Your browser does not support JavaScript! THROAT AND CHEST CHILI AND LIME (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]
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THROAT AND CHEST CHILI AND LIME (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

label image

Drug FactsActive Ingredient (in each lozenge)...Purposes
Menthol 5mg.........Antitussive (cough suppressant) / oral anesthetic

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 may be a sign of a serious condition.
  • sore mouth symptoms do not improve in 7 days.

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

Glucose syrup, natural flavors, sugar, water.

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

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.

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

THROAT AND CHEST CHILI AND LIME 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42637-820
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (MENTHOL) Menthol5 mg
Inactive Ingredients
Ingredient NameStrength
Water 
CORN SYRUP 
SUCROSE 
Product Characteristics
ColorgreenScoreno score
ShapeOVAL (Lozenge) Size30mm
FlavorLIME (Natural Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42637-820-0130 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: 4/2013
 
Jakemans (Confectioners) Limited

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