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Hazard statements (CLP)

H318, H341, H350, H360, H362, H373

Code

Statements

H318

Causes serious eye damage

2.1 Classification of the substance or mixture

OSHA Regulatory Status This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Serious eye damage/eye irritation Category 1 Germ cell mutagenicity Category 2 Carcinogenicity Category 1A Reproductive toxicity Category 1B Effects on or via lactation Yes Specific target organ toxicity (repeated exposure) Category 2

2.2 Label elements

Emergency Overview Danger

Hazard statements

H318 - Causes serious eye damage H341 - Suspected of causing genetic defects H350 - May cause cancer H360 - May damage fertility or the unborn child H362 - May cause harm to breast-fed children H373 - May cause damage to organs through prolonged or repeated exposure Appearance Tablet Physical state Solid Odor No information available Chemical Name Symptoms Norethindrone Acetate Common adverse effects from the therapeutic use of this product are weight gain, nausea, edema, and acne. These effects may also be experienced from occupational exposure. Additional effects include blood coagulation, swelling, changes in weight, jaundice, headache, migraine, mood swings, depression, insomnia, and optic nerve inflammation (which can lead to partial or complete vision loss). Ethinyl Estradiol The most common effects from therapeutic use of products containing Ethinyl Estradiol are headache, menstrual disorder, breast pain, abdominal pain, nausea, flu syndrome, acne, vaginal moniliasis, depression, diarrhea, asthenia, dysmenorrhea, back pain, infection, pharyngitis, inter-menstrual bleeding, migraine, vomiting, dizziness, nervousness, vaginitis, sinusitis, cystitis, bronchitis, gastroenteritis, allergic reaction, urinary tract infection, pruritus, emotional lability, rash, upperrespiratory infection. Chronic toxicity increases the risk of cardiovascular disease, including myocardial infarction,cerebrovascular disease, thromboembolic disease, gallbladder disease, and certain cancers in some people. Chronic toxicity from Ethinyl Estradiol, like other estrogens, increases the risk for stroke, myocardial infarction and thromboembolic disease in certain populations. Jaundice, hypertension, nasal congestion, headache, dizziness and fluid retention may occur. Endometrial, breast, and certain liver cancers may occur at a higher incidence than the general population. Donepezil HCL The most common symptoms seen in therapeutic use include: nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue and anorexia. Memantine Hydrochloride Most common are dizziness, headache, confusion and constipation Chemical Name

Medical Conditions Generally Aggravated by Exposure

Norethindrone Acetate In therapeutic use, dermatitis and other skin disorders as well as menstrual disorders, pre-diabetic and diabetic conditions, heart disease, liver disorders, and benign or malignant liver tumors may be aggracted by exposure to this product. Persons handling the product in the workplace may experience adverse reaction under the same conditions. Ethinyl Estradiol Pre-existing skin conditions may be aggravated by repeated overexposures to this compound. This compound should not be used when pregnant. The following preexistingconditions may be aggravated by therapeutic doses of this compound: adrenal gland problems, heart disease, high blood pressure, breast cancer, diabetes, kidney/eye/nerve/blood vessel disease, severe headaches/migraines, heart disease, liver conditions and gallbladder disease. Donepezil HCL When administered for therapeutic use, pre-existing asthma,ulcers, cardiac abnormalities, hepatic, bladder and neurological conditions may be aggravated by exposure Memantine Hydrochloride Contraindication include hypersensitivity to any component of this product hepatic impairment

Precautionary statements

P280 - Wear eye protection/ face protection P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing P310 - Immediately call a POISON CENTER or doctor/physician P202 - Do not handle until all safety precautions have been read and understood P281 - Use personal protective equipment as required P405 - Store locked up P201 - Obtain special instructions before use P260 - Do not breathe dusts or mists P263 - Avoid contact during pregnancy/while nursing P264 - Wash face, hands and any exposed skin thoroughly after handling P270 - Do not eat, drink or smoke when using this product P308 + P313 - IF exposed or concerned: Get medical advice/attention P260 - Do not breathe dust/fume/gas/mist/vapors/spray P314 - Get medical advice/attention if you feel unwell P501 - Dispose of contents/ container to an approved waste disposal plant

Further information

Unknown Acute Toxicity 2% of the mixture consists of ingredient(s) of unknown toxicity Over the counter drugs in their solid form are considered exempt under the criteria of the Federal OSHA Hazard Communication Standard 20 CFR 1910.1200. However, in an industrial setting where a component's occupational exposure limit may be surpassed, than can be considered hazardous