COUGH DROP- menthol lozenge 
NORTH COUGH DROP- menthol lozenge 
Honeywell Safety Products USA, Inc

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.

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0498-1120, 0498-0119 & 0498-1119: Cough Drops

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

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 other09/18/201812/31/2024
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)

Revised: 1/2024
Document Id: 0eca82c1-7a3b-e8df-e063-6394a90aa100
Set id: 87fd9e18-8681-47a4-8614-239b8b55d69f
Version: 15
Effective Time: 20240112
 
Honeywell Safety Products USA, Inc