Cold-eeze Cold Remedy

Cold-eeze Cold Remedy
SPL v2
SPL
SPL Set ID fb48a707-44f5-83b3-e053-6394a90a9470
Route
ORAL
Published
Effective Date 2022-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (13.3 mg) Glycyrrhiza Glabra (4.5 mg) Sambucus Nigra Flower (45 mg)
Inactive Ingredients
Glycine Sucrose Corn Syrup

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: oval Color: purple Size: 23 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-04-21

Description

Active ingredients (per lozenge ) . . . . . . . . . . . . . . . . . . . . . . Purposes Zinc Gluconate 2X HPUS† (2.22%) (13.3 mg zinc).................... Cold Remedy Sambucus Nigra 2X HPUS† (1.0%) ........................................... Relieves cough, nasal congestion and irritated respiratory tract* Glycyrrhiza Glabra (Licorice) 3X HPUS† (0.1%)......................... Relieves irritated throat* † 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

Active ingredients (per lozenge ) . . . . . . . . . . . . . . . . . . . . . . Purposes Zinc Gluconate 2X HPUS† (2.22%) (13.3 mg zinc).................... Cold Remedy Sambucus Nigra 2X HPUS† (1.0%) ........................................... Relieves cough, nasal congestion and irritated respiratory tract* Glycyrrhiza Glabra (Licorice) 3X HPUS† (0.1%)......................... Relieves irritated throat* † 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
  • temporarily relieves cough, nasal congestion, irritated respiratory tract and sore throat associated with cold and flu*
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 provide relief of cold and flu symptoms.

Section 51945-4

Cold-EEZE ®

COLD REMEDY

HOMEOPATHIC

Plus COLD & FLU SYMPTOM RELIEF*

HELPS RELIEVE Cough, Congestion, Sore Throat*

NATURAL MIXED BERRY FLAVOR

25 Lozenges

©2022 Vespyr Brands ®, Inc.

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
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

Questions?

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

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 2X HPUS† (2.22%) (13.3 mg zinc).................... Cold Remedy

Sambucus Nigra 2X HPUS† (1.0%) ........................................... Relieves cough, nasal congestion and irritated respiratory tract*

Glycyrrhiza Glabra (Licorice) 3X HPUS† (0.1%)......................... Relieves irritated throat*

† 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


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
  • temporarily relieves cough, nasal congestion, irritated respiratory tract and sore throat associated with cold and flu*
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 provide relief of cold and flu symptoms.

Section 51945-4 (51945-4)

Cold-EEZE ®

COLD REMEDY

HOMEOPATHIC

Plus COLD & FLU SYMPTOM RELIEF*

HELPS RELIEVE Cough, Congestion, Sore Throat*

NATURAL MIXED BERRY FLAVOR

25 Lozenges

©2022 Vespyr Brands ®, Inc.

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
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

Questions?

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

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

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

Zinc Gluconate 2X HPUS† (2.22%) (13.3 mg zinc).................... Cold Remedy

Sambucus Nigra 2X HPUS† (1.0%) ........................................... Relieves cough, nasal congestion and irritated respiratory tract*

Glycyrrhiza Glabra (Licorice) 3X HPUS† (0.1%)......................... Relieves irritated throat*

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

Inactive Ingredients (Inactive ingredients)

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


Advanced Ingredient Data


Raw Label Data

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