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Rate Norel® SR
Inactive Ingredients: calcium phosphate, magnesium stearate, methylcellulose, povidone, silicified microcrystalline cellulose, D&C Yellow #10, FD&C Yellow #6.
Indications
NOREL® SR is indicated for the temporary relief of allergy induced nasal congestion, runny nose, sneezing, headache and associated pain caused from inhalation of airborne antigens and other irritants.
Contraindications
NOREL® SR should not be administered to patients who have previously exhibited hypersensitivity to any of the ingredients. Risk-benefit should be considered when any of the following medical problem exist: alcoholism, asthma, bladder-neck obstruction, urinary retention, cardiovascular disease, diabetes mellitus, glaucoma, hepatic function impair, hypertension, hyperthyroidism, prostatic hypertrophy, psychosis or other psychiatric disorders, renal function impairment, viral hepatitis.
Adverse Reactions
The following adverse effects have been selected on the basis of their potential clinical significance (not necessarily inclusive): allergic reactions, anemia, blood dyscrasias (sore throat and fever, unusual bleeding or bruising, unusual tiredness or weakness), psychotic episodes (mood or mental changes) - usually associated with previous history of psychiatric illness, tightness in chest.
Dosage
Adults and children over 12 years of age: 1 tablet every 12 hours, not to exceed 2 tablets in 24 hours. Children under 12 years of age: take as directed by physician or other healthcare provider. Tablets may be broken in half for ease of administration without affecting the release of the medication, but should not be chewed or crushed prior to swallowing. Do not exceed recommended dosage.
How Supplied
Bottles of 100 (NDC 52747-420-70) yellow & white bi-layer, triangle-shaped tablets debossed "04" bisected "20" on one side, "US" on the opposite.
Warnings
If pain or fever persists, if new symptoms occur, or if redness or swelling is present, consult your physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age unless directed by a physician. Caution should be exercised when used in patients with prostatic hypertrophy, urinary retention, bladder neck obstruction, increased ocular pressure, and asthma.
Caution
Rx only.
This product information is intended for the physician and is not the entire product information. Please download the product literature for the complete product information.
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