RYCLORA™ (dexchlorpheniramine maleate) Oral Solution, USP

Rx only

Dexchlorpheniramine Maleate, USP, an antihistamine agent, is a white, odorless crystalline powder that is freely soluble in water. The molecular formula is C₁₆H₁₉ClN₂ ∙ C₄H₄O₄, 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.

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.

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.

Antihistamines should be used with considerable caution in patients with:

1. Narrow angle glaucoma
2. Stenosing peptic ulcer
3. Pyloroduodenal obstruction
4. Symptomatic prostatic hypertrophy
5. Bladder neck obstruction

RYCLORA™ 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

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.

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.

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.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

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)

Rx Only

Manufactured for:
Carwin Pharmaceutical Associates, LLC
Hazlet, NJ 07730
www.carwinpharma.com

500403-01

REV. 03/2018

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