Indications And Clinical Uses: Symptomatic relief of upper respiratory mucosal congestion in seasonal and perennial nasal allergies, acute rhinitis and rhinosinusitis, acute and subacute sinusitis, eustachian tube blockage and secretory otitis media.
Contra-Indications: Patients receiving or having received MAO inhibitors in the preceding 2 weeks; known hypersensitivity to pressor amines or antihistamines.
Precautions: Although pseudoephedrine causes practically no pressor effect in normotensive individuals, it should be used with caution in elderly persons, patients with hypertension, diabetes, latent or clinically recognized angle closure glaucoma, coronary artery disease, congestive heart failure, urinary retention, prostatic hypertrophy and hyperthyroidism and patients receiving MAO inhibitors. Pseudoephedrine sulfate may cause nervousness, restlessness or insomnia.
Should not be used by persons who are allergic or sensitive to any of the components of the product.
Pregnancy and Lactation: The safe use of this product during pregnancy and lactation has not been established and therefore the compound should be used only if the potential benefit justifies the potential risk to the fetus or infant.
Adverse Reactions: Other known possible adverse effects of sympathomimetic (i.e., pseudoephedrine) origin include anxiety, tension, restlessness, nervousness, tremor, weakness, insomnia, headache, palpitation, tachycardia, angina, elevated blood pressure, sweating, mydriasis, anorexia, nausea, vomiting, dizziness, constipation and dysuria due to vesicle sphincter spasm.
Symptoms And Treatment Of Overdose: If accidental overdose occurs, seek medical assistance immediately.Symptoms: Nervousness, insomnia, headaches, palpitations, nausea, vomiting, precordial pain.
Treatment: No specific antidote. Follow the established principles of treatment of any drug overdosage. Specific therapy will depend on the predominant symptoms observed.
Dosage: Drixoral N.D.: Adults and children 12 years and over: 1 tablet every 12 hours. Not to exceed 2 tablets in 24 hours. Do not exceed the recommended dosage without consulting a physician. Do not chew tablets, swallow whole.
Availability And Storage: Each yellow, sustained action tablet contains: pseudoephedrine sulfate USP 120 mg. Nonmedicinal ingredients: acacia, carnauba wax, calcium sulfate, castor oil hydrogenated flakes, dye Opalux yellow AS-2183, ethyl cellulose, gelatin, gum rosin, magnesium stearate, oleic acid, soap powder-white neutral, sucrose, talc, white wax and zein F-200. Blister packs of 10.
DRIXORAL® N.D. Schering Pseudoephedrine Sulfate Decongestant
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