Dexchlorpheniramine Maleate Oral Solution

Each 5 mL (teaspoonful) contains :

Dexchlorpheniramine Maleate, USP ............. 2 mg

Dexchlorpheniramine Maleate, USP, an antihistamine agent, is a white, odorless crystalline powder that is freely soluble in water. The molecular formula is C16H19ClN2 • C4H4O4, designated chemically as (+)-2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1).

M.W. = 390.86

Inactive Ingredients

Citric acid, cherry flavoring, FD&C Red No. 40, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, and sugar.

POLMON Oral Solution is supplied as a red colored, cherry flavored liquid in the following sizes:

4 fl oz (118 mL), NDC 64543-600-04
16 fl oz (473 mL), NDC 64543-600-16

Storage And Handling

Store at 20° to 25°C (68° to 77°F) [s ee USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.

Manufactured For: Capellon Pharmaceuticals , LLC, Fort Worth, TX 76118. Revised: Jul 2018

General

Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and the throat.

Cardiovascular System

Hemolytic anemia, thrombocytopenia, agranulocytosis.

Hematologic System

Hemolytic anemia, thrombocytopenia, agranulocytosis.

Nervous System

Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.

G.I. System

Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.

G.U. System

Urinary frequency, difficult urination, urinary retention, early menses.

Respiratory System

Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms—dry mouth, fixed, dilated pupils, flushing, and gastrointestinal symptoms may also occur.

If vomiting has not occurred spontaneously the patient should be induced to vomit. This is best done by having the patient drink a glass of water or milk after which the patient should be made to gag. Precautions against aspiration must be taken, especially in infants and children.

Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and therefore, are valuable for their action in rapid dilution of bowel content.

Stimulants should not be used.

Vasopressors may be used to treat hypotension.

Dexchlorpheniramine maleate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.