NATURAL HERBAL COUGH DROPS- menthol pastille

Natural Herbal Cough Drops by

Drug Labeling and Warnings

Natural Herbal 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 4.8 mg

Cough Suppressant

Oral Anesthetic

PURPOSE

Purposes

Temporarily relieves :

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

INDICATIONS & USAGE

Purposes

Temporarily relieves :

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

WARNINGS

Warnings

Sore throat warning: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious consult a doctor promptly. If sore mouth symptons 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 ephysema.
• Cough accompanied by excessive pleghm (mucus)

STOP USE

Stop use and consult doctor if

• cough persist for more than 7 days or tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious conditions
• sore throat is severe or irritation, pain or redness lasts 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 6 years and over: allow 2 drops to dissolve slowly in mouth one at a time. Maybe repeated every two hours as needed or as directed by a doctor.
• Children under 6 years ask a doctor

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

corn syrup, sucrose, caramel color, elderflower, honehound, hyssop, lemon balm, liden fiwer, malow, peppermint, sage, thyme, wild thyme, natural flavours

QUESTIONS

Questions or to report an adverse event call:

1 617-848-4560

Monday to Friday: 9:00 am to 4:00 pm ET

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NATURAL HERBAL COUGH DROPS 
menthol pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72628-107
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.8 mg

Inactive Ingredients
Ingredient Name	Strength
HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)
CARAMEL (UNII: T9D99G2B1R)
HOREHOUND (UNII: K08036XEJV)
SUCROSE (UNII: C151H8M554)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
CORN SYRUP (UNII: 9G5L16BK6N)
LEMON BALM OIL (UNII: MJ76269K9S)
MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)
PEPPERMINT (UNII: V95R5KMY2B)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
SAGE (UNII: 065C5D077J)
THYME (UNII: CW657OBU4N)
WILD THYME (UNII: KXK6I80R8W)

Product Characteristics
Color	brown (dark)	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: 72628-107-01	50 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(72628-107) , label(72628-107)