cold-eeze cold remedy sugar free cherry

cold-eeze cold remedy sugar free cherry
SPL v2
SPL
SPL Set ID 0326ab93-0b3b-7f29-e063-6294a90a01be
Route
oral
Published
Effective Date 2022-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (13.3 mg)
Inactive Ingredients
glycine isomalt acesulfame

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: oval Color: white Size: 23 mm
Marketing Status
unapproved homeopathic active Since 2022-06-29

Purpose

Cold remedy

Description

Active ingredient (per lozenge ) Zinc Gluconate 2X HPUS † (2.3%) (13.3 mg zinc) † The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.


Medication Information

Uses
  • reduces the duration of the common cold
  • reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
Purpose

Cold remedy

Directions

• take one lozenge at the onset of symptoms

• dissolve entire lozenge in mouth

• do not chew

• do not swallow whole

• do not eat or drink for 15 minutes after use

• repeat every 2-4 hours until symptoms subside

Adults 18 years and over do not exceed 6 lozenges per day
Children 12 to under 18 years do not exceed 4 lozenges per day
Children under 12 years ask a doctor before use

Other Information
  • store in a cool, dry place after opening
  • best if used within 6 months after opening
Inactive Ingredients

acesulfame-K, glycine, isomalt, natural flavors

Description

Active ingredient (per lozenge ) Zinc Gluconate 2X HPUS † (2.3%) (13.3 mg zinc) † The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask your doctor if symptoms persist more than 7 days

Section 50567-7

When using this product

  • do not take on an empty stomach (to avoid possible minor stomach upset)
  • it may cause a laxative effect
Section 50568-5

Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

Section 50570-1

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms.

Section 51945-4

Cold-EEZE ®

COLD REMEDY

ZINC GLUCONATE HOMEOPATHIC

SHORTENS YOUR COLD ®

SUGAR FREE

NATURAL WILD CHERRY FLAVOR

25 Zinc Lozenges

CLINICALLY TESTED to Shorten Colds by 42%*

Pharmacist Recommended

©2022 Vespyr Brands ®, Inc.

All rights reserved

Cold-EEZE ® is a registred trademark of Vespyr Brands ®, Inc.

Distributed by Vespyr Brands®, Inc.

East Windsor, NJ 08520

*A clinical study found the Cold-EEZE formula reduces the duration of the common cold by 42%, when taken at the first sign of symptoms and used as directed.

The double blind placebo controlled study was conducted at the Cleveland Clinic and published in a peer reviewed journal.

This product has not been evaluated by the FDA

Section 53414-9

If pregnant or breastfeeding, ask a healthcare professional before use.

Purposes

Cold remedy

Active Ingredient

Active ingredient (per lozenge )

Zinc Gluconate 2X HPUS (2.3%) (13.3 mg zinc)



The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

Questions of Comments?

call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)


Structured Label Content

Uses
  • reduces the duration of the common cold
  • reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness
Directions

• take one lozenge at the onset of symptoms

• dissolve entire lozenge in mouth

• do not chew

• do not swallow whole

• do not eat or drink for 15 minutes after use

• repeat every 2-4 hours until symptoms subside

Adults 18 years and over do not exceed 6 lozenges per day
Children 12 to under 18 years do not exceed 4 lozenges per day
Children under 12 years ask a doctor before use

Other Information (Other information)
  • store in a cool, dry place after opening
  • best if used within 6 months after opening
Inactive Ingredients (Inactive ingredients)

acesulfame-K, glycine, isomalt, natural flavors

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask your doctor if symptoms persist more than 7 days

Section 50567-7 (50567-7)

When using this product

  • do not take on an empty stomach (to avoid possible minor stomach upset)
  • it may cause a laxative effect
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

Section 50570-1 (50570-1)

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms.

Section 51945-4 (51945-4)

Cold-EEZE ®

COLD REMEDY

ZINC GLUCONATE HOMEOPATHIC

SHORTENS YOUR COLD ®

SUGAR FREE

NATURAL WILD CHERRY FLAVOR

25 Zinc Lozenges

CLINICALLY TESTED to Shorten Colds by 42%*

Pharmacist Recommended

©2022 Vespyr Brands ®, Inc.

All rights reserved

Cold-EEZE ® is a registred trademark of Vespyr Brands ®, Inc.

Distributed by Vespyr Brands®, Inc.

East Windsor, NJ 08520

*A clinical study found the Cold-EEZE formula reduces the duration of the common cold by 42%, when taken at the first sign of symptoms and used as directed.

The double blind placebo controlled study was conducted at the Cleveland Clinic and published in a peer reviewed journal.

This product has not been evaluated by the FDA

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a healthcare professional before use.

Purposes

Cold remedy

Active Ingredient (Active ingredient)

Active ingredient (per lozenge )

Zinc Gluconate 2X HPUS (2.3%) (13.3 mg zinc)



The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

Questions of Comments? (Questions of comments?)

call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)


Advanced Ingredient Data


Raw Label Data

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