Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED RYCLORA™ Oral Solution is supplied as a red colored, cherry flavored liquid in the following sizes: 4 fl oz (118 mL), NDC 15370-150-04 16 fl oz (473 mL), NDC 15370-150-16 0.7 fl oz (20mL), NDC 15370-150-99 (as physician sample) 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.; PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 15370-150-16 RyClora™ (dexchlorpheniramine maleate) Oral Solution, USP 2 mg/5 mL Cherry Flavor Rx Only 16 fl. oz (473 mL) carwin PHARMACEUTICAL ASSOCIATES PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
- HOW SUPPLIED RYCLORA™ Oral Solution is supplied as a red colored, cherry flavored liquid in the following sizes: 4 fl oz (118 mL), NDC 15370-150-04 16 fl oz (473 mL), NDC 15370-150-16 0.7 fl oz (20mL), NDC 15370-150-99 (as physician sample) 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.
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 15370-150-16 RyClora™ (dexchlorpheniramine maleate) Oral Solution, USP 2 mg/5 mL Cherry Flavor Rx Only 16 fl. oz (473 mL) carwin PHARMACEUTICAL ASSOCIATES PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Overview
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
Indications & 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 & 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.
Warnings & Precautions
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 RYCLORA™ 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.
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)
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 Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.
Drug Interactions
Drug Interaction MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
Storage & 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.
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