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).
Inactive Ingredients: Citric Acid; Dehydrated Alcohol; FD&C Red No. 40; Glycerin; Liquid Sugar; Menthol; Methylparaben; Natural and Artificial Orange Juice Flavor; Propylene Glycol; Propylparaben and Purified Water. May also contain Sodium Citrate for pH adjustment. The pH range is between 5.0 and 6.5.
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
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.
Use in Nursing Mothers
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:
Hypersensitivity to dexchlorpheniramine maleate or other antihistamines of similar chemical structure
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.
DOSAGE AND ADMINISTRATION
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.
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.
Dexchlorpheniramine Maleate Oral Solution, USP 2 mg/5 mL is supplied as a red-orange colored, orange flavored liquid in the following sizes:
4 fl oz (118 mL) 16 fl oz (473 mL) 128 fl oz (3785 mL)
Store at 20 °–25 °C (68 °–77 °F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.
Product No.: 8539
Manufactured By: Morton Grove Pharmaceuticals, Inc. Morton Grove, IL 60053