Drixoral Day / Night Cold (Dexbrompheniramine – Pseudoephedrine Sulfate)

DRIXORAL® DAY/NIGHT Cold Relief System

Schering

Dexbrompheniramine – Pseudoephedrine Sulfate

Antihistamine – Decongestant

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, chronic lung disease, 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.

Occupational Hazards: Dexbrompheniramine maleate may cause drowsiness which may impair ability to drive or perform other tasks requiring alertness.

Since the depressant effects of antihistamines are additive to those of other drugs affecting the CNS, caution patients against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant effects during antihistaminic therapy.

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.

Antihistamines should be discontinued approximately 48 hours prior to skin testing procedures since these may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

Adverse Reactions: Mild drowsiness and skin rash have been observed in occasional patients receiving Drixoral Night.

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: Dexbrompheniramine maleate: sedation, lassitude, muscular weakness, palpitations, dry mouth, gastrointestinal disturbances, dermatitis.

Pseudoephedrine: 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 And Administration: Drixoral Day (Drixoral N.D. yellow tablet): Adults and children 12 years and over: 1 tablet in morning.

Drixoral Night (Drixtab white tablet): Adults and children 12 years and over: 1 tablet at bedtime.

Availability And Storage: Drixoral Day/Night Cold Relief System: Each daytime 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.

Each nighttime white tablet contains: dexbrompheniramine maleate USP 2 mg and pseudoephedrine sulfate USP 60 mg. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate and povidone. Tartrazine-free.

Boxes of 10 and 20.

DRIXORAL® DAY/NIGHT Cold Relief System Schering Dexbrompheniramine – Pseudoephedrine Sulfate Antihistamine – Decongestant

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Allergic Rhinitis

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Otitis Media

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