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POLMON (Dexchlorpheniramine Maleate Oral Solution, USP) | POLMON [Capellon Pharmaceuticals, LLC] | BioPortfolio

13:10 EST 27th January 2019 | BioPortfolio

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

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.

Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

Use in Lower Respiratory Disease

Antihistamines should NOT be used to treat lower respiratory tract symptoms including asthma.

Antihistamines are also contraindicated in the following conditions:

Antihistamines should be used with considerable caution in patients with:

In infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.

As in adults, antihistamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation.

Experience with this drug in pregnant women is inadequate to determine whether there exists a potential for harm to the developing fetus.

Use with CNS Depressants:

POLMON Oral Solution has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).

Use in Activities Requiring Mental Alertness:

Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

Use in the Elderly (approximately 60 years or older):

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

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

MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

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

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

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

Rx Only

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

500403-01

REV. 04/2015

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

Manufacturer

Capellon Pharmaceuticals, LLC

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