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Kidkare (Rugby Laboratories, Inc.)

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LIQUID 118 mL in 1 BOTTLE (0536-2310-97) Label Information

Complete Kidkare Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each 2 TSP (10 mL)) Purposes
    Chlorpheniramine maleate, USP 2 mg Antihistamine
    Dextromethorphan HBr, USP 10 mg Cough suppressant
    Pseudoephedrine HCl, USP 30 mg Nasal decongestant

  • Uses

    temporarily relieves these symptoms of the common cold, hay fever or other upper respiratory allergies:

    • cough
    • runny nose
    • nasal congestion
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes

  • Warnings

    Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if child has

    • diabetes
    • glaucoma
    • thyroid disease
    • heart disease
    • high blood pressure
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem such as chronic bronchitis
    • chronic cough that lasts such as occurs with asthma

    Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

    When using this product
    • do not use more than directed
    • excitability may occur, especially in children
    • drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness

    Stop use and ask a doctor if
    • the child gets nervous, dizzy or sleepless
    • cough lasts more than 7 days, comes back or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
    • symptoms do not get better within 7 days or occur with fever

    Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.


  • Directions

    • dose may be repeated every 6 hours.
    • do not exceed 4 doses in a 24-hour period
    • use enclosed dosage cup only. Do not use any other device.
    AGE DOSE
    Children 6 to 11 years 2 TSP
    Children under 6 years Do not use

  • Other information

    store at 20°-25° C (68°-77° F)


  • Inactive ingredients

    artificial cherry flavor, citric acid, FD&C red #40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution


  • Questions or comments?

    1-800-645-2158


  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Rugby Laboratories
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152


  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Rugby®

    NDC 0536-2310-97

    Cherry Flavored
    Alcohol Free

    Kid
    Kare

    Antihistamine
    Cough Suppressant
    Nasal Decongestant

    Children's
    Cough/Cold
    Liquid

    4 fl oz (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    KIDKARE   COUGH/COLD
    chlorpheniramine, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-2310
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate 1 mg  in 5 mL
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 5 mg  in 5 mL
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 15 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Anhydrous Trisodium Citrate (UNII: RS7A450LGA)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    FD&C Red no. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Water (UNII: 059QF0KO0R)  
    Cherry (UNII: BUC5I9595W)  
    Product Characteristics
    Color RED (Reddish) Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-2310-97 1 in 1 CARTON 01/13/2011
    1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 01/13/2011
    Labeler - Rugby Laboratories, Inc. (079246066)