DEXCHLORPHENIRAMINE: 1,596 Adverse Event Reports & Safety Profile

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

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.

Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor Children under 6 years of age: Consult a doctor.

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.

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not exceed recommended dosage marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery excitability may occur especially in children Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. symptoms do not improve within 7 days or are accompanied by fever nervousness, dizziness, or sleeplessness occur If pregnant or breastfeeding ask a health professional before use Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.

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

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

Active ingredients (in each 5 mL teaspoonful)

Purpose Dexchlorpheniramine Maleate

1 mg Antihistamine Dextromethorphan HBr 10 mg Cough Suppressant Phenylephrine HCl 5 mg Nasal Decongestant

Inactive ingredients Citric acid anhydrous, cotton candy flavoring, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.