COUGH DROPS- menthol pastille

Cough Drops by

Drug Labeling and Warnings

Cough Drops by is a Otc medication manufactured, distributed, or labeled by United Natural Foods, Inc., Boston Nutraceutical Science SL, Boston Nutraceutical Production SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

• Menthol 5.8 mg cough suppresant 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
• 5 calories per drop
• Maybe useful for diabetics on the advice of a doctor
• Excess comsuption may cause laxative effect

INACTIVE INGREDIENT

citric acid, isomalt, stevia

QUESTIONS

Questions or comments: 1-855-423-2630

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUGH DROPS 
menthol pastille

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83455-201
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
STEVIA LEAF (UNII: 6TC6NN0876)
ISOMALT (UNII: S870P55O2W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	yellow (Transparent)	Score	score with uneven pieces
Shape	OVAL	Size	25mm
Flavor	HONEY (Lemon)	Imprint Code	None
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83455-201-01	200 in 1 BAG; Type 0: Not a Combination Product	05/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/12/2023

Labeler - United Natural Foods, Inc. (943556183)

Registrant - Boston Nutraceutical Science SL (466061824)

Establishment
Name	Address	ID/FEI	Business Operations
Boston Nutraceutical Production SL		468121064	manufacture(83455-201) , label(83455-201) , pack(83455-201)