Zinc gluconate

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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
- to reduce the duration of the common cold
- reduces the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness

### 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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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
- are taking minocycline, doxycycline, tetracycline or are on coumadin therapy,
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
- are taking minocycline, doxycycline, tetracycline or are on coumadin therapy,
- zinc treatment may inhibit the absorption of these medicines

# 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

## 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
GREAT
NEW TASTE
Cold-EEZE 
Zinc Gluconate Glycine
COLD REMEDY
SUGAR FREE
OTC Master's Circle
Achievement Award
Pharmacist
Recommended
Brand!
Pharmacy
Times
Clinically proven to reduce the 
duration of the common cold 
- 1 Pharmacist Recommended
Shortens your cold, works fast
Cold Remedy
Lozenges
Homeopathic
All Natural
Wild Cherry Flavor
with other natural flavors
GREAT
NEW TASTE
Cold-EEZE 
Zinc Gluconate Glycine
MORE
FREE
COLD REMEDY
SUGAR FREE
OTC Master's Circle
Achievement Award
Pharmacist
Recommended
Brand!
Pharmacy
Times
Clinically proven to reduce the 
duration of the common cold 
- 1 Pharmacist Recommended
Shortens your cold, works fast
Cold Remedy
Lozenges
Homeopathic
All Natural
Wild Cherry Flavor
with other natural flavors

# 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
- Cold-EEZE

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

# Drug Shortage Status

# Price