NICE MENTHOL COUGH DROPS- menthol lozenge

NICE Menthol Cough Drops by

Drug Labeling and Warnings

NICE Menthol Cough Drops by is a Otc medication manufactured, distributed, or labeled by Leosons International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each lozenge)

Menthol 5 mg

PURPOSE

Purpose

Cough Suppressant / Oral Anesthetic

INDICATIONS & USAGE

Uses temporarily suppresses / relieves:

• coughs due to minor throat and bronchial irritation from a cold or inhaled irritants
• occasional minor sore throat pain

WARNINGS

Warnings

Ask a doctor before use is you have

• chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much phlegm (mucus)

WHEN USING

When using this product

• do not use more than directed, taking more may have a laxative effect

STOP USE

Stop use and ask doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
• sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting
• sore mouth symptoms lasts more than 7 days, or irritation, pain or redness continues or worsens

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• dissolve a lozenge slowly in mouth
• may be repeated every hour for coughs as needed or as directed by a doctor
• may be repeated every 2 hours for sore throat
• do not take more than 10 lozenges per day

adults and children 6 years and older - 5 mg

children under 6 years - ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Acesulfame Potassium, Citric Acid, Eucalyptus Oil, Isomalt, Other Natural and Artificial Flavors

QUESTIONS

Questions? Call 1-855-452-9500 or email at info@leosonsintl.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NICE MENTHOL COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69626-0043
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	17mm
Flavor	MENTHOL	Imprint Code	N
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69626-0043-4	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/08/2019

Labeler - Leosons (148605470)

Registrant - Bestco LLC (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco LLC		002149136	manufacture(69626-0043)