Nbe Cool Mint
FDA Label NDC 64762-884

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynamic Pharmaceuticals Inc. for the product Nbe Cool Mint (NDC 64762-884). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

    • 25
    Quick dissolving
    tablets

    Principal Display Panel (25 Tablet Bottle Carton)

    Principal Display Panel (25 Tablet Bottle Carton)

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