SDS

SAFETY DATA SHEET
_______________________________________________________________________________________________________
10. STABILITY AND REACTIVITY
Incompatible Materials:
As a precautionary measure, keep away from strong oxidizers
Hazardous Decomposition
Products:
No data available
11. TOXICOLOGICAL INFORMATION
Information on Toxicological Effects
General Information:
The information included in this section describes the potential hazards of the individual
ingredients.
Short Term:
Accidental ingestion may cause effects similar to those seen in clinical use. Acute overdosage
and/or chronic abuse of ibuprofen may cause kidney effects.
Long Term:
Animal studies indicate that this material may cause adverse effects on the fertility , the
developing fetus.
Known Clinical Effects:
Adverse effects associated with therapeutic use include gastrointestinal effects such as
nausea, pain, heartburn, bleeding, ulceration, and perforation . Adverse effects associated with
the therapeutic use of phenylephrine hydrochloride include fast or irregular heart rate,
increased blood pressure, anxiety, restlessness, headache, difficulty breathing, and
gastrointestinal disturbances. Systemic side-effects have occurred following the use of
phenylephrine eye drops and nasal drops. It may also cause prolonged bleeding time. Other
nonsteroidal anti-inflammatory drugs (NSAIDs) are known to impact delivery, late fetal
development, and lactation.
Acute Toxicity: (Species, Route, End Point, Dose)
_______________________________________________________________________________________________________
PZ01360
Revision date: 17-Sep-2015
Xanthan gum
Lecithin
Rat Oral LD50 > 5000 mg/kg
Material Name: Advil Congestion Relief Tablets
Glycerin, USP
Rat Oral LD50 > 8 ml/kg
Mouse Oral LD50 4090 mg/kg
Stearic acid
Rat Oral LD50 12.6 g/kg
Titanium dioxide
Rabbit Dermal LD50 > 10 g/kg
Version: 2.2
Rat Inhalation LC50 1hr > 570 mg/m
3
Rat Oral LD50 > 7500 mg/kg
Rat Dermal LD 50 > 21.9 g/kg
Rat Oral LD50 > 4640 mg/kg
Sodium lauryl sulfate
Rat Subcutaneous LD50 50 mg/kg
Rat Oral LD50 1288 mg/kg
Page 9 of 17
Triacetin
Rabbit Dermal LD50 > 5000mg/kg
Mouse Oral LD50 1100 mg/kg