LEADER COUGH DROPS MENTHOL FLAVOR- menthol lozenge

LEADER Cough Drops Menthol Flavor by

Drug Labeling and Warnings

LEADER Cough Drops Menthol Flavor by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Bestco, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEADER Cough Drops Menthol Flavor

Active ingredient (in each drop)

Menthol 5.4 mg

Purpose

Cough suppressant/Oral anesthetic

Uses

temporarily relieves:

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

Warnings Sore throat warning:

if sore throat is severe, persists for more than 2 days, is accompanied or followed be fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Ask a doctor before use if you have:

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

When using this product

• do not exceed recommended dosage
  

Stop use and consult doctor if

• cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
• sore throat is severe, or irritation, pain or redness lasts or worsens
• sore mouth does not improve in 7 days
  

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children5 years and over: allow 1 drop to dissolve slowly in mouth. ; May be replaced every two hours as necessary or as directed by a doctor.
• children under 5 years: ask a doctor

Other information:

• 10 calories per drop
  

Inactive ingredients:

Blue flakes (FDandC blue no. 1, glycerin, gum arabic, potassium sorbate), eucalyptus oil, FDandC blue no. 1, FDandC red no. 40, glucose syrup, natural flavoring, sucrose and water. Soybean oil and corn starch used as processing aids.

Questions?

Or to report an adverse event call 1-800-200-6313. Monday - Friday, 9AM to 4PM EST

DISTRIBUTED BY

CARDINAL HEALTH DUBLIN, OHIO 43017 CIN 4831053 www.myleader.com 1-800-200-6313

UD Certified GF Gluten-Free

* This product is not manufactured or distributed by Kraft, owner of the registered trademark HallsR, or by any of its affiliates.

LEADER Cough Drops Menthol Flavor 30 Count (

49781-012-30)

INGREDIENTS AND APPEARANCE

LEADER COUGH DROPS MENTHOL FLAVOR 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.4 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
ACACIA (UNII: 5C5403N26O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CORN SYRUP (UNII: 9G5L16BK6N)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
SOYBEAN OIL (UNII: 241ATL177A)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL (Oval)	Size	12mm
Flavor		Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49781-012-30	30 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/25/2013

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco, Inc.		002149136	manufacture(49781-012)