LEADER SUGAR FREE COUGH DROPS BLACK CHERRY- menthol lozenge

LEADER Sugar Free Cough Drops Black Cherry by

Drug Labeling and Warnings

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

Drug Details [pdf]

LEADER Sugar Free Cough Drops Black Cherry

Active ingredient (in each drop)

Menthol 5.8 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:

acesulfame potassium, blue no. 1, eucalyptus oil, flavoring, hydrogenated starch hydrolysate, isomalt, red no. 40, sucralose and water. Soybean oil used as a processing aid.

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 4562393 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 Sugar Free Cough Drops Black Cherry 25 Count (

49781-043-25)

INGREDIENTS AND APPEARANCE

LEADER SUGAR FREE COUGH DROPS BLACK CHERRY 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-043
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ISOMALT (UNII: S870P55O2W)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
SOYBEAN OIL (UNII: 241ATL177A)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	12mm
Flavor	CHERRY (Black Cherry)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49781-043-25	25 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(49781-043)