JAKEMANS PEPPERMINT- menthol lozenge 
Jakemans (Confectioners) Ltd.

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.

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Active Ingredient (in each lozenge)                                Purpose

Menthol 5mg ........ Antitussive (cough suppressant)/oral anesthetic

JAKEMANS® Boston ENGLAND Est 1907

Throat & Chest™ Peppermint Flavored Menthol Cough Suppressant Oral Anesthetic

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

30 Lozenges

Jakemans famous and original Throat & Chest Lozenges are made with the finest natural ingredients, carefully blended with soothing menthol to obtain a unique mouth watering and refreshing taste. Once tasted they will be your favorite soothing lozenge!

Manufactured by:

Jakemans (Confectioners) Ltd.

Boston PE20 2JA, United Kingdom

US Toll Free: 1-866-205-1185

www.jakemans.us

Keep out of reach of children.

Uses

Temporarily relieves

  • cough due to minor throat and bronchial 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 more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
sore mouth symptoms do not improve in 7 days.

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

Directions

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

Inactive Ingredients glucose syrup, peppermint oil (flavoring), sugar, water.

Questions & Comments?

To report serious adverse events, call: 1-866-205-1185

No added color

label image

JAKEMANS PEPPERMINT 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42637-823
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize30mm
FlavorPEPPERMINTImprint Code ol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42637-823-0130 in 1 PACKAGE; Type 0: Not a Combination Product12/11/201305/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/11/201305/30/2018
Labeler - Jakemans (Confectioners) Ltd. (218806669)
Establishment
NameAddressID/FEIBusiness Operations
Jakemans (Confectioners) Ltd.218806669manufacture(42637-823) , relabel(42637-823) , repack(42637-823)

Revised: 5/2018
 
Jakemans (Confectioners) Ltd.