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Insight Pharmaceuticals

N'ICE Cubes


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient (in each lozenge)

menthol 5.5 mg

Purposes

Cough Suppressant/Oral Anesthetic

Nice 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, cherry flavor, FD&C red No. 40, isomalt, maltitol, 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.

64804A

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

Cherry

25 LOZENGES

Nice

Nice

Menthol LOZENGE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-502
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 5.5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ASCORBIC ACID
FD&C RED NO. 40
MALTITOL
propylene glycol
water
sodium ascorbate
ZINC GLUCONATE

Product Characteristics

Color Size Imprint Code Shape
PINK 19 mm N SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63736-502-25 25 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2009-06-25


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Be sure to consult your doctor before taking any medication!
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