Label: BRONCOLIN HONEY EUCALYPTUS- menthol lozenge

  • NDC Code(s): 62583-002-22
  • Packager: BRONCOLIN, S.A. de C.V.
  • 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 October 14, 2022

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  • Active Ingredient

    Menthol 7.5mg

  • Purpose

    Cough Suppressant/Oral Anesthetic

  • Uses

    temporarily relieves •Cough due to minor and bronchial irritation occurring with a cold or inhaled irritants •occasional minor irritation and sore throat

  • Warnings

    Sore throat warning: 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 symptoms may be serious.

  • 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)

  • When using this product

    •do not exceed recommended dosage

  • Stop use and ask a doctor if

    •cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. •sore throat is severe or irritation, pain, or redness lasts or worsens •sore mouth does not improve in 7 days.

  • Keep out of reach of children

    if pregnant or breast feeding ask a Health Professional before using

  • Directions

    • adults and children 6 years and older: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor • children under 6 years: ask a doctor.

  • Inactive Ingredients

    Citric Acid, Elderberry flower extract, Eucalyptus leaf extract, Eucalyptus oil leaf extract, Glucose, Honey, Mullein flower extract, Sugar

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    BRONCOLIN  HONEY EUCALYPTUS
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62583-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    EUCALYPTUS PIPERITA LEAF (UNII: 4GG3SCZ7GT)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    HONEY (UNII: Y9H1V576FH)  
    VERBASCUM DENSIFLORUM FLOWER (UNII: N7FC535Q3R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Coloryellow (Amber) Scoreno score
    ShapeROUND (Lozenge) Size17mm
    FlavorHONEY (Honey and Eucalyptus) Imprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62583-002-2222 in 1 BAG; Type 0: Not a Combination Product04/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01204/01/2015
    Labeler - BRONCOLIN, S.A. de C.V. (812946390)
    Establishment
    NameAddressID/FEIBusiness Operations
    BRONCOLIN, S.A. de C.V.812946390manufacture(62583-002)
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