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Name:Nice Cool Mint
Manufacturer:Insight Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


N'ICE® CUBES

NICE  COOL MINT - menthol lozenge 
Insight Pharmaceuticals

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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N'ICE® CUBES

Drug Facts

Active Ingredient (in each lozenge)

menthol 8 mg

Purposes

Cough Suppressant/Oral Anesthetic

Uses

temporarily relieves:

  • occasional minor irritation, pain and sore throat and sore mouth
  • cough associated with a cold or inhaled irritants

Warnings

Sore throat warning: severe or persistent sore throat or sore throat that occurs with or is followed by high fever, headache, rash, swelling and nausea and vomiting may be serious. Ask doctor right away. Do not use more than 2 days or give to children under 3 years of age unless directed by a doctor.

Ask a doctor before use if you have

  • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
  • swelling, rash or fever develops

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 3 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor. Do not take more than 10 lozenges a day.
  • children under 3 years of age: ask a dentist or doctor.

Inactive Ingredients

acesulfame potassium, ascorbic acid, FD&C blue No. 1, isomalt, maltitol, peppermint, purified water, sodium ascorbate, zinc gluconate

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

©2006 INSIGHT Pharmaceuticals Corp.
N'ICE penguin design and overall packaging design elements are trademarks of INSIGHT Pharmaceuticals Corp.

64803A

PRINCIPAL DISPLAY PANEL - Lozenge Bag

N'ICE®
Cubes
SUGAR FREE
DIABETIC-SAFE

ƒor Coughs and Minor
Sore Throat Pain

MENTHOL • COUGH SUPPRESSANT/ORAL ANESTHETIC

contains Vitamin C
and Zinc

Cool Mint

25 LOZENGES

PRINCIPAL DISPLAY PANEL - Lozenge Bag

NICE   COOL MINT
menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-028
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 8 mg
Inactive Ingredients
Ingredient Name Strength
acesulfame potassium  
ascorbic acid  
FD&C Blue No. 1  
maltitol  
peppermint  
propylene glycol  
sodium ascorbate  
zinc gluconate  
water  
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape SQUARE Size 19mm
Flavor MINT Imprint Code N
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-028-25 25 LOZENGE ( LOZENGE) in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 06/05/2009

Labeler - Insight Pharmaceuticals (176792315)

Revised: 06/2009 Insight Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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