IRUDEN Phenylephrine Hydrochloride / Brompheniramine Maleate 6.25mg / 2mg per mL Syrup (Oral Drops) 15mL Grape
NONRXDRUG-DRP-2910-02
Discreet Packaging
FDA-licensed Pharmacies
Indications/Uses
Treatment of common colds and allergic rhinitis.
Dosage/Direction for Use
Syrup: Adults: 5-10 mL (1 to 2 teaspoonfuls) every 6 to 8 hours, or as prescribed by the physician.
Children: 1-6 months: 1.25 mL (¼ teaspoon); 7 months-2 years: 2.5 mL (½ teaspoon); 3-4 years: 3.75 mL (¾ teaspoon); 5-12 years: 5 mL (1 teaspoon).
To be given every 6 to 8 hours, or as prescribed by the physician.
Infant Drops: Up to 6 months: 0.5 mL; 7 months-2 years: 1 mL.
To be given every 6 to 8 hours, or as prescribed by the physician.
Children: 1-6 months: 1.25 mL (¼ teaspoon); 7 months-2 years: 2.5 mL (½ teaspoon); 3-4 years: 3.75 mL (¾ teaspoon); 5-12 years: 5 mL (1 teaspoon).
To be given every 6 to 8 hours, or as prescribed by the physician.
Infant Drops: Up to 6 months: 0.5 mL; 7 months-2 years: 1 mL.
To be given every 6 to 8 hours, or as prescribed by the physician.
Contraindications
Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, in patients with severe hypertension or severe coronary artery disease, or in those receiving monoamine oxidase (MAO) inhibitors.
Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Special Precautions
Caution should be exercised in patients with high blood pressure, heart disease, diabetes or thyroid disease. The antihistamine in this product may exhibit additive effects with other CNS depressants, including alcohol.
Antihistamine may cause drowsiness and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly.
MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the hypertensive effects of methyldopa, mecamylamine, reserpine and veratum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect. The safety of use of this product in pregnancy has not been established.
Antihistamine may cause drowsiness and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly.
MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the hypertensive effects of methyldopa, mecamylamine, reserpine and veratum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect. The safety of use of this product in pregnancy has not been established.
Use In Pregnancy & Lactation
The safety of use of this product in pregnancy has not been established.
Adverse Reactions
Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of the mouth, blurred vision, cardiac palpitations, flushing, increased irritability, or excitement (especially in children).
Drug Interactions
Additive effect w/ other CNS depressants including alcohol. Increased sympathomimetic effects w/ MAOIs & β-adrenergic blockers. Reduce hypertensive effects of methyldopa, mecamylamine, reserpine & veratum alkaloids.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Brompheniramine maleate is a histamine antagonist, specifically an H1-receptor blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells.
Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistamine effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue.
Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after a single oral dose of 4 mg reached in 5 hours, urinary excretion is the major route of elimination mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.
Phenylephrine hydrochloride is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors. It therefore functions as an oral nasal decongestant with minimal central nervous system (CNS) stimulation.
Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistamine effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue.
Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after a single oral dose of 4 mg reached in 5 hours, urinary excretion is the major route of elimination mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.
Phenylephrine hydrochloride is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors. It therefore functions as an oral nasal decongestant with minimal central nervous system (CNS) stimulation.
MedsGo Class
Cough & Cold Preparations / Antihistamines & Antiallergics
Features
Brand
Iruden
Full Details
Dosage Strength
6.25mg / 2mg perml
Drug Ingredients
- Brompheniramine Maleate
- Phenylephrine
Drug Packaging
Syrup (Oral Drops) 15ml
Generic Name
Phenylephrine Hydrochloride / Brompheniramine Maleate
Dosage Form
Syrup (Oral Drops)
Registration Number
DRP-2910-02
Drug Classification
Over-The-Counter (OTC)
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