Label: CLORRELIEF KIDS- chlorpheniramine maleate aerosol, spray

  • NDC Code(s): 82643-011-15
  • Packager: FERRER MEDICAL INNOVATIONS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 24, 2023

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  • Active ingredient

    Chlorpheniramine Maleate 0.5%

    Purpose

    Antihistamine

  • Uses

    Temporarily relieves symptoms of hay fever or other upper respiratory allergies:

    • runny nose
    • itchy nose or throat
    • sneezing itchy, watery eyes
  • Warnings

    Ask a doctor before use if you have

    glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if

    you are taking sedatives or tranquilizers

    When using this product

    • you may get drowsy
    • avoid alcoholic drinks, sedatives & tranquilizers, may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    If pregnant or breastfeeding,

    ask your doctor before use.

    Keep out of reach of children

    Do not use to make a child sleepy. In case of overdose, getmedical help or contact a Poison Control Center right away.

  • Inactive ingredients

    Aloe Vera, glycerin, grapefruit seed extract, hyaluronic acid, peppermint flavor, purified water, stevia, xylitol.

  • Directions

    Adults and children 12 years and over:

    For each application, spray 4 times every 4 to 6 hours,

    do not exceed 6 applications in 24 hours.

    Children 6 to under 12 years of age:
    Should be supervised in the use of this product. For each application, spray 2 times every 4 to 6 hours. Do not exceed 3 applications in 24 hours.

    Children 4 to under 6 years of age:
    Do not use unless directed by a doctor.

    Children under 4 years of age:
    Do not use.

  • Other Information

    Store at room temperature 15-30° C (59-86° F)

  • ClorRelief Box

    ClorRelief Kids Carton Outline

  • INGREDIENTS AND APPEARANCE
    CLORRELIEF KIDS 
    chlorpheniramine maleate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82643-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82643-011-151 in 1 CARTON04/24/2023
    115 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/21/2023
    Labeler - FERRER MEDICAL INNOVATIONS LLC (041608434)
    Registrant - FERRER MEDICAL INNOVATIONS LLC (041608434)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xlear Inc.839884058manufacture(82643-011)
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