HONIBE

Dosage form: lozenge
Ingredients: MENTHOL 8.6mg in 2.5g
Labeler: Island Abbey Foods Ltd.
NDC Code: 50788-001

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.

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL8.6 mg  in 2.5 g
Inactive Ingredients
Ingredient NameStrength
HONEY 
EUCALYPTUS OIL 
Product Characteristics
Coloryellow (honey yellow) Scoreno score
ShapeROUND (Lozenge) Size16mm
FlavorLEMON (LEMON OIL) Imprint Coderaised;flower
Contains    
Packaging
#Item CodePackage Description
1NDC:50788-001-021 BLISTER PACK (BLISTER PACK) 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/FEIOperations
Island Abbey Foods Ltd.243869661manufacture

Revised: 06/2012
 
Island Abbey Foods Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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