COUGH DROP- menthol lozenge NORTH COUGH DROP- menthol lozenge

North Cough Drop by

Drug Labeling and Warnings

North Cough Drop by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 original

Honeywell Cough Drop Label

INGREDIENTS AND APPEARANCE

COUGH DROP 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-1120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red (RED)	Score	no score
Shape	OVAL	Size	22mm
Flavor	CHERRY (CHERRY)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-1120-00	1 in 1 POUCH; Type 0: Not a Combination Product	09/18/2018
2	NDC: 0498-1120-05	50 in 1 BOX; Type 0: Not a Combination Product	09/18/2018
3	NDC: 0498-1120-10	100 in 1 BOX; Type 0: Not a Combination Product	09/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/18/2018

NORTH COUGH DROP 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-0119
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red (RED)	Score	no score
Shape	OVAL	Size	22mm
Flavor	CHERRY (CHERRY)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0119-00	1 in 1 POUCH; Type 0: Not a Combination Product	12/18/2017	12/31/2017
2	NDC: 0498-0119-05	50 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	12/18/2017	12/31/2017
3	NDC: 0498-0119-07	100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	08/24/2013	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/24/2013	12/31/2017

NORTH COUGH DROP 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-1119
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red (RED)	Score	no score
Shape	OVAL	Size	22mm
Flavor	CHERRY (CHERRY)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-1119-00	1 in 1 POUCH; Type 0: Not a Combination Product	01/02/2017	09/18/2018
2	NDC: 0498-1119-05	50 in 1 BOX; Type 0: Not a Combination Product	01/02/2017	09/18/2018
3	NDC: 0498-1119-10	100 in 1 BOX; Type 0: Not a Combination Product	01/02/2017	09/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/24/2013	09/18/2018

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	pack(0498-0119, 0498-1119, 0498-1120)