Label: LEGEND COUGH LOZENGE- 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 April 15, 2020

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  • Active Ingredient

    Menthol

  • Purpose

    Cough Suppressant/ Oral Anesthetic

  • Uses

    Temporarily suppresses/relieves:

    • Coughs due to minor throat and bronchial irritation from a cold or inhaled irritant
    • Occasional minor sore throat pain
  • 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)

    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
  • 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.
  • Keep out of reach of children

    • Adults and children 6 years and older 10 mg
    • Children under 6 years ask a doctor
  • Inactive Ingredients

    Honey powder, Ginger extract, Licorice extract, Eucalyptol oil, Mexican Mint oil, Cinnamon oil, Mannitol, Sorbitol, Povidone K30, Xylitol, Silicone Dioxide, Magnesium stearate, Aspartame, Sucralose, Sodium benzoate, FD&C Yellow No. 5, FD&C Blue No. 1

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    LEGEND COUGH LOZENGE 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-842
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HONEY (UNII: Y9H1V576FH)  
    GINGER (UNII: C5529G5JPQ)  
    LICORICE (UNII: 61ZBX54883)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    PLECTRANTHUS AMBOINICUS WHOLE (UNII: T444G60821)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    MANNITOL (UNII: 3OWL53L36A)  
    Sorbitol (UNII: 506T60A25R)  
    Povidone K30 (UNII: U725QWY32X)  
    Xylitol (UNII: VCQ006KQ1E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Magnesium stearate (UNII: 70097M6I30)  
    Aspartame (UNII: Z0H242BBR1)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Sodium benzoate (UNII: OJ245FE5EU)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorgreen (GREEN) Scoreno score
    ShapeROUNDSize15mm
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13411-842-2424 in 1 BOX; Type 0: Not a Combination Product04/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/15/2020
    Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)