Label: LEMON MINT HERB THROAT DROPS- sugar free lemon mint herb pastille

  • 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 May 29, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient:

    • Menthol 1.1 mg.............oral anesthetic
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  • PURPOSE

    Uses temporarily relieves:

    ocassional minor irritation and pain associated with:

    • sore mouth
    • sore throat
  • INDICATIONS & USAGE

    Uses temporarily relieves:

    ocassional minor irritation and pain associated with:

    • sore mouth
    • sore throat

  • WARNINGS

    Warnings

    Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. If sore mouth symptons does not improve in 7 days see your dentist or doctor promptly. These symptoms maybe serious.

  • ASK DOCTOR

    Stop and consult a doctor if

    • sore throat is severe, or irritation, pain or redness last or worseness
    • sore mouh does not improve in 7 days
  • STOP USE

    Stop use and consult a doctor if

    • sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists 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 2 drop slowly in mouth one at a time. Maybe repeated every 2 hours as needed or as directed by a doctor.
    • Children under 6 years as a Doctor
  • OTHER SAFETY INFORMATION

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

    ascorbic acid (Vitamin C), aspartame, citric acid, extract of lemon balm, and other extracts herbs (elderflower, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme. wild thyme) isomalt, natural color (beta carotene), natural flavors

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  • QUESTIONS

    Questions? or to report and adverse event call: 1-833-552-1767

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    LEMON MINT HERB THROAT DROPS 
    sugar free lemon mint herb pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-852
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.1 mg
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT (UNII: V95R5KMY2B)  
    HOREHOUND (UNII: K08036XEJV)  
    MELISSA OFFICINALIS FLOWER (UNII: RCU5REA2I1)  
    THYME (UNII: CW657OBU4N)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    SAGE (UNII: 065C5D077J)  
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    WILD THYME (UNII: KXK6I80R8W)  
    ISOMALT (UNII: S870P55O2W)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    Product Characteristics
    ColoryellowScorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorCITRUS (Herbs) Imprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-852-0160 in 1 BAG; Type 0: Not a Combination Product05/29/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/29/2023
    Labeler - CVS Pharmacy (062312574)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064label(51316-852) , pack(51316-852) , manufacture(51316-852)
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