Label: 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 27, 2021

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  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    Menthol 5.4 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 my 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 - dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

    children under 5 years - ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    10 calories per drop

  • INACTIVE INGREDIENT

    Inactive ingredients: Corn starch, corn syrup, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin, gum arabic, medium chain triglycerides, natural flavor, potassium sorbate, soybean oil, sucrose and water.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Good Sense Menthol 30ct Cough Drops

  • INGREDIENTS AND APPEARANCE
    MENTHOL COUGH DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 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:75981-002-3030 in 1 BAG; Type 0: Not a Combination Product03/15/2013
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/15/2013
    Labeler - Geiss, Destin & Dunn (076059836)
    Registrant - Bestco Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco Inc.002149136manufacture(75981-002)
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