Cold-eeze
FDA Label NDC 61941-0052

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prophase Labs, Inc. for the product Cold-eeze (NDC 61941-0052). 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 (per lozenge), purpose, uses, ask a doctor before use if you, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

COLD-EEZE® Lozenges are formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies.

  • gluten-free

Active Ingredient (Per Lozenge)

Zincum Gluconicum 2x (13.3mg)

Purpose

Cold Remedy

Uses

  • 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

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

Otc - Stop Use

Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.

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

  • 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

Other 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

Storage And Handling

  • store in a cool dry place after opening

Inactive Ingredients

corn syrup, glycine, natural flavors and sucrose. No artificial colors or preservatives.

Questions Or Comments

Call 1-800-505-COLD
(9AM-5PM EST)

Principal Display Panel - 18 Cherry Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

  • +Clinically proven to reduce the
    duration of the common cold
    ®
  • +#1 Pharmacist Recommended
  • +Shortens your cold, works fast
  • OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    18 Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Cherry Flavor
    with other natural flavors

    Principal Display Panel (18 Cherry Lozenge Carton)

    Principal Display Panel (18 Cherry Lozenge Carton)

Principal Display Panel - 24 Cherry Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

  • +Clinically proven to reduce the
    duration of the common cold
    ®
  • +#1 Pharmacist Recommended
  • +Shortens your cold, works fast
  • OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    24 Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Cherry Flavor
    with other natural flavors

    Principal Display Panel (24 Cherry Lozenge Carton)

    Principal Display Panel (24 Cherry Lozenge Carton)

Principal Display Panel - 18 Tropical Orange Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

  • +Clinically proven to reduce the
    duration of the common cold
    ®
  • +#1 Pharmacist Recommended
  • +Shortens your cold, works fast
  • OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    18 Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Tropical Orange Flavor
    with other natural flavors

    Principal Display Panel (18 Tropical Orange Lozenge Carton)

    Principal Display Panel (18 Tropical Orange Lozenge Carton)

Principal Display Panel - 24 Tropical Orange Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

  • +Clinically proven to reduce the
    duration of the common cold
    ®
  • +#1 Pharmacist Recommended
  • +Shortens your cold, works fast
  • OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    24 Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Tropical Orange Flavor
    with other natural flavors

    Principal Display Panel (24 Tropical Orange Lozenge Carton)

    Principal Display Panel (24 Tropical Orange Lozenge Carton)

Principal Display Panel - 18 Lemon Lime Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

  • +Clinically proven to reduce the
    duration of the common cold
    ®
  • +#1 Pharmacist Recommended
  • +Shortens your cold, works fast
  • OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    18 Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Lemon Lime Flavor
    with other natural flavors

    Principal Display Panel (18 Lemon Lime Lozenge Carton)

    Principal Display Panel (18 Lemon Lime Lozenge Carton)

Principal Display Panel - 24 Lemon Lime Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

  • +Clinically proven to reduce the
    duration of the common cold
    ®
  • +#1 Pharmacist Recommended
  • +Shortens your cold, works fast
  • OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    24 Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Lemon Lime Flavor
    with other natural flavors

    Principal Display Panel (24 Lemon Lime Lozenge Carton)

    Principal Display Panel (24 Lemon Lime Lozenge Carton)

Principal Display Panel - 18 Strawberries & Cream Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

  • +Clinically proven to reduce the
    duration of the common cold
    ®
  • +#1 Pharmacist Recommended
  • +Shortens your cold, works fast
  • OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    18 Cold Remedy
    Lozenges

    Homeopathic

    All Natural Strawberries
    & Cream Flavor
    with other natural flavors

    Principal Display Panel (18 Strawberries & Cream Lozenge Carton)

    Principal Display Panel (18 Strawberries & Cream Lozenge Carton)

Principal Display Panel - 24 Strawberries & Cream Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

  • +Clinically proven to reduce the
    duration of the common cold
    ®
  • +#1 Pharmacist Recommended
  • +Shortens your cold, works fast
  • OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    24 Cold Remedy
    Lozenges

    Homeopathic

    All Natural Strawberries
    & Cream Flavor
    with other natural flavors

    Principal Display Panel (24 Strawberries & Cream Lozenge Carton)

    Principal Display Panel (24 Strawberries & Cream Lozenge Carton)

Principal Display Panel - 18 Mint Frost Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

COLD REMEDY

  • +Clinically proven to reduce the
    duration of the common cold
    ®
  • +#1 Pharmacist Recommended
  • +Shortens your cold, works fast
  • OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    18 Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Mint Frost Flavor
    with other natural flavors

    Principal Display Panel (18 Mint Frost Lozenge Carton)

    Principal Display Panel (18 Mint Frost Lozenge Carton)

Principal Display Panel - 24 Mint Frost Lozenge Carton

GREAT
NEW TASTE

Cold-EEZE®
Zinc Gluconate Glycine

33%
MORE
FREE

COLD REMEDY

  • +Clinically proven to reduce the
    duration of the common cold
    ®
  • +#1 Pharmacist Recommended
  • +Shortens your cold, works fast
  • OTC Master's Circle
    Achievement Award
    #1
    Pharmacist
    Recommended
    Brand!
    Pharmacy
    Times

    24 Cold Remedy
    Lozenges

    Homeopathic

    All Natural
    Mint Frost Flavor
    with other natural flavors

    Principal Display Panel (24 Mint Frost Lozenge Carton)

    Principal Display Panel (24 Mint Frost Lozenge Carton)

* Please review the disclaimer below.