Label: SUGAR FREE LEMON MINT HERB THROAT DROPS- menthol lozenge

  • NDC Code(s): 63667-956-19, 63667-956-24, 63667-956-45, 63667-956-90, view more
    63667-956-95
  • Packager: Ricola USA Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 18, 2023

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  • Drug Facts

    Purpose

    Oral anesthetic

  • Active Ingredient (in each drop)

    Menthol, 1.1 mg

  • Uses

    temporarily relieves occasional minor irritation and pain associated with:

    • sore mouth
    • sore throat
  • Warnings

    Do not use

    • in children under 6 years of age unless directed by a doctor.
  • Stop use and ask a doctor if

    • sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting.
    • sore mouth symptoms do not improve in 7 days.
  • Keep out of reach of children.


  • Directions

    • adults and children 6 years and older:  dissolve 3 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
    • children under 6 years: ask a doctor
  • Other Information

    • Phenylketonurics: contains phenylalanine 1 mg per drop
    • excessive use may have a laxative effect
    • store in a dry place
    • product may be useful for diabetics on the advice of a doctor

    Exchange information:   2 Drops = FREE Exchange

                                                    7 Drops = 1 Fruit

    Dietary exchanges based on Exchange Lists for Diabetics

    © 2008 American Diabetes Association, American Dietetic Association

  • Inactive Ingredients

    ascorbic acid (vitamin C), aspartame, citric acid, extracts of lemon balm and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural color (beta-carotene), natural flavors
  • PRINCIPAL DISPLAY PANEL

    Image of SF Lemon Mint.jpg

  • INGREDIENTS AND APPEARANCE
    SUGAR FREE LEMON MINT HERB THROAT DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63667-956
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.1 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ISOMALT (UNII: S870P55O2W)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize24mm
    FlavorLEMON (LEMON MINT) Imprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63667-956-1919 in 1 BAG; Type 0: Not a Combination Product01/01/1942
    2NDC:63667-956-95105 in 1 BAG; Type 0: Not a Combination Product01/01/1942
    3NDC:63667-956-90210 in 1 BAG; Type 0: Not a Combination Product01/01/1942
    4NDC:63667-956-2424 in 1 BAG; Type 0: Not a Combination Product01/01/1942
    5NDC:63667-956-4545 in 1 BAG; Type 0: Not a Combination Product01/01/1942
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/01/1942
    Labeler - Ricola USA Inc. (177265261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag480227248manufacture(63667-956)
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