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Name:Nicecherry
Manufacturer:Insight Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


N'ICE®

NICE CHERRY - 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®

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, Eucalyptus Oil, FD&C Blue No.1, FD&C Red No.40, Isomalt, N&A Cherry Flavor, Other N&A Flavors, Tartaric Acid

Isomalt is a diabetic safe sweetener. Retain outer carton for complete directions and warnings. Each lozenge is safety-sealed in a blister pack for your protection. Use only if lozenge blister seals are unbroken. 10 calories per lozenge. Avoid storing at high temperature (greater than 100°F).

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 - 8 Lozenge Box

N'ICE®
MENTHOL • COUGH SUPPRESSANT/ORAL ANESTHETIC

ƒor Coughs and Minor Sore Throat Pain

SUGAR FREE
DIABETIC-SAFE

Cherry

8 LOZENGES

Principle Display Panel - 8 Lozenge Box

NICE  CHERRY
menthol lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-860
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 5 mg
Inactive Ingredients
Ingredient Name Strength
Acesulfame Potassium  
Eucalyptus Oil  
FD&C Blue No. 1  
FD&C Red No. 40  
Tartaric Acid  
Product Characteristics
Color RED Score no score
Shape ROUND Size 19mm
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-860-08 8 LOZENGE ( LOZENGE) in 1 BOX None
2 NDC:63736-860-24 24 LOZENGE ( LOZENGE) in 1 BOX None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/28/2009

Labeler - Insight Pharmaceuticals (176792315)

Revised: 03/2010 Insight Pharmaceuticals



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


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