETHYL HYDROXIDE
GRAIN ALCOHOL
ETHANOL
PSEUDOEPHEDRINE (S-(R*,R*))-ALPHA-(1-METHYLAMINO) 345-78-8 0.6
HYDROCHLORIDE ETHYL)BENZENEMETHANOL
HYDROCHLORIDE
(+)-PSEUDOEPHEDRINE HYDROCHLORID
E
D-PSEUDOEPHEDRINE HYDROCHLORID
E GR 95006B
1803 (GW ACN)
RTECS UL5950000
(+)-PSI-EPHEDRINE HYDROCHLORIDE
71U51
CODEINE PHOSPHATE MORPHINAN-6-OL, 7,8-DIDEHYDRO-4,5- 52-28-8 0.2
EPOXY-3-METHOXY-17-METHYL-, (5
ALPHA, 6 ALPHA)-, PHOSPHATE (1:1)
(SALT)
(5 ALPHA, 6 ALPHA)-7,8-DIDEHYDRO-4,5-
EPOXY-3-METHOXY-17-METHYL-
MORPHINAN-6-OL PHOSPHATE (1:1)
(SALT)
MORPHINAN-6ALPHA-OL, 7,8-
DIDEHYDRO-4,5ALPHA-EPOXY-3-
METHOXY-17- METHYL-, PHOSPHATE (1:
1) (SALT)
7,8-DIDEHYDRO-4,5ALPHA-EPOXY-3-
METHOXY-17-METHYL-MORPHINAN-
6ALPHA-OL PHOSPHATE (1:1) (SALT)
(-)-CODIENE PHOSPHATE
CODEINE PHOSPHATE (1:1)
AH 5317G
OHS05407
RTECS QD1310000
TRIPROLIDINE HYDROCHLORIDE (E)-2-(3-(PYRROLIDIN-1YL)-1-P- 6138-79-0 0.03
MONOHYDRATE TOLYLPROP-1-ENYL) PYRIDINE
HYDROCHLORIDE MONOHYDRATE
TRANS-1-(2-PYRIDYL)-3-PYRROLIDINO-1-
P-TOLYLPROP-1-ENE
TRANS-1-(4-METHYLPHENYL)-1-(2-
PYRIDYL)-3-PYRROLIDINOPROP-1-ENE
TRIPROLIDINE HYDROCHLORIDE
AH 6494B
295C51 HCL
Other components below reportable levels 20 - < 30
All concentrations are in percent by weight (kg) unless ingredient is a gas. Gas concentrations are in percent by volume (l).

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4. First-aid measures
Inhalation
Skin contact
Eye contact
Ingestion
Most important
symptoms/effects, acute and
delayed
Indication of immediate
medical attention and special
treatment needed
General information
5. Fire-fighting measures
Suitable extinguishing media
Unsuitable extinguishing
media
Specific hazards arising from
the chemical
Special protective equipment
and precautions for firefighters
Fire fighting
equipment/instructions
Specific methods
General fire hazards
6. Accidental release measures
Personal precautions,
protective equipment and
emergency procedures
Methods and materials for
containment and cleaning up
Environmental precautions
7. Handling and storage
Precautions for safe handling
Conditions for safe storage,
including any incompatibilities
Material name: ACTIFED COMPOUND LINCTUS
129584 Version #: 04 Revision date: 06-01-2016
Move to fresh air. If breathing is difficult, trained personnel should give oxygen. Call a physician if
symptoms develop or persist. Under normal conditions of intended use, this material is not
expected to be an inhalation hazard.
Immediately flush skin with plenty of water. Take off contaminated clothing and wash before reuse.
Get medical attention if symptoms occur.
Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
If swallowed, rinse mouth with water (only if the person is conscious). If ingestion of a large
amount does occur, call a poison control center immediately. Do not induce vomiting without
advice from poison control center.
The following adverse effects have been noted with therapeutic use of this material: symptoms of
hypersensitivity (such as skin rash, hives, itching, and difficulty breathing); dry mouth; constipation;
sedation; respiratory depression; incoordination. Headache. Dizziness. Nausea, vomiting.
Unconsciousness.
No specific antidotes are recommended. Treat according to locally accepted protocols. For
additional guidance, refer to the current prescribing information or to the local poison control
information center.
In the case of accident or if you feel unwell, seek medical advice immediately (show the label
where possible). Ensure that medical personnel are aware of the material(s) involved, and take
precautions to protect themselves.
Foam. Dry chemical powder. Carbon dioxide (CO2).
Water.
During fire, gases hazardous to health may be formed.
Self-contained breathing apparatus and full protective clothing must be worn in case of fire.
Move containers from fire area if you can do so without risk.
Use standard firefighting procedures and consider the hazards of other involved materials.
Flammable liquid and vapor.
Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Wear
appropriate protective equipment and clothing during clean-up. Avoid breathing mist or vapor. Do
not touch damaged containers or spilled material unless wearing appropriate protective clothing.
Ensure adequate ventilation. Local authorities should be advised if significant spillages cannot be
contained. For personal protection, see section 8 of the SDS.
Use water spray to reduce vapors or divert vapor cloud drift.
Large Spills: Stop the flow of material, if this is without risk. Dike the spilled material, where this is
possible. Cover with plastic sheet to prevent spreading. Absorb in vermiculite, dry sand or earth
and place into containers. Following product recovery, flush area with water.
Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to
remove residual contamination.
Never return spills to original containers for re-use. For waste disposal, see section 13 of the SDS.
Avoid discharge into drains, water courses or onto the ground.
Keep away from heat/sparks/open flames/hot surfaces. - No smoking. Avoid prolonged exposure.
Do not taste or swallow. When using, do not eat, drink or smoke. Wear appropriate personal
protective equipment. Wash hands thoroughly after handling. Use care in handling/storage. Avoid
release to the environment. Do not empty into drains.
Keep away from heat, sparks and open flame. Store in original tightly closed container. Keep
container tightly closed. Store away from incompatible materials (see Section 10 of the SDS).
SDS CANADA
Issue date: 06-01-2016 3 / 14
8. Exposure controls/personal protection
Occupational exposure limits
GSK
Components Type Value Note

CODEINE PHOSPHATE 8 HR TWA 200 mcg/m3

(CAS 52-28-8)
OHC 2 RESPIRATORY
SENSITISER
2 REPRODUCTIVE
HAZARD
2 SKIN SENSITISER
2 SKIN
PSEUDOEPHEDRINE 8 HR TWA 200 mcg/m3
HYDROCHLORIDE (CAS
345-78-8)
OHC 2
TRIPROLIDINE 8 HR TWA 25 mcg/m3
HYDROCHLORIDE
MONOHYDRATE (CAS
6138-79-0)
OHC 3 SKIN SENSITISER
3 SKIN
US. ACGIH Threshold Limit Values
Components Type Value
ETHANOL (CAS 64-17-5) STEL 1000 ppm
SUCROSE (CAS 57-50-1) TWA 10 mg/m3
Canada. Alberta OELs (Occupational Health & Safety Code, Schedule 1, Table 2)
Components Type Value Form

ETHANOL (CAS 64-17-5) TWA 1880 mg/m3

1000 ppm
GLYCERIN (CAS 56-81-5) TWA 10 mg/m3 Mist.
SUCROSE (CAS 57-50-1) TWA 10 mg/m3
Canada. British Columbia OELs. (Occupational Exposure Limits for Chemical Substances, Occupational Health and
Safety Regulation 296/97, as amended)
Components Type Value Form
ETHANOL (CAS 64-17-5) STEL 1000 ppm
GLYCERIN (CAS 56-81-5) TWA 3 mg/m3 Respirable mist.
10 mg/m3 Mist.
SUCROSE (CAS 57-50-1) TWA 3 mg/m3 Respirable fraction.
10 mg/m3 Total dust.
Canada. Manitoba OELs (Reg. 217/2006, The Workplace Safety And Health Act)
Components Type Value
ETHANOL (CAS 64-17-5) STEL 1000 ppm
SUCROSE (CAS 57-50-1) TWA 10 mg/m3
Canada. Ontario OELs. (Control of Exposure to Biological or Chemical Agents)
Components Type Value Form

ETHANOL (CAS 64-17-5) STEL 1000 ppm

GLYCERIN (CAS 56-81-5) TWA 10 mg/m3 Mist.
SUCROSE (CAS 57-50-1) TWA 10 mg/m3
Canada. Quebec OELs. (Ministry of Labor - Regulation Respecting the Quality of the Work Environment)
Components Type Value Form

ETHANOL (CAS 64-17-5) TWA 1880 mg/m3

1000 ppm
GLYCERIN (CAS 56-81-5) TWA 10 mg/m3 Mist.
SUCROSE (CAS 57-50-1) TWA 10 mg/m3

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 US. OSHA Table Z-1 Limits for Air Contaminants (29 CFR 1910.1000)
Components Type Value Form

ETHANOL (CAS 64-17-5) PEL 1900 mg/m3

1000 ppm
GLYCERIN (CAS 56-81-5) PEL 5 mg/m3 Respirable fraction.
15 mg/m3 Total dust.
SUCROSE (CAS 57-50-1) PEL 5 mg/m3 Respirable fraction.
15 mg/m3 Total dust.
Biological limit values No biological exposure limits noted for the ingredient(s).
Exposure guidelines
Appropriate engineering General ventilation normally adequate.
controls
Individual protection measures, such as personal protective equipment
Eye/face protection Not normally needed. If contact is likely, safety glasses with side shields are recommended.

Skin protection
Hand protection Not normally needed. For prolonged or repeated skin contact use suitable protective gloves.
Other Not normally needed. Wear suitable protective clothing as protection against splashing or
contamination.
Respiratory protection No personal respiratory protective equipment normally required. When workers are facing
concentrations above the exposure limit they must use appropriate certified respirators.
Thermal hazards Wear appropriate thermal protective clothing, when necessary.
General hygiene Always observe good personal hygiene measures, such as washing after handling the material
considerations and before eating, drinking, and/or smoking. Routinely wash work clothing and protective
equipment to remove contaminants. For advice on suitable monitoring methods, seek guidance
from a qualified environment, health and safety professional.

9. Physical and chemical properties

Appearance
Physical state Liquid.
Form Bottle.
Color Not available.
Odor Not available.
Odor threshold Not available.
pH Not available.
Melting point/freezing point Not available.
Initial boiling point and boiling Not available.
range
Flash point 109.4 °F (43 °C) Closed Cup (Estimation based on components).
Evaporation rate Not available.
Flammability (solid, gas) Not applicable.
Upper/lower flammability or explosive limits
Flammability limit - lower Not available.
(%)
Flammability limit - upper Not available.
(%)
Explosive limit - lower (%) Not available.
Explosive limit - upper (%) Not available.
Vapor pressure Not available.
Vapor density Not available.
Relative density Not available.
Solubility(ies)
Solubility (water) Not available.

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Partition coefficient Not available.
(n-octanol/water)
Auto-ignition temperature Not available.
Decomposition temperature Not available.
Viscosity Not available.
Other information
Explosive properties Not explosive.
Oxidizing properties Not oxidizing.

10. Stability and reactivity

Reactivity
Chemical stability
Possibility of hazardous
reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition
products
The product is stable and non-reactive under normal conditions of use, storage and transport.
Material is stable under normal conditions.
Hazardous polymerization does not occur.
Heat, flames and sparks. Contact with incompatible materials.
Alkaline metals.
None known. Irritating and/or toxic fumes and gases may be emitted upon the product's
decomposition.

11. Toxicological information

Information on likely routes of exposure
Inhalation Under normal conditions of intended use, this material is not expected to be an inhalation hazard.
Skin contact Health injuries are not known or expected under normal use. May cause an allergic skin reaction.
Eye contact Direct contact with eyes may cause temporary irritation.
Ingestion May be harmful if swallowed. However, ingestion is not likely to be a primary route of occupational
exposure.
Symptoms related to the The following adverse effects have been noted with therapeutic use of this material: symptoms of
physical, chemical and hypersensitivity (such as skin rash, hives, itching, and difficulty breathing); dry mouth;
toxicological characteristics constipation; sedation; respiratory depression; incoordination. Headache. Dizziness. Nausea,
vomiting. Unconsciousness.
Information on toxicological effects
Acute toxicity May be harmful if swallowed.
Components Species Test Results
CODEINE PHOSPHATE (CAS 52-28-8)
Acute
Oral
LD50 Rat 250 mg/kg
Subacute
Oral
LD Rat 450 mg/kg/day, 14 Day dietary study
LOEL Mouse 600 mg/kg/day, 14 Day organ weight
changes
Rat 125 mg/kg/day, 14 Day dietary study
NOAEL Rat 250 mg/kg/day, 14 Day dietary study
Subchronic
Oral
LOEL Mouse 460 mg/kg/day, 13 weeks dietary study
Rat 50 mg/kg/day, 13 weeks Blood parameters
- dietary study.
NOAEL Rat 450 mg/kg/day, 13 weeks

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Components Species Test Results
ETHANOL (CAS 64-17-5)
Acute
Oral
LD50 Rat > 2000 mg/kg
Chronic
Oral
LOAEL Monkey 40 %, 48 months % ingested calories
Subacute
Oral
LOEL Rat 16.9 g/kg, 4 weeks Dietary - Dose given as
g/kg/day
6 %, 4 weeks percent in diet - continuous
Subchronic
Inhalation
LOEL Rat 2 ml, 36 weeks haematological parameters
NOAEL Guinea pig 3000 ppm No adverse effects
Rat 86 mg/m3, 90 Day Daily dosing
Oral
LOAEL Rat 5000 mg/kg/day, 10 weeks Liver toxicity
80 ml/kg, 85 Day Daily dose - Liver toxicity
10.2 g/kg, 12 weeks Dosed in drinking
water - Continuous
7.7 g/kg, 12 weeks Dosed in drinking water
- continuous
GLYCERIN (CAS 56-81-5)
Acute
Oral
LD50 Rat > 2000 mg/kg
PSEUDOEPHEDRINE HYDROCHLORIDE (CAS 345-78-8)
Acute
Oral
LD50 Mouse 371 mg/kg
TRIPROLIDINE HYDROCHLORIDE MONOHYDRATE (CAS 6138-79-0)
Acute
Dermal
LD50 Rabbit > 5000 mg/kg
Inhalation
LC50 Rat > 17.1 mg/l Highest practical concentation
possible
Oral
LD50 Rat 840 mg/kg National Center for Toxicology
Research Technical Report
478 mg/kg combined Male and Female
Subchronic
Oral
LOEL Mouse 121 mg/kg/day 90 day feed study
NOAEL Rat 20 mg/kg/day 90 day feed study

* Estimates for product may be based on additional component data not shown.
Skin corrosion/irritation Prolonged skin contact may cause temporary irritation.

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 Corrosivity
TRIPROLIDINE HYDROCHLORIDE Acute dermal irritation
MONOHYDRATE Result: Non-irritant
Species: Rabbit
ETHANOL OECD 404
Result: Negative; not considered a significant irritant
Species: Rabbit
Serious eye damage/eye Direct contact with eyes may cause temporary irritation.
irritation
Eye
TRIPROLIDINE HYDROCHLORIDE Acute ocular irritation
MONOHYDRATE Result: Moderate Irritant
Species: Rabbit
ETHANOL OECD 405
Result: Severe
Species: Rabbit
Respiratory or skin sensitization
Canada - Alberta OELs: Irritant
GLYCERIN (CAS 56-81-5) Irritant
Respiratory sensitization May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Skin sensitization Allergic skin reactions might occur following repeated contact with this material in susceptible
individuals.
Sensitization
TRIPROLIDINE HYDROCHLORIDE Maximisation assay (Magnusson and Kligman)
MONOHYDRATE Result: Positive
Species: Guinea pig
ETHANOL OECD 406
Result: Negative
Species: Guinea pig
CODEINE PHOSPHATE Occupational exposure, Literature data
Result: Respiratory and dermal sensitisation.
Species: Human
Germ cell mutagenicity May cause genetic defects.
Mutagenicity
ETHANOL Ames
Result: Negative
TRIPROLIDINE HYDROCHLORIDE Ames
MONOHYDRATE Result: Negative
CODEINE PHOSPHATE Ames, NTP
Result: Negative
ETHANOL Chromosomal Aberration Assay In Vitro, CHO cells
Result: Negative
CODEINE PHOSPHATE Chromosomal Aberration Assay In Vitro, CHO cells, NTP
Result: Negative
ETHANOL Dominant lethal assay
Result: Positive
Species: Mouse
Dominant lethal assay
Result: Positive
Species: Rat
Gene mutation and repair
Result: Negative
Species: Bacteria
Gene mutation and repair
Result: Positive
Species: Bacteria
In vitro cytogenetics assay
Result: Positive
In vitro cytogenetics assay
Result: Positive
Species: Aspergillus niger
CODEINE PHOSPHATE In vivo Micronucleus, Physician's Desk Reference
Result: Negative
Species: Mouse

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 Mutagenicity
ETHANOL L5178Y mouse lymphoma thymidine kinase locus assay
Result: Weakly positive
CODEINE PHOSPHATE Sister Chromatid Exchange, NTP
Result: Positive
ETHANOL Yeast mutation
Result: Negative
Yeast mutation
Result: Positive
TRIPROLIDINE HYDROCHLORIDE in vitro micronucleus assay
MONOHYDRATE Result: Equivocal
ETHANOL in vitro micronucleus assay
Result: Negative
in vivo cytogenetics assay
Result: Negative
Species: Hamster
in vivo cytogenetics assay
Result: Negative
Species: Rat
in vivo cytogenetics assay
Result: Positive
Species: Mouse
sister chromatid exchange
Result: Positive
Carcinogenicity Carcinogenic effects are not expected as a result of occupational exposure. Contains a material
(ethanol) classified as a carcinogen by external agencies. These effects are linked only to high
doses of this substance; lower doses did not cause this adverse effect.
ETHANOL 0, inadequate study
Result: Increase in liver sarcomas
Species: Mouse
0, inadequate study
Result: Negative
Species: Hamster
Test Duration: 807 Day
0, inadequate study
Result: Negative
Species: Mouse
Test Duration: 1020 Day
0, inadequate study
Result: Negative
Species: Rat
0, inadequate study
Result: Negative
Species: Rat
Test Duration: 78 weeks
0, inadequate study
Result: Time to tumour reduced
Species: Mouse
Test Duration: 80 weeks
CODEINE PHOSPHATE 100 - 400 mg/kg/day, NTP study
Result: Negative
Species: Mouse
Test Duration: 106 weeks
15 - 80 mg/kg/day, NTP study
Result: Negative
Species: Rat
Test Duration: 106 weeks
ETHANOL Epidemiology, causation linked to excessive consumption.
Species: Human
Organ: oral cavity, larynx, pharynx, oesophagus, liver
Neonatal, inadequate study
Result: Negative
Species: Rat
ACGIH Carcinogens
SUCROSE (CAS 57-50-1) A4 Not classifiable as a human carcinogen.
Canada - Manitoba OELs: carcinogenicity
ETHANOL (CAS 64-17-5) Confirmed animal carcinogen with unknown relevance to humans.
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 SUCROSE (CAS 57-50-1) Not classifiable as a human carcinogen.
Reproductive toxicity Health injuries are not known or expected under normal use. Components in this product have
been shown to cause birth defects and reproductive disorders in laboratory animals. These effects
are linked only to high doses of this substance; low doses did not produce this adverse effect.
Reproductivity
ETHANOL 0.3 - 4.1 g/kg Embryo-foetal development - Oral, daily dose
Species: Monkey
Organ: facial anomolies, nervous system dysfunction
1 - 2 g/kg Embryo-foetal development - Oral, daily dose
Result: embryolethality
Species: Rat
1.8 g/kg Embryo-foetal development - Oral, daily dose
Result: Increased abortion
Species: Monkey
CODEINE PHOSPHATE 120 mg/kg/day Embryo-foetal development, Literature data
Result: Maternal toxicity; adverse foetal effects
Species: Rat
150 - 150 mg/kg/day Embryo-foetal development, Literature
data
Result: Foetal toxicity, increased resorptions.
Species: Mouse
150 mg/kg/day Embryo-foetal development, Literature data
Result: Maternal toxicity; adverse foetal effects
Species: Hamster
300 mg/kg/day Embryo-foetal development, Literature data
Result: Maternal toxicity; adverse foetal effects
Species: Mouse
ETHANOL 5 g/kg Embryo-foetal development - Oral, daily dose -
intravenous
Result: reduced foetal body weight; no malformations or
other variations
Species: Monkey
CODEINE PHOSPHATE 50 - 50 mg/kg/day Embryo-foetal development, Literature dat
a Result: Foetal toxicity, malformations, increased resorptions
Species: Hamster
ETHANOL 7 - 17 g/kg Embryo-foetal development - Oral, daily dose -
gavage
Species: Rat
Organ: skeletal malformations, dilated renal pelves
Embryo-foetal development - Oral, 15-30% in diet
Result: resorptions, neural defects, cardiac malformations
Species: Mouse
Embryo-foetal development - Oral, Causation is linked to
excessive consumption.
Species: Human
Organ: growth deficiency, CNS dysfunction, facial defects,
major organ malformation
CODEINE PHOSPHATE Embryo-foetal development, Literature data
Result: No malformtions.
Species: Rabbit
ETHANOL Embryofetal Development, in utero - 36% total calories
Species: Rat
Organ: gonadal growth and development
Fertility, Female, 10% in drinking water
Result: Negative
Species: Rat
Fertility, Female, 20-25% total calories
Result: Negative
Species: Rat
Fertility, Male, 5-6% v/v liquid diet
Species: Mouse
Organ: significant effects on testes and seminal vesicles
Test Duration: 70 Day
Specific target organ toxicity - Based on available data, the classification criteria are not met.
single exposure
CODEINE PHOSPHATE Result: Narcosis
Organ: Central Nervous System.

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Specific target organ toxicity - Not classified.
repeated exposure
Aspiration hazard Not an aspiration hazard.
Chronic effects Prolonged inhalation may be harmful.
Further information Caution - Pharmaceutical agent. Occupational exposure to the substance or mixture may cause
adverse effects.

12. Ecological information

Ecotoxicity Not expected to be harmful to aquatic organisms.
Components Species Test Results
CODEINE PHOSPHATE (CAS 52-28-8)
Aquatic
Acute
Algae EC50 Algae 10 - 100 mg/l, 96 hours QSAR Estimate
Crustacea EC50 Water flea (Daphnia pulex) 63 mg/l, 24 hours Nominal
Fish EC50 Fish 1 - 10 mg/l, 96 hours QSAR Estimate
ETHANOL (CAS 64-17-5)
Aquatic
Acute
Algae EC50 Blue-green algae (Microcystis 1450 mg/L, 72 hours
aeruginosa)
Crustacea EC50 Water flea (Daphnia magna) 9190 mg/L, 48 hours Static test
Fish EC50 Fathead minnow (Adult Pimephales 14200 mg/L, 96 hours Flow-through test
promelas)
Rainbow trout (Adult Salmo gairdneri) 13000 mg/L, 96 hours Static test
PSEUDOEPHEDRINE HYDROCHLORIDE (CAS 345-78-8)
Acute
IC50 Activated sludge > 100 mg/l, 3 hours
NOEC Activated sludge 3.2 mg/l, 3 hours
Aquatic
Acute
Algae EC50 Green algae (Selenastrum 82 mg/l, 72 hours
capricornutum)
Crustacea EC50 Water flea (Daphnia magna) > 120 mg/l, 48 hours Static test
NOEC Water flea (Daphnia magna) 7.5 mg/l, 48 hours Static test
Fish EC50 Golden ide/orfe (Juvenile Leuciscus 460 - 1000 mg/l, 96 hours
idus)
Chronic
Algae NOEC Green algae (Selenastrum > 7.5 mg/l, 72 hours
capricornutum)
TRIPROLIDINE HYDROCHLORIDE MONOHYDRATE (CAS 6138-79-0)
Acute
IC50 Activated sludge > 100 mg/l, 3 hours Nominal
Aquatic
Acute
Algae EC50 Green algae (Selenastrum 0.72 mg/l, 72 hours Measured
capricornutum)
NOEC Green algae (Selenastrum 0.47 mg/l, 72 hours Measured
capricornutum)
Crustacea EC50 Water flea (Daphnia magna) 24.2 mg/l, 48 hours Measured
NOEC Water flea (Daphnia magna) 3.8 mg/l, 48 hours Measured
Fish EC50 Rainbow trout (Juvenile Oncorhyncus 3 mg/l, 96 hours
mykiss)

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 Components Species Test Results
Chronic
Crustacea LOEC Water flea (Ceriodaphnia dubia) 1.8 mg/l, 7 days Nominal
NOEC Daphnia 1 mg/l

* Estimates for product may be based on additional component data not shown.
Persistence and degradability
Photolysis
Half-life (Photolysis-aqueous)
ETHANOL 1 - 36.6 Years Measured
Half-life (Photolysis-atmospheric)
ETHANOL 4 - 5.9 Days Estimated
Hydrolysis
Half-life (Hydrolysis-neutral)
PSEUDOEPHEDRINE HYDROCHLORIDE > 99 %, 14 days, Activated sludge
Biodegradability
Percent degradation (Aerobic biodegradation-ready)
PSEUDOEPHEDRINE HYDROCHLORIDE 60 % BOD20
TRIPROLIDINE HYDROCHLORIDE MONOHYDRATE 12 %, 28 days
Bioaccumulative potential
Partition coefficient n-octanol / water (log Kow)
CODEINE PHOSPHATE 1.14 (Measured).
ETHANOL -0.31
GLYCERIN -1.76
PSEUDOEPHEDRINE HYDROCHLORIDE 0.89
SUCROSE -3
TRIPROLIDINE HYDROCHLORIDE MONOHYDRATE 3.92
Bioconcentration factor (BCF)
TRIPROLIDINE HYDROCHLORIDE MONOHYDRATE 8 Calculated
Mobility in soil
Adsorption
Sludge/biomass distribution coefficient - log Kd
PSEUDOEPHEDRINE HYDROCHLORIDE < -1.39 Measured
TRIPROLIDINE HYDROCHLORIDE MONOHYDRATE 2.11 Measured, pH 7
Soil/sediment sorption - log Koc
ETHANOL 1.2 Calculated
TRIPROLIDINE HYDROCHLORIDE MONOHYDRATE 1.59 Calculated, pH 7
Mobility in general
Volatility
Henry's law
ETHANOL 0.000005 atm m3/mol Measured
SUCROSE < 0 atm m^3/mol Estimated
Distribution
Octanol/water distribution coefficient log DOW
CODEINE PHOSPHATE 0.61, pH 7.4
Other adverse effects Not available.

13. Disposal considerations

Disposal instructions
Local disposal regulations
Hazardous waste code
Waste from residues / unused
products
Collect and reclaim or dispose in sealed containers at licensed waste disposal site. Do not
discharge into drains, water courses or onto the ground. Dispose in accordance with all applicable
regulations.
Dispose in accordance with all applicable regulations.
The waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Dispose of in accordance with local regulations. Empty containers or liners may retain some
product residues. This material and its container must be disposed of in a safe manner (see:
Disposal instructions). Avoid discharge into water courses or onto the ground.

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Contaminated packaging Since emptied containers may retain product residue, follow label warnings even after container is
emptied. Empty containers should be taken to an approved waste handling site for recycling or
disposal.

14. Transport information

IATA
Not regulated as dangerous goods.
IMDG
Not regulated as dangerous goods.
Transport in bulk according to Not established.
Annex II of MARPOL 73/78 and
the IBC Code

15. Regulatory information

Canadian regulations
Controlled Drugs and Substances Act
CODEINE PHOSPHATE (CAS 52-28-8) 1(2)
Export Control List (CEPA 1999, Schedule 3)
Not listed.
Greenhouse Gases
Not listed.
Precursor Control Regulations
Not regulated.
International regulations
Stockholm Convention
Not applicable.
Rotterdam Convention
Not applicable.
Kyoto protocol
Not applicable.
Montreal Protocol
Not applicable.
Basel Convention
Not applicable.
International Inventories
Country(s) or region Inventory name On inventory (yes/no)*
Australia Australian Inventory of Chemical Substances (AICS) No
Canada Domestic Substances List (DSL) No
Canada Non-Domestic Substances List (NDSL) No
China Inventory of Existing Chemical Substances in China (IECSC) No
Europe European Inventory of Existing Commercial Chemical No
Substances (EINECS)
Europe European List of Notified Chemical Substances (ELINCS) No
Japan Inventory of Existing and New Chemical Substances (ENCS) No
Korea Existing Chemicals List (ECL) No
New Zealand New Zealand Inventory No
Philippines Philippine Inventory of Chemicals and Chemical Substances No
(PICCS)
United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory No
*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)
A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing
country(s).

16. Other Information

Issue date 06-01-2016
Revision date 06-01-2016
Version # 04
Material name: ACTIFED COMPOUND LINCTUS SDS CANADA

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References GSK Hazard Determination
Disclaimer The information and recommendations in this safety data sheet are, to the best of our knowledge,
accurate as of the date of issue. Nothing herein shall be deemed to create any warranty, express
or implied. It is the responsibility of the user to determine the applicability of this information and
the suitability of the material or product for any particular purpose.
Revision information Product and Company Identification: Product and Company Identification
Composition / Information on Ingredients: Ingredients
Physical & Chemical Properties:
Ecological Information: Ecotoxicity

Material name: ACTIFED COMPOUND LINCTUS SDS CANADA

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