Official product label reference
Corphena — BluCrest Pharmaceuticals LLC
This page contains 13 source sections for DEXCHLORPHENIRAMINE MALEATE, oral route. Label set 4694616b-4ef4-28a4-e063-6394a90ac5f6, version 1.
Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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.
Dosage and administration — label text
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.
Contraindications
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)
Warnings
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 CORPHENA 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.
Adverse reactions
ADVERSE REACTIONS General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and the throat. Cardiovascular System: Hemolytic anemia, thrombocytopenia, agranulocytosis. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. 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. G.I. System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. G.U. System: Urinary frequency, difficult urination, urinary retention, early menses. Respiratory System: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Call your doctor for medical advice about side effects. You may voluntarily report side effects to FDA at 1-800-FDA-1088. Questions or comments? Call BluCrest Pharmaceuticals, LLC at 1-844-700-5011.
Drug interactions
Drug Interaction MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
Unclassified section
Rx only
Rx Only Manufactured for: BluCrest Pharmaceuticals, LLC Hazlet, NJ 07730 www.blucrestpharma.com Rev. 11/2025
Product description
DESCRIPTION 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 16 H 19 ClN 2 ∙ C 4 H 4 O 4 , designated chemically as (+)-2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl] pyridine maleate (1:1). M.W. = 390.86 Inactive Ingredients: Citric acid, cherry flavoring, FD&C Red No. 40, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, and sugar. Chemical Structure
Table text from source:
| Each 5 mL (teaspoonful) contains:
| Dexchlorpheniramine Maleate, USP | 2 mg
Clinical pharmacology
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.
Precautions
PRECAUTIONS CORPHENA 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 Drug Interaction MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
Overdose information
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.
Supply and packaging
HOW SUPPLIED CORPHENA Oral Solution is supplied as a red colored, cherry flavored liquid in the following sizes: 8 fl oz (237 mL), NDC 73684-300-08 RECOMMENDED STORAGE 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.
Storage and handling
RECOMMENDED STORAGE 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.
Official sources and product identifiers
- DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
- openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.
- Drugs@FDA application ANDA202520Application history where available; verify the specific product and indication.
Substances listed: DEXCHLORPHENIRAMINE MALEATE
RxNorm identifiers: 2183907
Package NDC codes
73684-300-08
Further research and background
These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.
Coverage and corrections
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.
Source retrieved 2026-10-02. Read the source policy.