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

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.

----------

Cough Drops

Active ingredient (in each drop)

Menthol 7 mg

Purpose

Cough suppressant /oral anesthetic

Uses

temporarily relieves

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

Other information

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
OTC monograph finalpart34109/18/2018
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
OTC monograph finalpart34108/24/201312/31/2017
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
OTC monograph finalpart34108/24/201309/18/2018
Labeler - Honeywell Safety Products USA, Inc (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc079287321pack(0498-0119, 0498-1119, 0498-1120)

Revised: 1/2020
Document Id: 9c87d588-75b6-152b-e053-2995a90a32fc
Set id: 87fd9e18-8681-47a4-8614-239b8b55d69f
Version: 11
Effective Time: 20200119
 
Honeywell Safety Products USA, Inc