MENTHOL COUGH DROPS- menthol pastille

Menthol Cough Drops by

Drug Labeling and Warnings

Menthol 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 5.4 mg

Cough 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 persistant sore 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 old.

ASK DOCTOR

Ask a doctor before use if you have:

• a severe throat accompanied by difficulty in breathing or that lasts more than 2 days
• a sore throat accompanied by fever, headache, rash, swelling, nausea and 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 worsens

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep 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. Repeat every two hours as needed or as directed by a doctor.
• Children under 12 years do not use

OTHER SAFETY INFORMATION

Other information

• Store in a cool and dry place
• 11 calories per drop

INACTIVE INGREDIENT

glucose, syrup, sucrose

QUESTIONS

Questions or to report an adverse event call:

1 833 5521737

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOL COUGH DROPS 
menthol pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72628-118
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.4 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white (transparent)	Score	score with uneven pieces
Shape	OVAL	Size	25mm
Flavor	MENTHOL (and herbal)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72628-118-01	30 in 1 BAG; Type 0: Not a Combination Product	09/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/02/2022

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(72628-118) , label(72628-118)