FDA Label for Nbe Cool Mint Cold Remedy Fast Melting

View Indications, Usage & Precautions

Nbe Cool Mint Cold Remedy Fast Melting Product Label

The following document was submitted to the FDA by the labeler of this product Dynamic Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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


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

Otc - Stop Use



  • 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.


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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


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

* Please review the disclaimer below.