Dexchlorpheniramine Prescribing Information

Dexchlorpheniramine Description

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.

Dexchlorpheniramine - Clinical Pharmacology

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.

Indications and Usage for Dexchlorpheniramine

Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
Amelioration of allergic reactions to blood or plasma
Dermographism

As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

Contraindications

Warnings

Antihistamines should be used with considerable caution in patients with:

Narrow angle glaucoma

Stenosing peptic ulcer

Pyloroduodenal obstruction

Symptomatic prostatic hypertrophy

Bladder neck obstruction

Precautions

Dexchlorpheniramine Maleate Oral Solution, USP has an atropine-like action and, therefore, should be used with caution in patients with:

History of bronchial asthma
Increased intraocular pressure Hyperthyroidism
Cardiovascular disease
Hypertension

Adverse Reactions/Side Effects

1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and the throat.
2. Cardiovascular System: Hemolytic anemia, thrombocytopenia, agranulocytosis.
3. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.
4. 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.
5. G.I. System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
6. G.U. System: Urinary frequency, difficult urination, urinary retention, early menses.
7. Respiratory System: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

Call your doctor for medical advice about side effects. You may voluntarily report side effects to FDA at 1-800-FDA-1088. Questions or comments? Call Foxland Pharmaceuticals, Inc. at 1-844-430-7499.

Overdosage

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 Dosage and Administration

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

How is Dexchlorpheniramine supplied

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

4 fl oz (118 mL), NDC 69067-102-04
16 fl oz (473 mL), NDC 69067-102-16

Rx Only

Manufactured for:
Foxland Pharmaceuticals, Inc.
Trussville, AL 35173

Rev. 10/18
500507-02

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 69067-102-04

Dexchlorpheniramine
Maleate
Oral Solution, USP

2 mg/5 mL

CHERRY FLAVOR

4 fl. oz (118 mL)
Rx Only

Foxland
PHARMACEUTICALS, INC.