dad63c46-13d9-46aa-bfa8-4f90c9553ea0 — v3

2 Views

Version

v3

Effective date

June 29, 2009

Original packager

Sections captured

14

Identifiers

Document ID
230f165f-67f8-462f-9099-87153625fbb9
Set ID
dad63c46-13d9-46aa-bfa8-4f90c9553ea0
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

Brand names
Generic names
Manufacturer names
Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredient (in each lozenge) menthol 5.5 mg
Ask Doctor (1)

Sequence 1

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)
Do Not Use (1)

Sequence 1

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.
Dosage And Administration (1)

Sequence 1

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 Ingredient (1)

Sequence 1

Inactive Ingredients acesulfame potassium, ascorbic acid, cherry flavor, FD&C red No. 40, isomalt, maltitol, purified water, sodium ascorbate, zinc gluconate
Indications And Usage (1)

Sequence 1

Uses temporarily relieves: occasional minor irritation, pain and sore throat and sore mouth cough associated with a cold or inhaled irritants
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

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 PRINCIPAL DISPLAY PANEL - Lozenge Bag
Purpose (1)

Sequence 1

Purposes Cough Suppressant/Oral Anesthetic
Questions (1)

Sequence 1

QUESTIONS? Call 1-800-344-7239 or visit us on the web at www.insightpharma.com
Spl Product Data Elements (1)

Sequence 1

Nice Cherry Menthol MENTHOL MENTHOL ACESULFAME POTASSIUM ASCORBIC ACID FD&C RED NO. 40 MALTITOL PROPYLENE GLYCOL WATER SODIUM ASCORBATE ZINC GLUCONATE N
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

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
Stop Use (1)

Sequence 1

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
Warnings (1)

Sequence 1

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.