Label: XLEAR COUGH DROPS (BLACK CHERRY)- 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

  • INACTIVE INGREDIENT

    Bett Juice, Isomalt, Malic Acid, Natural Cherry Flavor, Stevia, Titanium Dioxide, Xylitol

  • 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 2days, 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

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    XLEAR COUGH DROPS (BLACK CHERRY) 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27017-020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALIC ACID (UNII: 817L1N4CKP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BEET JUICE (UNII: IOZ32L9H3O)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    ISOMALT (UNII: S870P55O2W)  
    Product Characteristics
    ColorpinkScorescore with uneven pieces
    ShapeROUNDSize22mm
    FlavorCHERRY (Black Cherry) Imprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27017-020-0130 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(27017-020)
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