Throat and Chest Anise and Menthol

THROAT AND CHEST ANISE AND MENTHOL- menthol lozenge
Jakemans (Confectioners) Limited

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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JAKEMANS
Boston ENGLAND
EST 1907

Throat and Chest

Anise 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.

Inactive Ingredients anise oil (flavoring), caramel color, eucalyptus oil (flavoring), glucose syrup, natural flavor, sugar, water.

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

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.

THROAT AND CHEST ANISE AND MENTHOL
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42637-810
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	5 mg

Inactive Ingredients
Ingredient Name	Strength
Anise Oil
Eucalyptus Oil
Caramel
Malic Acid
Sucrose
Water

Product Characteristics
Color	black (Caramel (black))	Score	no score
Shape	OVAL (Lozenge)	Size	30mm
Flavor	ANISE (Anise Flavoring)	Imprint Code	ol
Contains

Packaging
#	Item Code	Package Description
1	NDC:42637-810-01	24 in 1 BOX
2	NDC:42637-810-02	30 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/13/2011

Labeler - Jakemans (Confectioners) Limited (218806669)