KEPTRILS- menthol lozenge
MAGVERZ INC

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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Keptril

Actives

Menthol 5mg in each Lozenge

Inactives

Honey, Citric Acid, Hyssop,Eucalyptus oil, Long pepper

Purpose

Oral Analgesic

Uses

Sore throat pain

Sore mouth

Minor mouth irritation

Directions

Adults and childrens 6 years older: allow lozene to dissolve slowly in the mouth; may be repeated every two hours as nedded or as directed by doctor or dentist .

Childrens under 6 years of age; do not use.

Warnings

Sore throat warninings : Server or persistent sore throat or sore throat accomapnied by high fever headache,nausea and vomittin may be serious. Consult a doctor promptly. Do not use for more than two days or gice to children under 6 years of age.

Keep out of reach of children

Keep this and all drugs out of reach of children

Product Label

keptril

KEPTRILS
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59240-004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg

Ingredient Name	Strength
Inactive Ingredients
HONEY (UNII: Y9H1V576FH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYSSOP OIL (UNII: 173D71924B)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LONG PEPPER (UNII: 2NMG4EA7B1)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	24mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59240-004-01	24 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/03/2015

Labeler - MAGVERZ INC (078712269)