Your browser does not support JavaScript! THROAT AND CHEST HONEY LEMON AND MENTHOL (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]
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THROAT AND CHEST HONEY LEMON AND MENTHOL (menthol) lozenge
[Jakemans (Confectioners) Limited]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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JAKEMANS
Boston ENGLAND
EST 1907

Throat and Chest

Honey and Lemon Flavored
With other Natural Flavor
Menthol Cough Suppressant
Oral Anesthetic

Made in Boston, England, for over 100 years
using the finest natural ingredients

24 LOZENGES

Drug Facts
Active Ingredient (in each lozenge)...Purpose
Menthol 5mg.........Antitussive (cough suppressant) / oral anesthetic

Uses Temporarily relieves
  • cough due to minor throat and brochial irritation occurring with the common cold or inhaled irritants.
  • occasional minor irritation, pain, sore mouth, and sore throat.

Warnings
Sore throat warning.If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have
  • persistent or chronic cough as occurs with smoking, asthma or emphysema.
  • cough that occurs with excessive phlegm (mucus).

Stop use and ask a doctor if
  • cough persists for man than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough mat be a sign of a serious condition.
  • sore mouth symptoms do not improve in 7 days.

If pregnant of breast-feeding,ask a health professional before use.

Keep out of reach of children.

Directions
  • adults and children 2 years and over dissolve lozenge slowly in the mouth. Repear every 2 hours as needed or as directed by a doctor.
  • children under 2 years of age ask a doctor.

Questions and Comments?
To report serious adverse enets, call: 1-866-205-1185

Inactive Ingredients beta carotene (coloring), glucose syrup, honey, lactic acid, lemon oil (flavoring), natural flavor), sodium lactate, sugar, water.
THROAT AND CHEST HONEY LEMON AND MENTHOL 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42637-813
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (MENTHOL) Menthol5 mg
Inactive Ingredients
Ingredient NameStrength
Honey 
Lemon Oil 
Beta Carotene 
Lactic Acid 
Water 
Sucrose 
CORN SYRUP 
Product Characteristics
Coloryellow (Beta Carotene) Scoreno score
ShapeOVAL (Lozenge) Size30mm
FlavorHONEY (Natural flavor) , LEMON (Lemon Oil) Imprint Code ol
Contains    
Packaging
#Item CodePackage Description
1NDC:42637-813-0124 in 1 BOX
2NDC:42637-813-0230 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/13/2011
Labeler - Jakemans (Confectioners) Limited (218806669)

Revised: 02/2013
Document Id: bf1fdce9-c418-4917-820b-f65776a03c51
Set id: 1edbf2f1-5c85-4b37-a8f1-f66bd8918eff
Version: 8
Effective Time: 20130214
 
Jakemans (Confectioners) Limited

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