Advil WH-0432-0033, WH-0432-0037 User Manual

SAFETY DATA SHEET

Revision date: 30-Mar-2015

Version: 2.1

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

Product Identifier

Material Name: Advil Tablets/Caplets

Trade Name:
Compound Number:
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-0432-0033, -0037
Not determined

Consumer healthcare product used as non-steroidal, anti-inflammatory drug (nsaid)

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

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

2. HAZARDS IDENTIFICATION

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Classification of the Substance or Mixture

GHS - Classification

Acute Oral Toxicity: Category 4
Reproductive Toxicity: Category 2

EU Classification:

EU Indication of danger: Harmful

Toxic to Reproduction: Category 3

EU Risk Phrases:

R22 - Harmful if swallowed.
R63 - Possible risk of harm to the unborn child.

Label Elements

Signal Word:
Hazard Statements:

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PZ01658

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

SAFETY DATA SHEET

Material Name: Advil Tablets/Caplets
Revision date: 30-Mar-2015

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Precautionary Statements:

Other Hazards
Australian Hazard Classification
(NOHSC):

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

No data available
Hazardous Substance. Non-Dangerous Goods.

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Version: 2.1

Note:

This document has been prepared in accordance with standards for workplace safety, which
requires the inclusion of all known hazards of the product or its ingredients regardless of the
potential risk. The precautionary statements and warning included may not apply in all cases.
Your needs may vary depending upon the potential for exposure in your workplace.

3. COMPOSITION / INFORMATION ON INGREDIENTS

Hazardous

Ingredient CAS Number EU

EINECS/ELINCS

List

Colloidal silicon dioxide 7631-86-9 231-545-4 Not Listed Not Listed *
Corn Starch 9005-25-8 232-679-6 Not Listed Not Listed *
Ibuprofen 15687-27-1 239-784-6 Repr.Cat3;R62-63

Microcrystalline cellulose 9004-34-6 232-674-9 Not Listed Not Listed *
Sodium lauryl sulfate 151-21-3 205-788-1 Not Listed Not Listed *
Starch, pregelatinized 9005-25-8 232-679-6 Not Listed Not Listed *
Sucrose 57-50-1 200-334-9 Not Listed Not Listed *
Titanium dioxide 13463-67-7 236-675-5 Not Listed Not Listed *

Ingredient CAS Number EU

EINECS/ELINCS

List

Acetylated monoglycerides 308068-38-4 Not Listed Not Listed Not Listed *
Beeswax 8012-89-3 232-383-7 Not Listed Not Listed *
Croscarmellose sodium 74811-65-7 Not Listed Not Listed Not Listed *
Methylparaben 99-76-3 202-785-7 Not Listed Not Listed *
Pharmaceutical glaze Not assigned Not Listed Not Listed Not Listed *
Pharmaceutical ink Not assigned Not Listed Not Listed Not Listed *

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PZ01658

EU Classification GHS

Classification

Acute Tox.4 (H302)

Xn;R22

EU Classification GHS

Repr.2 (H361fd)

Classification

40-45

%

%

SAFETY DATA SHEET

Material Name: Advil Tablets/Caplets
Revision date: 30-Mar-2015

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Povidone 9003-39-8 Not Listed Not Listed Not Listed *
Propylparaben 94-13-3 202-307-7 Not Listed Not Listed *
Sodium benzoate 532-32-1 208-534-8 Not Listed Not Listed *
Stearic acid 57-11-4 200-313-4 Not Listed Not Listed *
Synthetic iron oxide 1332-37-2 215-570-8 Not Listed Not Listed *

Additional Information:

For the full text of the R phrases and 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: 2.1

4. FIRST AID MEASURES

Description of First Aid Measures

Eye Contact:

Skin Contact:

Flush eye(s) immediately with plenty of water. If irritation occurs or persists, get medical
attention.

Due to the nature of this material first aid is not normally required. If irritation occurs or
persists, get medical attention.

Ingestion:

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:

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.

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.

Not applicable

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.

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PZ01658

SAFETY DATA SHEET

Material Name: Advil Tablets/Caplets
Revision date: 30-Mar-2015

Page 4 of 15

Version: 2.1

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Methods and Material for Containment and Cleaning Up

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 as Non-steroidal, anti-inflammatory 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:

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

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

Listed

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

3
3

3
3

3

3
3
3

3

3

3

3

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PZ01658

SAFETY DATA SHEET

Material Name: Advil Tablets/Caplets
Revision date: 30-Mar-2015

Page 5 of 15

Version: 2.1

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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

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

10 mg/m
4 mg/m

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

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
3
3

3

3

3

3

3

Sodium lauryl sulfate

Pfizer OEL TWA-8 Hr:

Starch, pregelatinized

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

Ireland OEL - TWAs

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

Sucrose

ACGIH Threshold Limit Value (TWA)
Australia TWA
Belgium OEL - TWA

0.3 mg/m³

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

10.0 mg/m

4.0 mg/m
10 mg/m

5 mg/m
10 mg/m

4 mg/m

3

3

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

3

10 mg/m
3 mg/m

3

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

3
3
3

3

3

3

3

3
3

3

3
3
3

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PZ01658