Label: COUGH DROP- menthol lozenge
NORTH COUGH DROP- menthol lozenge

  • NDC Code(s): 0498-0119-00, 0498-0119-05, 0498-0119-07, 0498-1119-00, view more
    0498-1119-05, 0498-1119-10, 0498-1120-00, 0498-1120-05, 0498-1120-10
  • Packager: Honeywell Safety Products USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 19, 2024

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  • Active ingredient (in each drop)

    Menthol 7 mg

  • Purpose

    Cough suppressant /oral anesthetic

  • Uses

    temporarily relieves

    • cough as may occur with a cold or inhaled irritants
    • occasional minor irritation, pain, sore mouth and sore throat
  • Warnings

    Sore throat warning: if sore throat is severe, lasts for more than 2 days, is accompanied or followed by a fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly

    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

    • a persistant cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompaniedby fever, rash, or persistant headache.
    • irritation, pain, or redness persist or worsen

    If pregnant or breast feeding:

    • ask a health professional before use

    Keep this and all drugs out of the reach of children

    Enter section text here

  • Directions

    • adults and children 2 years of age and over
    • dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed
    • children under 2 years of age: ask a doctor
  • Other information

    • gluten free
    • 15 calories per cough drop
    • store at room temperature
    • protect from moisture
    • soybean oil used as a processing aid
    • do not use if wrapper is open
  • Inactive ingredients

    eucalyptus oil, FD &C red #40, flavoring, glucose syrup, sucrose, water

  • Questions or comments?

    call 800-430-5490

  • Principal Display Panel

    Cough drops

  • Cough drops original

    cough drop original

  • Honeywell Cough Drop Label

    Honeywellcoughdrops

  • INGREDIENTS AND APPEARANCE
    COUGH DROP 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-1120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (RED) Scoreno score
    ShapeOVALSize22mm
    FlavorCHERRY (CHERRY) Imprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-1120-001 in 1 POUCH; Type 0: Not a Combination Product09/18/2018
    2NDC:0498-1120-0550 in 1 BOX; Type 0: Not a Combination Product09/18/2018
    3NDC:0498-1120-10100 in 1 BOX; Type 0: Not a Combination Product09/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/18/2018
    NORTH COUGH DROP 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0119
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (RED) Scoreno score
    ShapeOVALSize22mm
    FlavorCHERRY (CHERRY) Imprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0119-001 in 1 POUCH; Type 0: Not a Combination Product12/18/201712/31/2017
    2NDC:0498-0119-0550 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product12/18/201712/31/2017
    3NDC:0498-0119-07100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product08/24/201312/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/201312/31/2017
    NORTH COUGH DROP 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-1119
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (RED) Scoreno score
    ShapeOVALSize22mm
    FlavorCHERRY (CHERRY) Imprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-1119-001 in 1 POUCH; Type 0: Not a Combination Product01/02/201709/18/2018
    2NDC:0498-1119-0550 in 1 BOX; Type 0: Not a Combination Product01/02/201709/18/2018
    3NDC:0498-1119-10100 in 1 BOX; Type 0: Not a Combination Product01/02/201709/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/201309/18/2018
    Labeler - Honeywell Safety Products USA, Inc (118768815)
    Registrant - Honeywell Safety Products USA, Inc (118768815)
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