Label: COUGH DROPS- menthol tablet, orally disintegrating

  • NDC Code(s): 80404-501-01, 80404-501-02, 80404-501-03, 80404-501-04
  • Packager: Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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

  • SPL UNCLASSIFIED SECTION

    Cough Drops

  • ACTIVE INGREDIENT

    Menthol

  • PURPOSE

    cough suppressant, oral anesthetic

  • INDICATIONS & USAGE

    temporarily relieves: cough due to cold, occasional minor irritation or sore throat

  • WARNINGS

    Sore throat warning: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorprompfly. These may be serious.

  • DO NOT USE

    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 1 week, tends to recur,
    or is accompained by fever, rash, or persistent headache. These could be signs of a
    serious condition. sore mouth does not improve in 7 days

    irritation, pain, or redness persists or worsens.

  • WHEN USING

    adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.

    children under 5 years: ask a doctor.

  • STOP USE

    Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,
    or is accompained by fever, rash, or persistent headache. These could be signs of a
    serious condition. sore mouth does not improve in 7 days irritation, pain, or redness
    persists or worsens.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.

    children under 5 years: ask a doctor.

  • STORAGE AND HANDLING

    Dry, avoid sunlight

  • INACTIVE INGREDIENT

    EUCALYPTUS OIL
    FD&C BLUE NO. 1
    FD&C RED NO. 40
    POTASSIUM CITRATE
    SOY LECITHIN
    SUCRALOSE
    SUCROSE
    GLUCOSE SYRUP
    CITRIC ACID
    Water

  • PRINCIPAL DISPLAY PANEL

    label0

  • INGREDIENTS AND APPEARANCE
    COUGH DROPS 
    menthol tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80404-501
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorblueScorescore with uneven pieces
    ShapeOVALSize20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80404-501-0125 in 1 BAG; Type 0: Not a Combination Product06/29/2023
    2NDC:80404-501-0230 in 1 BAG; Type 0: Not a Combination Product06/29/2023
    3NDC:80404-501-0370 in 1 BAG; Type 0: Not a Combination Product06/29/2023
    4NDC:80404-501-0480 in 1 BAG; Type 0: Not a Combination Product06/29/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/29/2023
    Labeler - Xinsanyang Pharmaceutical (Xiamen) Co., Ltd. (546457554)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.546457554manufacture(80404-501)