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.

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.

• 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

• 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

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

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

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

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

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

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

• 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.

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

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

• 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

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.

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

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

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

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

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

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

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

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

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

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

• Oral

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

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

• Description

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

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

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

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

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

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

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

• store in a cool dry place after opening

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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

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

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• 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

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

• Cold-EEZE®^[1]

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

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