PRECAUTIONS SECTION.


PRECAUTIONS. RYCLORA(TM) 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.

STORAGE AND HANDLING SECTION.


RECOMMENDED STORAGE. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature].Dispense in tight, light-resistant container as defined in the USP, with child-resistant closure.

OVERDOSAGE SECTION.


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 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.

ADVERSE REACTIONS 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.. 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.

CLINICAL PHARMACOLOGY SECTION.


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.

CONTRAINDICATIONS SECTION.


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). Hypersensitivity to dexchlorpheniramine maleate or other antihistamines of similar chemical structure. Monoamine oxidase inhibitor therapy (See Drug Interaction section).

DESCRIPTION SECTION.


DESCRIPTION. Each mL (teaspoonful) contains:Dexchlorpheniramine Maleate, USP2 mgDexchlorpheniramine Maleate, USP, an antihistamine agent, is white, odorless crystalline powder that is freely soluble in water. The molecular formula is C16H19ClN2 C4H4O4, designated chemically as (+)-2-[p-Chloro--[2-(dimethylamino)ethyl]benzyl] pyridine maleate (1:1).M.W. 390.86Inactive 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.

DOSAGE & ADMINISTRATION SECTION.


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: mg (1 teaspoonful)Children to 11 years: mg (1/2 teaspoonful)Children to years: 0.5 mg (1/4 teaspoonful)Doses are generally given every to hours.

DRUG INTERACTIONS SECTION.


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

HOW SUPPLIED SECTION.


HOW SUPPLIED. RYCLORA(TM) Oral Solution is supplied as 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 25C (68 to 77F) [see USP Controlled Room Temperature].Dispense in tight, light-resistant container as defined in the USP, with child-resistant closure.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE. Perennial and seasonal allergic rhinitisVasomotor rhinitisAllergic conjunctivitis due to inhalant allergens and foodsMild, uncomplicated allergic skin manifestations of urticaria and angioedemaAmelioration of allergic reactions to blood or plasmaDermographismAs therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 473 mL Bottle Label. NDC 15370-150-16RyClora(TM)(dexchlorpheniramine maleate)Oral Solution, USP mg/5 mLCherry FlavorRx Only 16 fl. oz (473 mL)carwin PHARMACEUTICAL ASSOCIATES. PRINCIPAL DISPLAY PANEL 473 mL Bottle Label.

WARNINGS SECTION.


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. 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 potential for harm to the developing fetus.. Use with CNS Depressants. RYCLORA(TM) 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 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.