Label: DEXCHLORPHENIRAMINE MALEATE- dexchlorpheniramine maleate solution 

  • NDC Code(s): 60432-539-16
  • Packager: Morton Grove Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 08/12

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  • SPL UNCLASSIFIED SECTION

    Rx only

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  • DESCRIPTION

    Each 5 mL (teaspoonful) contains:

    Dexchlorpheniramine Maleate, USP 2 mg
    Alcohol not more than 7.0%

    Dexchlorpheniramine Maleate, USP, an antihistamine agent, is a white, odorless crystalline powder that is freely soluble in water. The molecular formula is C16H19CIN2•C4H4O4, designated chemically as (+)-2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1).

    Chemical Structure

    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.

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  • 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.

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  • 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.

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  • CONTRAINDICATIONS

    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

      
    Monoamine oxidase inhibitor therapy (See Drug Interaction section)
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  • 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

    Use in Children

    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.

    Use in Pregnancy:

    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:

    Dexchlorpheniramine Maleate, USP 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.

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  • PRECAUTIONS

    Dexchlorpheniramine Maleate, 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

    Drug Interaction:

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

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  • ADVERSE REACTIONS

    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.
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  • 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.

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  • DOSAGE AND ADMINISTRATION

    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.

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  • HOW SUPPLIED

    Dexchlorpheniramine Maleate Oral Solution, USP 2 mg/5 mL is supplied as a red-orange colored, orange flavored liquid in the following sizes:

    16 fl oz (473 mL)

    RECOMMENDED STORAGE

    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.

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    Product No.: 8539

    Manufactured By:
    Morton Grove Pharmaceuticals, Inc.
    Morton Grove, IL 60053

    A50-8539-16

    REV. 07-05

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  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    MGP

    NDC 60432-539-16

    DEXCHLORPHENIRAMINE
    MALEATE ORAL
    SOLUTION, USP

    2 mg/5 mL

    (Contains alcohol
    not more than 7.0%)

    DO NOT USE IF INNER FOIL SEAL PRINTED "SEALED
    FOR YOUR PROTECTION" IS BROKEN OR MISSING.

    BULK CONTAINER —
    NOT FOR HOUSEHOLD USE

    Rx Only

    NET: 1 Pint (473 mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    DEXCHLORPHENIRAMINE MALEATE 
    dexchlorpheniramine maleate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60432-539
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dexchlorpheniramine Maleate (Dexchlorpheniramine) Dexchlorpheniramine Maleate 2 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE  
    GLYCERIN  
    Water  
    ALCOHOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    METHYL ALCOHOL  
    PROPYLENE GLYCOL  
    FD&C RED NO. 40  
    CAPTAN  
    ANHYDROUS CITRIC ACID  
    TRISODIUM CITRATE DIHYDRATE  
    Product Characteristics
    Color RED, ORANGE Score     
    Shape Size
    Flavor ORANGE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60432-539-16 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA088251 03/23/1984
    Labeler - Morton Grove Pharmaceuticals, Inc. (801897505)
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