Label: HONEY TULSI 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 26, 2018

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  • Active Ingredient

    Menthol (From Mentha spicata) (in each 3gm Drop of Serving Size)....................................................3.9 mg

  • Purposes

    Soothing sore throats

  • 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

    Basil oil, honey, eucalyptus, camphor, thymol, fast green color q.s., flavored sugar base q.s.

  • OTC Principal Display Panel

    Honey Tulsi Cough Drops
    100ct Bag

    image description

  • INGREDIENTS AND APPEARANCE
    HONEY TULSI COUGH DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57631-129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.9 mg
    Inactive Ingredients
    Ingredient NameStrength
    BASIL OIL (UNII: Z129UMU8LE)  
    HONEY (UNII: Y9H1V576FH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    THYMOL (UNII: 3J50XA376E)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeROUNDSize18mm
    FlavorHONEYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57631-129-72100 in 1 JAR; Type 0: Not a Combination Product11/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2017
    Labeler - InvaTech Pharma Solutions LLC (078602180)
    Establishment
    NameAddressID/FEIBusiness Operations
    BAPS Swaminarayan Herbal Care, A Unit of Divine Energy921183294manufacture(57631-129) , pack(57631-129)
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