HONIBE - menthol lozenge 
Island Abbey Foods 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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DRUG FACTS

MENTHOL


KEEP OUT OF REACH OF CHILDREN

TEMPORARILY RELIEVES:

COUGH DUE TO COLD

OCCASIONAL MINOR IRRITATION OR SORE THROAT



ORAL LOZENGE

HONEY, EUCALYPTUS OIL

ADULTS AND CHILDREN 5 YEARS AND OVER:

DISSOLVE 1 DROP SLOWLY IN MOUTH. REPEAT EVERY 2 HOURS AS NEEDED.

CHILDREN UNDER 5 CONSULT  YOUR DOCTOR.

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IF SORE THROAT IS SEVERE, PERSIST FOR MORE THAN 2 DAYS OR IS ACCOMPANIED  OR FOLLOWED BY FEVER HEADACHE,RASH,SWELLING,NAUSEA,VOMITING, CONSULT A DOCTOR PROMPTLY.

THESE SYMPTOMS MAY BE SERIOUS.

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HONIBE 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50788-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.6 mg  in 2.5 g
Inactive Ingredients
Ingredient NameStrength
HONEY (UNII: Y9H1V576FH)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Product Characteristics
Coloryellow (honey yellow) Scoreno score
ShapeROUND (Lozenge) Size16mm
FlavorLEMON (LEMON OIL) Imprint Code raised;flower
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50788-001-021 in 1 BAG
1NDC:50788-001-0125 g in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/30/2012
Labeler - Island Abbey Foods Ltd. (243869661)
Establishment
NameAddressID/FEIBusiness Operations
Island Abbey Foods Ltd.243869661manufacture

Revised: 6/2012
Document Id: 1aa56720-08e1-42ab-b722-24c5f6ed9d15
Set id: d3645082-eb83-4a27-9dfe-79093dbe35ee
Version: 3
Effective Time: 20120627
 
Island Abbey Foods Ltd.