Label: SUGAR FREE MENTHOL COUGH 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 October 20, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    Menthol 5.8 mg

  • PURPOSE

    Purpose

    Cough suppressant / Oral anesthetic

  • INDICATIONS & USAGE

    Uses temporarily relieves:

    cough as may occur with a cold

    occasional minor irritation and 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 symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

  • ASK DOCTOR

    Ask a doctor before use if you have:

    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)
  • STOP USE

    Stop use and ask doctor if

    • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    • sore throat is severe, or irritation, pain or redness lasts or worsens
    • sore mouth does not improve in 7 days
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 5 years and over - allow 1 drop to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

    children under 5 years - ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • 6 calories per drop
    • Excess consumption may cause a laxative effect.
  • INACTIVE INGREDIENT

    Inactive ingredients: Acesulfame potassium (non-nutritive sweetener), corn starch, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin, gum arabic, hydrogenated starch hydrolysate, isomalt, medium chain triglycerides, natural and artificial flavors, potassium sorbate, soybean oil, sucralose (non-nutritive sweetener) and water.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    CareOne SF Menthol 25ct Cough Drops

  • INGREDIENTS AND APPEARANCE
    SUGAR FREE MENTHOL COUGH DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblue (light blue with blue flakes) Scoreno score
    ShapeOVALSize16mm
    FlavorMENTHOLImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-020-2525 in 1 BAG; Type 0: Not a Combination Product06/22/2016
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/22/2016
    Labeler - American Sales (809183973)
    Registrant - Bestco Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco Inc.002149136manufacture(41520-020)