Label: COUGH DROPS DOLLAR GENERAL MENTHOL 80CT- menthol lozenge

  • NDC Code(s): 75712-021-01
  • Packager: Dollar General Corporation
  • 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 June 27, 2023

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  • Drug Facts

  • 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 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 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 and ask a 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 out of reach of children.

  • 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 information

    • 11 calories per drop
    • do not use if bags is torn or open
    • Contains: Soy
  • Inactive ingredients

    Corn Syrup, eucalyptus oil, FD&C blue no. 1, FD&C red no.40, gum Arabic, maltodextrin, natural flavor, soy lecithin, sucrose and water

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    COUGH DROPS DOLLAR GENERAL MENTHOL 80CT 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75712-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75712-021-016 in 1 CARTON07/21/2023
    180 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/21/2023
    Labeler - Dollar General Corporation (006946172)
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