Label: NICE ASSORTED 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 December 30, 2022

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  • Drug Facts

  • Active Ingredient & Purposes

    Active Ingredient (in each lozenge)

    Menthol 5 mg

    Active Ingredient (in each lozenge)Purposes
    Menthol 5 mg
    Cough Suppressant / Oral Anesthetic

  • Uses

    temporarily suppresses / relieves:

    • coughs due to minor throat and bronchial irritation from a cold or inhaled irritants
    • occasional minor sore throat pain
  • Warnings

    Warnings

    Ask a doctor before use if you have

    • chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor before use if you have

    • chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough that occurs with too much phlegm (mucus)

    When using this product

    • do not use more than directed, taking more may have a laxative effect

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
    • sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting
    • sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens

    Keep out of reach of children.

    Keep out of reach of children.

  • Directions

    • dissolve a lozenge slowly in mouth
    • may be repeated every hour for coughs as needed or as directed by a doctor
    • may be repeated every 2 hours for sore throat
    • do not take more than 10 lozenges per day

    adults and children 6 years and older5 mg
    children under 6 years ask a doctor
  • Inactive ingredients

    Acesulfame Potassium, Ascorbic Acid*, Caramel Color*, D&C Yellow No. 10*, Eucalyptus Oil, FD&C Blue No. 1*, FD&C Red No. 40*, FD&C Yellow No. 6*, Isomalt, Natural and Artificial Flavors, Sodium Citrate*, Tartaric Acid*

    *may contain one or more of these ingredients

  • Questions?

    Call 1-855-452-9500 or email at info@leosonsintl.com

  • Package Label

    NICE Assorted 24ct Cough Drops

  • INGREDIENTS AND APPEARANCE
    NICE ASSORTED COUGH DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69626-0046
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ISOMALT (UNII: S870P55O2W)  
    TARTARIC ACID (UNII: W4888I119H)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorred (Red, Clear and Yellow) Scoreno score
    ShapeROUNDSize17mm
    FlavorCHERRY (Cherry, Honey Lemon, Citrus) Imprint Code N
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69626-0046-424 in 1 BLISTER PACK; Type 0: Not a Combination Product11/08/2019
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/08/2019
    Labeler - Leosons (148605470)
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