Label: MEIJER MENTHOL COUGH DROPS- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL

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 6, 2014

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  • Meijer Menthol Cough Drops


  • Active ingredient (in each drop)

    Menthol 5.4 mg

    Purpose

    Cough suppressant/Oral anesthetic

  • Uses

    temporarily relieves:

    • cough as may occur with a cold
    • occasional minor irritation and sore throat
  • Warnings Sore throat warning:

    if sore throat is severe, persists for more than 2 days, is accompanied or followed be 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 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)

    When using this product

    • do not exceed recommended dosage

    Stop use and consult 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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep this and all drugs out of the reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children
    5 years and over
    		allow 1 drop to dissolve slowly in mouth.
    May be replaced every two hours as necessary or as directed by a doctor.
    children under 5 years
    		ask a doctor
  • Other information:

    • 10 calories per drop
  • Inactive ingredients:

    Blue fakes (FD&C blue no.1, glycerin, gum arabic, potassium sorbate), eucalyptus oil, FD&C

    blue no. 1, FD&C red no. 40, glucose syrup, natural favoring, sucrose and water. Soybean oil and corn starch used as

    processing aids.

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    MADE IN THE U.S.A.

    DIST. BY: MEIJER DISTRIBUTION, INC.

    2929 WALKER AVE., NW

    GRAND RAPPIDS, MI 49544

    www.meijer.com

    UD GF Gluten-Free

    *This product is not manufactured or distributed by Mondelez Global LLC, owner of the registered trademark Halls®, or by any of its afliates.

  • Meijer Menthol Cough Drops 200 Count (41250-078-00)

    FrontMenthol

    BackMenthol

  • INGREDIENTS AND APPEARANCE
    MEIJER MENTHOL COUGH DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-078
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACACIA (UNII: 5C5403N26O)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVAL (Oval) Size22mm
    FlavorImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-078-00200 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/06/2014
    Labeler - Meijer Distribution, Inc (006959555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco, Inc.002149136manufacture(41250-078)
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