MENTHOL VAPOR COUGH DROPS- menthol pastille

Menthol Vapor Cough Drops by

Drug Labeling and Warnings

Menthol Vapor Cough Drops by is a Otc medication manufactured, distributed, or labeled by BOSTON NUTRACEUTICAL PRODUCTION, S.L, Boston Nutraceutical Science SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient in each drop Purposes

Menthol 20 mg

Severe

Menthol Caugh Suppressant

Oral Anesthetic

PURPOSE

Purposes

Temporarily relieves ocassional minor irritation and pain due to:

• sore throat
• sore mouth

INDICATIONS & USAGE

Purposes

Temporarily relieves ocassional minor irritation and pain due to:

• sore throat
• sore mouth

WARNINGS

Warnings

Sore throat warning: severe or persistent throat accompanied by high fever headache, nausea and vomiting maybe serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of old.

ASK DOCTOR

Ask a doctor before use if you have

• A severe throat accompanied by difficulty in breathing or that last more than 2 days
• A severe throat accompanied by fever, headache, rash, swealling, nausea or vomiting.

STOP USE

Stop use and consult doctor if

• sore mouth symptons does not improve in 7 days or if irritation, pain or redness persists or worse

If pregnant or breast feeding, ask a health professional before use.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children.

OVERDOSAGE

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every two hours as needed or as directed by a doctor.
• Children 12 years or under do not use

OTHER SAFETY INFORMATION

Other information

• Store in a cool and dry place

INACTIVE INGREDIENT

corn syrup, sucrose, water, eucalyptus oil, acacia, FD&Blue No.1

QUESTIONS

Questions or comments call: 1-888-423-0139

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOL VAPOR COUGH DROPS 
menthol pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72628-108
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	blue (Clear with internal blue glitter)	Score	score with uneven pieces
Shape	OVAL	Size	25mm
Flavor	MENTHOL (and eucalyptus)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72628-108-01	45 in 1 BAG; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2020

Labeler - BOSTON NUTRACEUTICAL PRODUCTION, S.L (468121064)

Registrant - Boston Nutraceutical Science SL (466061824)

Establishment
Name	Address	ID/FEI	Business Operations
BOSTON NUTRACEUTICAL PRODUCTION, S.L		468121064	manufacture(72628-108) , label(72628-108)