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 SL, Boston Nutraceutical Science SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient in each drop Purposes

Menthol 5.8 mg

Cough Suppressant

Oral anesthetic

PURPOSE

Purposes

Cough suppressant/

Oral anesthetic

INDICATIONS & USAGE

Uses Temporarily relieves:

• cough as may occur with cold or inhaled irritants
• ocassional minor irritations and sore throat

WARNINGS

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious.

ASK DOCTOR

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

cough accompanied by excessvie phlegm (mucus)

STOP USE

Stop use and consult doctor if

• cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
• sore throat is severe, or irritation, pain or redness last or worsens
• sore mouth does not improve in 7 days

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 5 years and over: allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.
• Children under 5 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

• 6 calories per drop
• May be useful for diabetics on the advise of a doctor
• Excessive consumption may cause laxative effect

INACTIVE INGREDIENT

Isomalt, stevia, water

QUESTIONS

Questions or comments call: 617-848-4560

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOL COUGH DROPS 
menthol pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72628-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.8 mg

Inactive Ingredients
Ingredient Name	Strength
ISOMALT (UNII: S870P55O2W)
WATER (UNII: 059QF0KO0R)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)

Product Characteristics
Color	blue (Light blue)	Score	score with uneven pieces
Shape	OVAL	Size	17mm
Flavor	MENTHOL	Imprint Code	None
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72628-105-01	36 in 1 BAG; Type 0: Not a Combination Product	03/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/26/2019

Labeler - Boston Nutraceutical Production SL (468121064)

Registrant - Boston Nutraceutical Science SL (466061824)

Establishment
Name	Address	ID/FEI	Business Operations
Boston Nutraceutical Production SL		468121064	manufacture(72628-105) , label(72628-105) , pack(72628-105)