Label: LEMON MINT DROPS- menthol pastille

  • NDC Code(s): 82442-202-01
  • Packager: Target Corporation Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 14, 2024

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  • ACTIVE INGREDIENT

    Active ingredient Menthol 1.1 mg

    Oral anesthetic Front Panel

  • PURPOSE

    Uses temporarily relieves:

    ocasional minor irritation and pain associated with

    • sore mouth
    • sore throat
  • INDICATIONS & USAGE

    Uses temporarily relieves:

    ocasional minor irritation and pain associated with

    • sore mouth
    • sore throat

  • WARNINGS

    Warnings

    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash swelling, nausea or vomiting , consult a doctor promptly. If sore mouth symptons do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious .

  • ASK DOCTOR

    Stop and consult a doctor if

    • sore mouth does not improve in 7 days.
    • sore throat is severe, or irritation, pain or redness lasts or worsens.
  • STOP USE

    Stop and consult a doctor if

    sore mouth does not improve in 7 days.
    sore throat is severe, or irritation, pain or redness lasts or worsens.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • OVERDOSAGE

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
    • Children under 6 years: as a doctor
  • OTHER SAFETY INFORMATION

    • 5 calories per dop
    • Store in a cool and dry place
    • Phenylketonurics, contains phenylalanine
    • Excessive use may have a laxative effect.
    • Product may be useful for diabetics
  • INACTIVE INGREDIENT

    ascorbic acid (vitamin C), aspartame, citric acid, extract of lemon balm and others extract herbs (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme),isomalt, natural color (beta-carotene), natural flavors. Back Panel

  • QUESTIONS

    Questions? or to report and adverse event call: 1-800-910-68-74

  • PRINCIPAL DISPLAY PANEL

    Back

  • INGREDIENTS AND APPEARANCE
    LEMON MINT DROPS 
    menthol pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82442-202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.1 mg
    Inactive Ingredients
    Ingredient NameStrength
    FLAVONE (UNII: S2V45N7G3B)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LEMON BALM OIL (UNII: MJ76269K9S)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    HOREHOUND (UNII: K08036XEJV)  
    HYSSOPUS OFFICINALIS WHOLE (UNII: 0IQW001KPE)  
    THYME (UNII: CW657OBU4N)  
    ISOMALT (UNII: S870P55O2W)  
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SAGE (UNII: 065C5D077J)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    WILD THYME (UNII: KXK6I80R8W)  
    Product Characteristics
    ColoryellowScorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorLEMON (Mint) Imprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82442-202-0145 in 1 BAG; Type 0: Not a Combination Product05/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/15/2024
    Labeler - Target Corporation Inc. (006961700)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064manufacture(82442-202) , label(82442-202) , pack(82442-202)
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