Label: RYCLORA- dexchlorpheniramine maleate liquid

  • NDC Code(s): 15370-150-04, 15370-150-16, 15370-150-99
  • Packager: CARWIN PHARMACEUTICAL ASSOCIATES, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 2, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx only

  • DESCRIPTION

    Each 5 mL (teaspoonful) contains:
    Dexchlorpheniramine Maleate, USP2 mg

    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).

    Chemical Structure

    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.

  • 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.

  • 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.

  • 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

    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.

  • 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.

  • ADVERSE REACTIONS

    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.

  • 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.

  • 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.

  • 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.

  • SPL UNCLASSIFIED SECTION

    Rx Only

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

    500403-01

    REV. 03/2018

  • 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
  • INGREDIENTS AND APPEARANCE
    RYCLORA 
    dexchlorpheniramine maleate liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:15370-150
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dexchlorpheniramine Maleate (UNII: B10YD955QW) (Dexchlorpheniramine - UNII:3Q9Q0B929N) Dexchlorpheniramine Maleate2 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    menthol, unspecified form (UNII: L7T10EIP3A)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15370-150-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/07/2018
    2NDC:15370-150-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/07/2018
    3NDC:15370-150-9920 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20252010/07/2018
    Labeler - CARWIN PHARMACEUTICAL ASSOCIATES, LLC (079217215)