FDA records indicate that there are no current recalls for this drug.
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Dexchlorpheniramine Maleate Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
Antihistamines should be used with considerable caution in patients with:
- Narrow angle glaucoma
- Stenosing peptic ulcer
- Pyloroduodenal obstruction
- Symptomatic prostatic hypertrophy
- Bladder neck obstruction
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.
Dexchlorpheniramine Maleate, USP has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).
Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.
Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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).
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.
Sources
Dexchlorpheniramine Maleate Solution Manufacturers
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Morton Grove Pharmaceuticals, Inc.
Dexchlorpheniramine Maleate Solution | Morton Grove Pharmaceuticals, Inc.
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.
Recommended DosageAdults 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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