MENTHOL COUGH DROPS pastille

Menthol Cough Drops by

Drug Labeling and Warnings

Menthol Cough Drops by is a Otc medication manufactured, distributed, or labeled by WHOLE FOODS MARKET, INC., Boston Nutraceutical Science SL, Boston Nutraceutical Production SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient 5.8 mg

Cough Suppressant

Oral anesthetic

PURPOSE

Uses temporarily relieves:

• cough as may occur with a cold
• ocassional minor irritation and sore throat

INDICATIONS & USAGE

Uses temporarily relieves:

cough as may occur with a cold
ocassional minor irritation and sore throat

WARNINGS

Warnings

Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days.

ASK DOCTOR

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• cough accompany by excessive phem (mucus)

STOP USE

Stop use and consult a doctor if

• cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persisten headache. These could be signs of a serious condition
• sore mouth symptons do 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 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 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
• Children under 6 years ask a doctor

OTHER SAFETY INFORMATION

• Store in a cool and dry place.
• 5 calories per drop
• May be useful for diabetics on advice of a doctor
• Excess consumation may cause laxative effect

INACTIVE INGREDIENT

isomalt, stevia extract (Stevia Rebaudiana leaf), citric acid

QUESTIONS

Questions? or to report and adverse event call: 1-844-936-8255

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOL COUGH DROPS 
menthol cough drops pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42681-0040
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ISOMALT (UNII: S870P55O2W)
STEVIA REBAUDIANA LEAF (UNII: 6TC6NN0876)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42681-0040-1	25 in 1 BAG; Type 0: Not a Combination Product	08/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/02/2024

Labeler - WHOLE FOODS MARKET, INC. (196175616)

Registrant - Boston Nutraceutical Science SL (466061824)

Establishment
Name	Address	ID/FEI	Business Operations
Boston Nutraceutical Production SL		468121064	label(42681-0040) , manufacture(42681-0040) , pack(42681-0040)