Your browser does not support JavaScript! THROAT AND CHEST CHERRY AND MENTHOL (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]
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THROAT AND CHEST CHERRY 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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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 or 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.

Inactive Ingredients

carmine (color), glucose syrup, lactic acid, natural flavor, sodium lactate, sugar, water.

Questions and Comments?

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

THROAT AND CHEST CHERRY AND MENTHOL 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42637-811
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (MENTHOL) Menthol5 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP 
Water 
Lactic Acid 
SODIUM LACTATE 
SUCROSE 
Product Characteristics
Colorred (CARMINE) Scoreno score
ShapeOVAL (Lozenge) Size30mm
FlavorCHERRY (Natural Flavor) Imprint Code ol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42637-811-0124 in 1 BOX
2NDC:42637-811-0230 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/13/201106/01/2014
Labeler - Jakemans (Confectioners) Limited (218806669)

Revised: 12/2013
 
Jakemans (Confectioners) Limited

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