HONIBE by Island Abbey Foods Ltd. HONIBE- menthol lozenge

HONIBE by

Drug Labeling and Warnings

HONIBE by is a Otc medication manufactured, distributed, or labeled by Island Abbey Foods Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

MENTHOL

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

PURPOSE

TEMPORARILY RELIEVES:

COUGH DUE TO COLD

OCCASIONAL MINOR IRRITATION OR SORE THROAT

DOSAGE & ADMINISTRATION

ORAL LOZENGE

INACTIVE INGREDIENT

HONEY, EUCALYPTUS OIL

INDICATIONS & USAGE

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.

WARNINGS

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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.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

HONIBE 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50788-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.6 mg  in 2.5 g

Inactive Ingredients
Ingredient Name	Strength
HONEY (UNII: Y9H1V576FH)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Product Characteristics
Color	yellow (honey yellow)	Score	no score
Shape	ROUND (Lozenge)	Size	16mm
Flavor	LEMON (LEMON OIL)	Imprint Code	raised;flower
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50788-001-02	1 in 1 BAG
1	NDC: 50788-001-01	25 g in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/30/2012

Labeler - Island Abbey Foods Ltd. (243869661)

Establishment
Name	Address	ID/FEI	Business Operations
Island Abbey Foods Ltd.		243869661	manufacture