Cold-eeze Cold Remedy Ultramelt Chews

Cold-eeze Cold Remedy Ultramelt Chews
SPL v2
SPL
SPL Set ID 04b6992d-c7c5-56c7-e063-6394a90ae8d0
Route
ORAL
Published
Effective Date 2023-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (13.3 mg)
Inactive Ingredients
Glycine Sucralose Acesulfame Potassium Xylitol Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Isomalt Fd&c Yellow No. 5 Aluminum Lake Erythritol Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Imprint: C Shape: round Color: white Size: 11 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-07-01

Description

Active ingredient (per tablet ) Zinc Gluconate 1X HPUS † (2.22%) (13.3 mg zinc) † The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

Purpose

Cold remedy


Medication Information

Purpose

Cold remedy

Description

Active ingredient (per tablet ) Zinc Gluconate 1X HPUS † (2.22%) (13.3 mg zinc) † The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

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
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)

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 ®

UltraMELT ® Chews

GREAT Tasting

QUICK DISSOLVING Tablets

NATURAL ORANGE FLAVOR

24 Chewable Tablets

©2022 Vespyr Brands ®, Inc.

Cold-EEZE ® and ULTRAMELT ® are registered trademarks of Vespyr Brands ®, Inc.

Distributed by Vespyr Brands ®, Inc.

East Windsor, NJ 08520 USA

This product has not been evaluated by the FDA

Made in Denmark

www.coldeeze.com

Section 53414-9

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

Purposes

Cold remedy

Directions

• take one chewable tablet at the onset of symptoms • chew slowly and dissolve completely in mouth before swallowing

• 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 chewable tablets per day
Children 12 to under 18 years do not exceed 4 chewable tablets per day
Children under 12 years ask a doctor before use

Questions?

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

Active Ingredient

Active ingredient (per tablet )

Zinc Gluconate 1X HPUS (2.22%) (13.3 mg zinc)



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

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

acesulfame potassium, erythritol, FD&C red no. 40 aluminum lake, FD&C yellow No. 5 (tartrazine) aluminum lake, glycine, hydroxypropyl cellulose, isomalt, magnesium stearate, natural flavors, sucarlose, xylitol


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
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)

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 ®

UltraMELT ® Chews

GREAT Tasting

QUICK DISSOLVING Tablets

NATURAL ORANGE FLAVOR

24 Chewable Tablets

©2022 Vespyr Brands ®, Inc.

Cold-EEZE ® and ULTRAMELT ® are registered trademarks of Vespyr Brands ®, Inc.

Distributed by Vespyr Brands ®, Inc.

East Windsor, NJ 08520 USA

This product has not been evaluated by the FDA

Made in Denmark

www.coldeeze.com

Section 53414-9 (53414-9)

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

Purposes

Cold remedy

Directions

• take one chewable tablet at the onset of symptoms • chew slowly and dissolve completely in mouth before swallowing

• 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 chewable tablets per day
Children 12 to under 18 years do not exceed 4 chewable tablets per day
Children under 12 years ask a doctor before use

Questions?

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

Active Ingredient (Active ingredient)

Active ingredient (per tablet )

Zinc Gluconate 1X HPUS (2.22%) (13.3 mg zinc)



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

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 potassium, erythritol, FD&C red no. 40 aluminum lake, FD&C yellow No. 5 (tartrazine) aluminum lake, glycine, hydroxypropyl cellulose, isomalt, magnesium stearate, natural flavors, sucarlose, xylitol


Advanced Ingredient Data


Raw Label Data

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