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LEADER Cough Drops Menthol Flavor

Dosage form: lozenge
Ingredients: MENTHOL 5.4mg
Labeler: Cardinal Health
NDC Code: 49781-012

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

LEADER Cough Drops Menthol Flavor

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 children
5 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)

LEADER COUGH DROPS MENTHOL FLAVOR 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5.4 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GLYCERIN 
ACACIA 
POTASSIUM SORBATE 
EUCALYPTUS OIL 
FD&C RED NO. 40 
CORN SYRUP 
SUCROSE 
WATER 
SOYBEAN OIL 
STARCH, CORN 
Product Characteristics
ColorblueScoreno score
ShapeOVAL (Oval) Size12mm
FlavorImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:49781-012-3030 LOZENGE (DROPS) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/25/2013
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
Bestco, Inc.002149136manufacture(49781-012)

 
Cardinal Health

Medically reviewed on Nov 27, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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