Label: CVS MENTHOL MEDICATED THROAT DROPS- 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 April 11, 2019

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  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    Menthol 20 mg

  • PURPOSE

    Purpose

    Oral anesthetic

  • INDICATIONS & USAGE

    Uses temporarily relieves:

    • occasional minor irritation and pain associated with sore throat and sore mouth
  • 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. Do not use more than 2 days or administer to children under 12 years of age.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days.
    • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting.
  • STOP USE

    Stop use and consult doctor if

    • sore mouth does not improve in 7 days
    • irritation, pain 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 out of reach of children.

  • WHEN USING

    Do not exceed recommended dosage.

  • DOSAGE & ADMINISTRATION

    DIrections

    adults and children 12 years and over - dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

    children 12 years and under - do not use

  • OTHER SAFETY INFORMATION

    Other information

    • 10 calories per drop
    • do not use if bag is torn or open
  • INACTIVE INGREDIENT

    Inactive ingredients: Corn starch, corn syrup, eucalyptus oil, FD&C blue no. 1, glycerin, gum arabic, medium chain triglycerides, potassium sorbate, soybean oil, sucrose and water.

  • QUESTIONS

    Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

  • PRINCIPAL DISPLAY PANEL

    CVS Menthol Medicated Drop 45ct

  • INGREDIENTS AND APPEARANCE
    CVS MENTHOL MEDICATED THROAT DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-356
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (Clear with Blue Flakes) Scoreno score
    ShapeOVALSize17mm
    FlavorMENTHOLImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-356-4545 in 1 BAG; Type 0: Not a Combination Product04/11/2019
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/11/2019
    Labeler - CVS Pharmacy (062312574)
    Registrant - Bestco Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco Inc.002149136manufacture(69842-356)
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