Advil WH-1233-0009 User Manual

SAFETY DATA SHEET

Revision date: 17-Sep-2015

Version: 2.2

1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKING

Product Identifier

Material Name: Advil Congestion Relief Tablets

Trade Name:
Compound Number:
Synonyms:
Chemical Family:

Relevant Identified Uses of the Substance or Mixture and Uses Advised Against

Intended Use:

Details of the Supplier of the Safety Data Sheet
Pfizer Inc
1 Giralda Farms
Madison, NJ 07940

Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300

Contact E-Mail:

[e-mail]

ADVIL
WH-1233-0009
Advil Sinus Congestion and Pain Tablets
Not determined

Consumer healthcare product used for Upper respiratory

Pfizer Ltd
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
+00 44 (0)1304 616161

Emergency telephone number:
International CHEMTREC (24 hours): [phone]

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2. HAZARDS IDENTIFICATION

Classification of the Substance or Mixture

GHS - Classification

Acute Oral Toxicity: Category 4
Reproductive Toxicity: Category 2

Label Elements

Signal Word:
Hazard Statements:

Precautionary Statements:

Warning
H302 - Harmful if swallowed
H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child.

P201 - Obtain special instructions before use
P202 - Do not handle until all safety precautions have been read and understood
P264 - Wash hands thoroughly after handling
P270 - Do not eat, drink or smoke when using this product
P281 - Use personal protective equipment as required
P301+ P312 - IF SWALLOWED: Call a POISON CENTRE or doctor/physician if you feel
unwell
P330 - Rinse mouth
P308 + P313 - IF exposed or concerned: Get medical attention/advice
P405 - Store locked up
P501 - Dispose of contents/container in accordance with all local and national regulations

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SAFETY DATA SHEET

Material Name: Advil Congestion Relief Tablets
Revision date: 17-Sep-2015

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Other Hazards
Note:

Additional Information:

No data available
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.

For a more detailed discussion of potential health hazards and toxicity see Section 11.

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3. COMPOSITION / INFORMATION ON INGREDIENTS

Hazardous

Ingredient CAS Number EU

EINECS/ELINCS

List

Colloidal silicon dioxide 7631-86-9 231-545-4 Not Listed *
Corn Starch 9005-25-8 232-679-6 Not Listed *
Glycerin, USP 56-81-5 200-289-5 Not Listed *
Ibuprofen 15687-27-1 239-784-6 Acute Tox.4 (H302)

Microcrystalline cellulose 9004-34-6 232-674-9 Not Listed *
Phenylephrine hydrochloride 61-76-7 200-517-3 Acute Tox. 4, H302 2-5
Propyl gallate 121-79-9 204-498-2 Acute Tox. 4 (H302)

Sodium lauryl sulfate 151-21-3 205-788-1 Not Listed *
Stearic acid 57-11-4 200-313-4 Not Listed *
Talc (non-asbestiform) 14807-96-6 238-877-9 Not Listed *
Titanium dioxide 13463-67-7 236-675-5 Not Listed *

GHS Classification %

45-50

Repr.2 (H361fd)

<1

Skin Sens. 1 (H317)

Ingredient CAS Number EU

EINECS/ELINCS

List

Acesulfame potassium salt 55589-62-3 259-715-3 Not Listed *
Caprylic/capric triglyceride 65381-09-1 265-724-3 Not Listed *
Carnauba wax 8015-86-9 232-399-4 Not Listed *
Croscarmellose sodium 74811-65-7 Not Listed Not Listed *
Flavor NOT ASSIGNED Not Listed Not Listed *
Hydroxypropyl methylcellulose 9004-65-3 Not Listed Not Listed *
Lactic acid 88% USP 50-21-5 200-018-0 Not Listed *
Lecithin 8002-43-5 232-307-2 Not Listed *
Maltodextrin 9050-36-6 232-940-4 Not Listed *
Pharmaceutical ink Not assigned Not Listed Not Listed *
Polydextrose 68424-04-4 Not Listed Not Listed *
Polyvinyl alcohol 9002-89-5 Not Listed Not Listed *
Sucralose 56038-13-2 259-952-2 Not Listed *
Synthetic iron oxide 1332-37-2 215-570-8 Not Listed *

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GHS Classification %

SAFETY DATA SHEET

Material Name: Advil Congestion Relief Tablets
Revision date: 17-Sep-2015

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Triacetin 102-76-1 203-051-9 Not Listed *
Xanthan gum 11138-66-2 234-394-2 Not Listed *

Additional Information:

For the full text of the CLP/GHS abbreviations mentioned in this Section, see Section 16

* Proprietary
Ingredient(s) indicated as hazardous have been assessed under standards for workplace
safety.
In accordance with 29 CFR 1910.1200, the exact percentage composition of this mixture has
been withheld as a trade secret.

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Version: 2.2

4. FIRST AID MEASURES

Description of First Aid Measures

Eye Contact:

Skin Contact:

Ingestion:

Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention
immediately.

Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek
medical attention.

Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not
induce vomiting unless directed by medical personnel. Seek medical attention immediately.

Inhalation:

Most Important Symptoms and Effects, Both Acute and Delayed

Symptoms and Effects of
Exposure:
Medical Conditions
Aggravated by Exposure:

Indication of the Immediate Medical Attention and Special Treatment Needed

Notes to Physician:

Remove to fresh air and keep patient at rest. Seek medical attention immediately.

For information on potential signs and symptoms of exposure, See Section 2 - Hazards
Identification and/or Section 11 - Toxicological Information.
None known

None

5. FIRE FIGHTING MEASURES

Extinguishing Media:
Special Hazards Arising from the Substance or Mixture

Hazardous Combustion
Products:

Fire / Explosion Hazards:

Advice for Fire-Fighters

During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.

Extinguish fires with CO2, extinguishing powder, foam, or water.

Formation of toxic gases is possible during heating or fire.

Fine particles (such as dust and mists) may fuel fires/explosions.

6. ACCIDENTAL RELEASE MEASURES

Personal Precautions, Protective Equipment and Emergency Procedures

Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.

Environmental Precautions

Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.

Methods and Material for Containment and Cleaning Up

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SAFETY DATA SHEET

Material Name: Advil Congestion Relief Tablets
Revision date: 17-Sep-2015

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Version: 2.2

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Measures for Cleaning /
Collecting:

Contain the source of spill if it is safe to do so. Collect spilled material by a method that
controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of
dry solids. Clean spill area thoroughly.

Additional Consideration for
Large Spills:

Non-essential personnel should be evacuated from affected area. Report emergency
situations immediately. Clean up operations should only be undertaken by trained personnel.

7. HANDLING AND STORAGE

Precautions for Safe Handling

Minimize dust generation and accumulation. If tablets or capsules are crushed and/or broken, avoid breathing dust and avoid
contact with eyes, skin, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash
hands and any exposed skin after removal of PPE. Releases to the environment should be avoided. Review and implement
appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or
environmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dust
collectors, HEPA filtration systems or other equivalent controls.

Conditions for Safe Storage, Including any Incompatibilities

Storage Conditions:

Specific end use(s):

Store as directed by product packaging.
Consumer healthcare product used for Upper respiratory and/or non-steroidal, anti­inflammatory drug (nsaid)

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Control Parameters

Refer to available public information for specific member state Occupational Exposure Limits.

Colloidal silicon dioxide

Australia TWA
Austria OEL - MAKs

Czech Republic OEL - TWA

Estonia OEL - TWA
Finland OEL - TWA
Germany - TRGS 900 - TWAs
Germany (DFG) - MAK
Ireland OEL - TWAs

Latvia OEL - TWA
OSHA - Final PELs - Table Z-3 Mineral D:

2 mg/m
4 mg/m

0.3 mg/m

0.1 mg/m

4.0 mg/m
2 mg/m
5 mg/m
4 mg/m
4 mg/m
6 mg/m

2.4 mg/m
1 mg/m
20 mppcf

3
3

3
3

3
3
3
3
3
3

3
3

Listed

Slovakia OEL - TWA
Switzerland OEL -TWAs

Corn Starch

ACGIH Threshold Limit Value (TWA)
Australia TWA
Belgium OEL - TWA
Bulgaria OEL - TWA
Czech Republic OEL - TWA
Greece OEL - TWA

4.0 mg/m
4 mg/m

0.3 mg/m

10 mg/m
10 mg/m
10 mg/m

10.0 mg/m

4.0 mg/m
10 mg/m

5 mg/m

3
3

3

3
3
3

3

3

3

3

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SAFETY DATA SHEET

Material Name: Advil Congestion Relief Tablets
Revision date: 17-Sep-2015

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Version: 2.2

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8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Ireland OEL - TWAs

OSHA - Final PELS - TWAs:
Portugal OEL - TWA
Slovakia OEL - TWA
Spain OEL - TWA
Switzerland OEL -TWAs

Glycerin, USP

Australia TWA
Belgium OEL - TWA
Czech Republic OEL - TWA
Estonia OEL - TWA
Finland OEL - TWA
France OEL - TWA
Germany (DFG) - MAK
Greece OEL - TWA
Ireland OEL - TWAs
OSHA - Final PELS - TWAs:
Poland OEL - TWA
Portugal OEL - TWA
Spain OEL - TWA
Switzerland OEL -TWAs

10 mg/m
4 mg/m

15 mg/m
10 mg/m
4 mg/m
10 mg/m
3 mg/m

10 mg/m
10 mg/m
10 mg/m
10 mg/m
20 mg/m
10 mg/m
50 mg/m
10 mg/m
10 mg/m
15 mg/m
10 mg/m
10 mg/m
10 mg/m
50 mg/m

3

3

3
3

3

3

3

3
3
3
3
3
3
3
3
3
3
3
3
3
3

Ibuprofen

Pfizer OEL TWA-8 Hr:

Microcrystalline cellulose

ACGIH Threshold Limit Value (TWA)
Australia TWA
Belgium OEL - TWA
Estonia OEL - TWA
France OEL - TWA
Ireland OEL - TWAs

Latvia OEL - TWA
OSHA - Final PELS - TWAs:
Portugal OEL - TWA
Romania OEL - TWA
Russia OEL - TWA
Spain OEL - TWA
Switzerland OEL -TWAs
Vietnam OEL - TWAs

Phenylephrine hydrochloride

Pfizer OEL TWA-8 Hr:

Sodium lauryl sulfate

Pfizer OEL TWA-8 Hr:

3000µg/m

10 mg/m
10 mg/m
10 mg/m
10 mg/m
10 mg/m
10 mg/m

4 mg/m
2 mg/m
15 mg/m
10 mg/m
10 mg/m
6 mg/m
10 mg/m
3 mg/m
10 mg/m

5 mg/m

3

3
3
3
3
3
3

3
3

3
3
3

3

3

3

3

3

0.04 mg/m³, Skin

0.3 mg/m³

Talc (non-asbestiform)

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SAFETY DATA SHEET

Material Name: Advil Congestion Relief Tablets
Revision date: 17-Sep-2015

Page 6 of 17

Version: 2.2

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8. EXPOSURE CONTROLS / PERSONAL PROTECTION

ACGIH Threshold Limit Value (TWA)
Australia TWA
Austria OEL - MAKs
Belgium OEL - TWA
Bulgaria OEL - TWA

Czech Republic OEL - TWA
Denmark OEL - TWA
Finland OEL - TWA
Greece OEL - TWA

Hungary OEL - TWA
Ireland OEL - TWAs

Lithuania OEL - TWA

Netherlands OEL - TWA
OSHA - Final PELs - Table Z-3 Mineral D:
Poland OEL - TWA

Portugal OEL - TWA
Romania OEL - TWA
Slovakia OEL - TWA

Slovenia OEL - TWA
Spain OEL - TWA
Sweden OEL - TWAs

Switzerland OEL -TWAs

2 mg/m

2.5 mg/m
2 mg/m
2 mg/m

1.0 fiber/cm3

6.0 mg/m

3.0 mg/m

2.0 mg/m

0.3 fiber/cm3

0.5 fiber/cm3
10 mg/m

2 mg/m
2 mg/m
10 mg/m

0.8 mg/m
2 mg/m

1 mg/m

0.25 mg/m
20 mppcf

4.0 mg/m

1.0 mg/m
2 mg/m
2 mg/m
2 mg/m

10 mg/m
2 mg/m
2 mg/m
2 mg/m

1 mg/m
2 mg/m

3

3
3
3

3

3

3

3

3
3

3

3
3

3

3

3

3
3
3
3

3
3
3
3

3
3

Titanium dioxide

ACGIH Threshold Limit Value (TWA)
ACGIH OELs - Notice of Intended Changes
Australia TWA
Austria OEL - MAKs
Belgium OEL - TWA
Bulgaria OEL - TWA
Denmark OEL - TWA
Estonia OEL - TWA
France OEL - TWA
Greece OEL - TWA

Ireland OEL - TWAs

Latvia OEL - TWA
Lithuania OEL - TWA
OSHA - Final PELS - TWAs:
Poland OEL - TWA
Portugal OEL - TWA
Romania OEL - TWA
Russia OEL - TWA
Spain OEL - TWA

10 mg/m
Listed
10 mg/m
5 mg/m
10 mg/m

10.0 mg/m
6 mg/m
5 mg/m
10 mg/m
10 mg/m

5 mg/m
10 mg/m

4 mg/m
10 mg/m
5 mg/m
15 mg/m

10.0 mg/m
10 mg/m
10 mg/m
10 mg/m
10 mg/m

3

3
3

3

3
3
3

3
3

3

3

3

3

3

3

3

3
3
3
3

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