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

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.


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 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

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

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.

Questions?

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

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

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.


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 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

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

Questions?

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

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

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.


Advanced Ingredient Data


Raw Label Data

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