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Insight Pharmaceuticals

N'ICE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient (in each lozenge)

menthol 5 mg

Purposes

Cough Suppressant/Oral Anesthetic

Nice 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, D&C Yellow No.10, Eucalyptus Oil, Isomalt, Lemon Oil, Other N&A Flavors, Sodium Citrate

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

Citrus

24 LOZENGES

Nice

Nice

Menthol LOZENGE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-594
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
CITRIC ACID MONOHYDRATE
D&C YELLOW NO. 10
EUCALYPTUS OIL
SODIUM CITRATE

Product Characteristics

Color Size Shape
YELLOW 19 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63736-594-24 24 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2009-07-16


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Be sure to consult your doctor before taking any medication!
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