COUGH DROPS- menthol pastille

Cough Drops by

Drug Labeling and Warnings

Cough Drops by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, 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 or administer to children under 12 years of age.

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 sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting

STOP USE

Stop use and consult a doctor if

• sore mouth symptons do not improve in 7 days or if irritation, pains 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 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
• Children under 12 years and under do not use

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

citric acid, black currant, black carrot, flavors, glucose syrup, sucrose

QUESTIONS

Questions? or to report and adverse event call: 1-800-423-0139

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUGH DROPS 
menthol pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-016
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
CORN SYRUP (UNII: 9G5L16BK6N)
SUCROSE (UNII: C151H8M554)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BLACK CURRANT (UNII: 9755T40D11)
BLACK CARROT (UNII: 27793ZFD2L)

Product Characteristics
Color	red	Score	score with uneven pieces
Shape	OVAL	Size	25mm
Flavor	CHERRY	Imprint Code	None
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-016-01	80 in 1 BAG; Type 0: Not a Combination Product	12/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/14/2022

Labeler - Topco Associates LLC (006935977)

Registrant - Boston Nutraceutical Science SL (466061824)

Establishment
Name	Address	ID/FEI	Business Operations
Boston Nutraceutical Production SL		468121064	label(76162-016) , pack(76162-016) , manufacture(76162-016)