JAKEMANS THROAT AND CHEST PEPPERMINT- menthol lozenge

Jakemans Throat and Chest Peppermint by

Drug Labeling and Warnings

Jakemans Throat and Chest Peppermint by is a Otc medication manufactured, distributed, or labeled by Jakemans (Confectioners) Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each lozenge)                                Purpose

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

PURPOSE

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

Keep out of reach of children.

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

OTHER SAFETY INFORMATION

Questions & Comments?

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

No added color

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JAKEMANS THROAT AND CHEST PEPPERMINT 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42637-824
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	30mm
Flavor	PEPPERMINT	Imprint Code	ol
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42637-824-01	30 in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2013
2	NDC: 42637-824-02	24 in 1 PACKAGE; Type 0: Not a Combination Product	12/11/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/11/2013

Labeler - Jakemans (Confectioners) Ltd. (218806669)

Establishment
Name	Address	ID/FEI	Business Operations
Jakemans (Confectioners) Ltd.		218806669	manufacture(42637-824) , relabel(42637-824) , repack(42637-824)