SDS

SAFETY DATA SHEET
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11. TOXICOLOGICAL INFORMATION
Acute Toxicity Comments:
A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable
at the highest dose used in the test.
Irritation / Sensitization: (Study Type, Species, Severity)
Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)
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PZ01360
Glycerin, USP
Mouse Oral LD50 120mg/kg
Eye Irritation Rabbit Mild
Revision date: 17-Sep-2015
Sodium lauryl sulfate
Hydroxypropyl methylcellulose
Eye Irritation Rabbit Moderate
Ibuprofen
Skin Irritation Rabbit Mild Moderate
Rat Oral LD50 > 10,000 mg/kg
Material Name: Advil Congestion Relief Tablets
Skin Sensitization - GPMT Guinea Pig Negative
Skin Sensitization - LLNA Mouse Negative
Microcrystalline cellulose
Microcrystalline cellulose
Rat Oral LD 50 1600 mg/kg
Skin Irritation Rabbit Non-irritating
Rat Oral LD50 > 5000 mg/kg
Version: 2.2
Eye Irritation Rabbit Non-irritating
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Rabbit Dermal LD50 > 2000 mg/kg
Stearic acid
Rat Inhalation LC 50
> 20mg/L
30 Week(s) Rat Oral 300 ppm LOAEL Adipose tissue
Talc (non-asbestiform)
Ibuprofen
Phenylephrine hydrochloride
4 Day(s) Rat Oral 200 mg/kg Gastrointestinal System
Stearic acid
30 Day(s) Dog Oral 480 mg/kg Gastrointestinal system
2 Week(s) Rat Oral 1300 mg/kg Liver
Skin Irritation Rabbit Moderate
Rat Oral LD50 350 mg/kg
Eye Irritation Rabbit Mild
Rat Oral LD50 > 1600 mg/kg