NICE MENTHOL- menthol lozenge
Insight Pharmaceuticals LLC

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.

----------

N'ICE®

Drug Facts

Active Ingredient (in each lozenge)

menthol 5 mg

Purposes

Cough Suppressant/Oral Anesthetic

Uses

temporarily suppresses/relieves:

coughs due to minor throat and bronchial irritation from a cold or inhaled irritants
occasional minor sore throat pain

Warnings

Ask a doctor before use if you have

chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
cough that occurs with too much phlegm (mucus)

When using this product

do not use more than directed, taking more may have a laxative effect

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting
sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens

Keep out of reach of children.

Directions

dissolve a lozenge slowly in mouth
may be repeated every hour for coughs as needed or as directed by a doctor
may be repeated every 2 hours for sore throat
do not take more than 10 lozenges per day

adults and children 6 years and older	5 mg
children under 6 years	ask a doctor

Inactive Ingredients

Acesulfame Potassium, Citric Acid, Eucalyptus Oil, Isomalt, Other N&A Flavors

QUESTIONS?

Call 1-800-344-7239 or visit us on the web at www.insightpharma.com

Distributed by:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 24 Lozenges Box

N'ICE®
SUGAR FREE
DIABETIC-SAFE

ƒor Coughs
and Minor Sore
Throat Pain
MENTHOL • COUGH SUPPRESSANT/ORAL ANESTHETIC

Menthol
EUCALYPTUS

24 LOZENGES

NICE MENTHOL
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63736-948
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Product Characteristics
Color	GREEN (light green)	Score	no score
Shape	ROUND	Size	19mm
Flavor	MENTHOL	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63736-948-24	24 in 1 BOX; Type 0: Not a Combination Product	07/28/2009	08/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	07/28/2009	08/31/2017

Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 1/2010

Document Id: 521b8ffa-17e8-429c-9fe8-bca3f9d4b4e5

Set id: 2ffd13a1-12d6-4a1f-805f-efaaf8264365

Version: 4

Effective Time: 20100111

Insight Pharmaceuticals LLC