Label: HERBOMINT 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 May 22, 2019

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  • Active Ingredient

    Menthol (From Mentha spicata) (in each 3gm Drop of Serving Size)....................................................9.99 mg

  • Uses

    Natural way of calming cough and soothing sore throats

  • Warnings

    Sore throat warnings: 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. These may be serious.
    Do not use for children under 6 years of age unless directed by a doctor.

  • 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 accompanied 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 persist or worsens
  • Keep out of reach of children

  • Directions

    • adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as if needed or as directed by a doctor
    • children under 6 years: ask a doctor
    • do not bite or chew
  • Other information

    Protect from heat and moisture

  • Inactive Ingredients

    Holy Basil, Liquorice, Acacia catechu, Malabar, Cardamom, Clove, eucalyptus oil, caramel color q.s sugar base q.s

  • PURPOSE

    Natural way of calming cough and soothing sore throats

  • OTC Principal Display Panel

    Herbomint Cough Drops

    100ct

    100

  • INGREDIENTS AND APPEARANCE
    HERBOMINT COUGH DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57631-205
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9.99 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARDAMOM (UNII: 8BC4CUT4JL)  
    CARAMEL (UNII: T9D99G2B1R)  
    BASIL (UNII: 2U0KZP0FDW)  
    LICORICE (UNII: 61ZBX54883)  
    ACACIA CATECHU WHOLE (UNII: TJ6XA84OQF)  
    MALABAR PLUM JUICE (UNII: 58D570WY62)  
    CLOVE (UNII: K48IKT5321)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize18mm
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57631-205-29100 in 1 PACKAGE; Type 0: Not a Combination Product05/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/22/2019
    Labeler - InvaTech Pharma Solutions LLC (078602180)
    Establishment
    NameAddressID/FEIBusiness Operations
    BAPS Swaminarayan Herbal Care, A Unit of Divine Energy921183294manufacture(57631-205) , pack(57631-205)
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