Zinc gluconate

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Zinc gluconate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Zinc gluconate is a lozenge that is FDA approved for the treatment of common cold. It reduces the severity of cold symptoms. Common adverse reactions include stomach upset.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

DIRECTIONS

  • adults and children 12 years and over
  • for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
  • repeat every 2 - 4 hours as needed until all symptoms subside
  • completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)
  • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
  • children under 12 years of age should consult a health professional prior to use

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Zinc gluconate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Zinc gluconate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Zinc gluconate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Zinc gluconate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Zinc gluconate in pediatric patients.

Contraindications

There is limited information regarding Zinc gluconate Contraindications in the drug label.

Warnings

  • Ask a doctor before use if you

zinc treatment may inhibit the absorption of these medicines

  • Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.
  • COLD-EEZE® Lozenges are formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies.
  • Diabetic Warning: sugar replacements may affect blood sugar levels.
  • If pregnant or breast-feeding, ask a health professional before use.
  • Keep out of reach of children.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Zinc gluconate in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Zinc gluconate in the drug label.

Drug Interactions

  • Ask a doctor before use if you

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Zinc gluconate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Zinc gluconate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Zinc gluconate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Zinc gluconate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Zinc gluconate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Zinc gluconate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Zinc gluconate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Zinc gluconate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Zinc gluconate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Zinc gluconate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Zinc gluconate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • completely dissolve a COLD-EEZE® lozenge in mouth (do not chew)

Monitoring

There is limited information regarding Monitoring of Zinc gluconate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Zinc gluconate in the drug label.

Overdosage

There is limited information regarding Overdose of Zinc gluconate in the drug label.

Pharmacology

This image is taken from WikiPedia

Mechanism of Action

Structure

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Zinc gluconate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Zinc gluconate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Zinc gluconate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Zinc gluconate in the drug label.

How Supplied

There is limited information regarding Zinc gluconate How Supplied in the drug label.

Storage

  • store in a cool dry place after opening

Images

Drug Images

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 18 LOZENGE WILD CHERRY CARTON

GREAT NEW TASTE

Cold-EEZE® Zinc Gluconate Glycine

COLD REMEDY

SUGAR FREE

OTC Master's Circle Achievement Award

  1. 1

Pharmacist Recommended Brand! Pharmacy Times

Clinically proven to reduce the duration of the common cold ®

  1. 1 Pharmacist Recommended

Shortens your cold, works fast 18 Cold Remedy Lozenges

Homeopathic

All Natural Wild Cherry Flavor with other natural flavors

Zinc Gluconate PDP 18.png
PRINCIPAL DISPLAY PANEL - 24 LOZENGE WILD CHERRY CARTON

GREAT NEW TASTE

Cold-EEZE® Zinc Gluconate Glycine

33% MORE FREE

COLD REMEDY

SUGAR FREE

OTC Master's Circle Achievement Award

  1. 1

Pharmacist Recommended Brand! Pharmacy Times

Clinically proven to reduce the duration of the common cold ®

  1. 1 Pharmacist Recommended

Shortens your cold, works fast 24 Cold Remedy Lozenges

Homeopathic

All Natural Wild Cherry Flavor with other natural flavors

Zinc Gluconate PDP 24.png
Ingredients and Appearance
Zinc Gluconate Ing and App.png

Patient Counseling Information

  • avoid minor stomach upset - Do not dissolve COLD-EEZE® lozenges on an empty stomach
  • avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking COLD-EEZE® lozenges as they may diminish product effectiveness, otherwise, drink plenty of fluids
  • store in a cool dry place after opening
  • gluten-free
  • product may produce a laxative effect

Precautions with Alcohol

  • Alcohol-Zinc gluconate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Zinc gluconate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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