Cold-eeze Cold Remedy Plus Defense*

SPL v2

SPL

SPL Set ID 02f6a97c-017c-234e-e063-6394a90afa37

Route

ORAL

Published

Effective Date 2023-04-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Sambucus Nigra Flower (50 mg) Avena Sativa Flowering Top (6.2 mg) Echinacea Purpurea (2 mg) Rosa Canina Fruit (4 mg) Zinc Cation (13.3 mg)

Inactive Ingredients

Glycine Sucrose Corn Syrup

Identifiers & Packaging

Pill Appearance

Imprint: P Shape: oval Color: brown Size: 23 mm

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2022-05-09

Description

Active ingredients (per lozenge ) . . . . . . . . . . . . . . . . . . . . . . Purposes Zinc Gluconate 1X HPUS † (2.22%) (13.3 mg zinc).................. Cold Remedy Sambucus Nigra 1X HPUS † (1.11%) ......................................... Promotes immune support* Avena Sativa L. 2X HPUS † (0.14%) ............................................ Helps with general debility and fatigue* Rosa Canina (Rose Hips) 2X HPUS † (0.09%) ........................ Promotes immune support* Echinacea Purpurea 3X HPUS † (0.04%) .................................. Promotes immune support* † The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

Purpose

Purposes

Medication Information

Purpose

Purposes

Description

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
supports immune system health*
helps with general debility and fatigue*

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 50569-3

Ask a doctor before use if you have

• diabetes • multiple sclerosis (MS) • rheumatoid arthritis (RA) or other auto-immune condition

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

HOMEOPATHIC

Plus DEFENSE*

PROMOTES Immune Health*

HELPS with Fatigue*

NATURAL FLAVOR CITRUS with ELDERBERRY

12 Lozenges

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

Distributed by Vespyr Brands ^®, Inc.

East Windsor, NJ 08520

This product has not been evaluated by the FDA

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 53414-9

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

Purposes

Purposes

Directions

• take one lozenge at the onset of symptoms • do not chew

• dissolve entire lozenge in mouth • 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

Active Ingredients

Active ingredients (per lozenge ) . . . . . . . . . . . . . . . . . . . . . . Purposes

Zinc Gluconate 1X HPUS ^† (2.22%) (13.3 mg zinc).................. Cold Remedy

Sambucus Nigra 1X HPUS ^† (1.11%) ......................................... Promotes immune support*

Avena Sativa L. 2X HPUS ^† (0.14%) ............................................ Helps with general debility and fatigue*

Rosa Canina (Rose Hips) 2X HPUS ^† (0.09%) ........................ Promotes immune support*

Echinacea Purpurea 3X HPUS ^† (0.04%) .................................. Promotes immune support*

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

Inactive Ingredients

corn syrup, glycine, natural colors, natural flavors, sucrose

Questions Or 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
supports immune system health*
helps with general debility and fatigue*

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 50569-3 (50569-3)

Ask a doctor before use if you have

• diabetes • multiple sclerosis (MS) • rheumatoid arthritis (RA) or other auto-immune condition

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

HOMEOPATHIC

Plus DEFENSE*

PROMOTES Immune Health*

HELPS with Fatigue*

NATURAL FLAVOR CITRUS with ELDERBERRY

12 Lozenges

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

Distributed by Vespyr Brands ^®, Inc.

East Windsor, NJ 08520

This product has not been evaluated by the FDA

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 53414-9 (53414-9)

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

Purposes

Purposes

Directions

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

Active Ingredients (Active ingredients)

Rosa Canina (Rose Hips) 2X HPUS ^† (0.09%) ........................ Promotes immune support*

Inactive Ingredients (Inactive ingredients)

corn syrup, glycine, natural colors, natural flavors, sucrose

Questions Or Comments? (Questions or comments?)

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

Advanced Ingredient Data

[{"name": "SAMBUCUS NIGRA FLOWER", "unii": "07V4DX094T", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "AVENA SATIVA FLOWERING TOP", "unii": "MA9CQJ3F7F", "classCode": "ACTIB", "strengthNumerator": "6.2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ECHINACEA PURPUREA", "unii": "QI7G114Y98", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ROSA CANINA FRUIT", "unii": "3TNW8D08V3", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIB", "strengthNumerator": "13.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GLYCINE", "unii": "TE7660XO1C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CORN SYRUP", "unii": "9G5L16BK6N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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 supports immune system health* helps with general debility and fatigue*", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask your doctor if symptoms persist more than 7 days", "50567-7": "When using this product do not take on an empty stomach (to avoid possible minor stomach upset)", "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.", "50569-3": "Ask a doctor before use if you have • diabetes • multiple sclerosis (MS) • rheumatoid arthritis (RA) or other auto-immune condition", "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.", "51945-4": "Cold-EEZE ® COLD REMEDY HOMEOPATHIC Plus DEFENSE* PROMOTES Immune Health* HELPS with Fatigue* NATURAL FLAVOR CITRUS with ELDERBERRY 12 Lozenges ©2023 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 This product has not been evaluated by the FDA *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.", "53414-9": "If pregnant or breastfeeding , ask a healthcare professional before use.", "Purposes": "Purposes", "Directions": "• take one lozenge at the onset of symptoms • do not chew • dissolve entire lozenge in mouth • 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", "Active ingredients": "Active ingredients (per lozenge ) . . . . . . . . . . . . . . . . . . . . . . Purposes Zinc Gluconate 1X HPUS † (2.22%) (13.3 mg zinc).................. Cold Remedy Sambucus Nigra 1X HPUS † (1.11%) ......................................... Promotes immune support* Avena Sativa L. 2X HPUS † (0.14%) ............................................ Helps with general debility and fatigue* Rosa Canina (Rose Hips) 2X HPUS † (0.09%) ........................ Promotes immune support* Echinacea Purpurea 3X HPUS † (0.04%) .................................. Promotes immune support* † The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.", "Inactive ingredients": "corn syrup, glycine, natural colors, natural flavors, sucrose", "Questions or comments?": "call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:45.589254 · Updated: 2026-03-14T23:17:09.150822