Label: XLEAR COUGH DROPS (HONEY LEMON)- menthol lozenge

  • 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 January 10, 2023

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  • ACTIVE INGREDIENT

    4.0 mg of Menthol (per drop)

  • PURPOSE

    Cough Suppressant / Oral Anesthetic

  • INDICATIONS & USAGE

    Temporarily soothes an irritated or sore throat

  • DOSAGE & ADMINISTRATION

    Adults and children over five - Slowly dissolve one drop every two hours as needed or as directed by a physician. Children under five - Consult your physician.

  • WARNINGS

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore throat symptoms do not improve in 7 days, see your doctor promptly

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    Allergen Information: Mfg. in a facility that processes dairy, peanut, almond, walnut, nutmeg, pecan, and soy protein.

  • INACTIVE INGREDIENT

    cinnamon bark oil, clove bud oil, eucalyptus radiata leaf oil, isomalt, lemon peel oil, pectin, peppermint aerial parts oil, rosemary leaf oil, stevia leaf extract, water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    XLEAR COUGH DROPS (HONEY LEMON) 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27017-022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 mg
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    ISOMALT (UNII: S870P55O2W)  
    HONEY (UNII: Y9H1V576FH)  
    CURCUMA LONGA LEAF (UNII: H2HC4RY52C)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MALIC ACID (UNII: 817L1N4CKP)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    ColoryellowScorescore with uneven pieces
    ShapeROUNDSize22mm
    FlavorHONEY (Lemon) Imprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27017-022-0130 in 1 BOX; Type 0: Not a Combination Product12/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/12/2019
    Labeler - Xlear Inc. (839884058)
    Establishment
    NameAddressID/FEIBusiness Operations
    Primrose Candy Company005086855manufacture(27017-022)
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