POLMON (Dexchlorpheniramine Maleate Oral Solution, USP)

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 C ₁₆H ₁₉ClN ₂ • C ₄H ₄O ₄, designated chemically as (+)-2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1).

Dexchlorpheniramine Maleate

M.W. = 390.86

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

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.

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.

Use in Newborn or Premature Infants
This drug should not be used in newborn or premature infants.

Antihistamines should be used with considerable caution in patients with:

• Narrow angle glaucoma
  Stenosing peptic ulcer
  Pyloroduodenal obstruction
  Symptomatic prostatic hypertrophy
  Bladder neck obstruction

POLMON Oral Solution 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

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.

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.

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

Recommended Dosage

Adults and Children 12 years of age and older: 2 mg (1 teaspoonful)

Children 6 to 11 years: 1 mg (1/2 teaspoonful)

Children 2 to 5 years: 0.5 mg (1/4 teaspoonful)

Doses are generally given every 4 to 6 hours.

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

4 fl oz. Bottle Label

NDC 64543-600-04

POLMON
(dexchlorpheniramine maleate oral solution, USP)
2 mg per 5 mL

Rx Only

4 fl oz. (118 mL)

USUAL DOSAGE: See Package Insert for Complete Dosage Recommendations.
Dispense in a tight, light-resistant container with a child-resistant closure.

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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

Tamper evident by foil seal under cap. Do not use if inner foil seal is broken or missing.

Manufactured for:
Capellon Pharmaceuticals, LLC
Fort Worth, TX 76118

16 fl oz. Bottle Label

NDC 64543-600-16

POLMON
(dexchlorpheniramine maleate oral solution, USP)
2 mg per 5 mL

Rx Only

16 fl oz. (473 mL)

USUAL DOSAGE: See Package Insert for Complete Dosage Recommendations.
Dispense in a tight, light-resistant container with a child-resistant closure.

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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

Tamper evident by foil seal under cap. Do not use if inner foil seal is broken or missing.

Manufactured for:
Capellon Pharmaceuticals, LLC
Fort Worth, TX 76118