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Insight Pharmaceuticals

NICE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient (in each lozenge)

menthol 5 mg

Purposes

Cough Suppressant/Oral Anesthetic

Nice Assorted 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, Ascorbic Acidmay contain one or more of these ingredients, Caramel Colormay contain one or more of these ingredients, Citric Acidmay contain one or more of these ingredients, D&C Yellow No.10may contain one or more of these ingredients, Eucalyptus Oil, FD&C Blue No.1may contain one or more of these ingredients, FD&C Red No.40may contain one or more of these ingredients, FD&C Yellow No.6may contain one or more of these ingredients, Isomalt, N&A Flavors, Sodium Citratemay contain one or more of these ingredients, Tartaric Acidmay contain one or more of these ingredients

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 - 24 Lozenge Box

N'ICE®
SUGAR FREE
DIABETIC-SAFE

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

Assorted

24 LOZENGES

Nice Assorted

Nice Assorted

menthol LOZENGE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-859
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
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
D&C YELLOW NO. 10
EUCALYPTUS OIL
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
SODIUM CITRATE
tartaric acid

Product Characteristics

Color Size Shape
WHITE 19 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63736-859-24 24 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2009-07-28


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Be sure to consult your doctor before taking any medication!
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