NBE COOL MINT COLD REMEDY FAST MELTING- zinc gluconate lozenge

NBE Cool Mint by

Drug Labeling and Warnings

NBE Cool Mint by is a Homeopathic medication manufactured, distributed, or labeled by Dynamic Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient (in each tablet)

Zincum Gluconicum 1X

Purpose

Reduces duration and severity of the common cold

Uses

• Reduces duration of common cold
• Reduces severity of cold symptoms: stuffy nose, sneezing, sore throat, coughing, and congestion

Warnings

• Stop use and ask doctor if
  • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
• Cold Remedy PLUS is formulated to reduce the duration and severity of the common cold and may not be effective for flu or allergies.

Stop use and ask a doctor if symptoms persist.

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

Directions

For Adults and Children 12 years old and older:

Note: For maximum benefit, begin treatment at first sign of cold.

• Completely dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
• Take one tablet at the onset of symptoms.
• Repeat every three hours until symptoms are gone, up to 5 tablets per day.
• For best results, use for an additional 48 hours after symptoms subside.
• To avoid minor stomach upset, do not take on an empty stomach.
• Do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.

For Children under 12 years of age, consult a physician before use.

Inactive Ingredients

Copovidone, Crospovidone, Magnesium Stearate, Mannitol, Menthol, Mono-Ammonium Glycyrrhizinate, Natural and Artificial Flavors, Silicon Dioxide, Sodium Starch Glycolate, Sorbitol, Stearic Acid, Sucralose

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Distributed by:
CVS Pharmacy, Inc.
One CVS Drive,
Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

CVS®
pharmacy

Compare to
the active ingredient
in Zicam® Rapid Melts®
Cold Remedy PLUS†

NEW!

COLD
REMEDY
PLUS
FAST MELTING

ZINC GLUCONICUM

Cool Mint
Homeopathic

Take at the first
sign of a cold

• Reduces the duration &
  severity of the common cold
• Menthol helps relieve stuffy nose
• No metallic aftertaste

25
Quick dissolving
tablets

INGREDIENTS AND APPEARANCE

NBE COOL MINT   COLD REMEDY FAST MELTING
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64762-884
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC - UNII:J41CSQ7QDS)	ZINC GLUCONATE	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Menthol (UNII: L7T10EIP3A)
Copovidone K25-31 (UNII: D9C330MD8B)
Crospovidone (UNII: 68401960MK)
Magnesium Stearate (UNII: 70097M6I30)
Mannitol (UNII: 3OWL53L36A)
Ammonium Glycyrrhizate (UNII: 3VRD35U26C)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)
Sorbitol (UNII: 506T60A25R)
Stearic Acid (UNII: 4ELV7Z65AP)
Sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	7mm
Flavor	MINT	Imprint Code	CH
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64762-884-25	1 in 1 CARTON
1		25 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		08/01/2011

Labeler - Dynamic Pharmaceuticals Inc. (617660712)

Establishment
Name	Address	ID/FEI	Business Operations
Dynamic Pharmaceuticals Inc.		617660712	MANUFACTURE