Label: NBE COOL MINT COLD REMEDY FAST MELTING- zinc gluconate lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 64762-884-25 - Packager: Dynamic Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated August 24, 2011
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each tablet)
- Purpose
- Uses
- Warnings
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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
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton
CVS®
pharmacyCompare to
the active ingredient
in Zicam® Rapid Melts®
Cold Remedy PLUS†NEW!
COLD
REMEDY
PLUS
FAST MELTINGZINC GLUCONICUM
Cool Mint
HomeopathicTake 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 -
Reduces the duration &
-
INGREDIENTS AND APPEARANCE
NBE COOL MINT COLD REMEDY FAST MELTING
zinc gluconate lozengeProduct 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