First Aid Direct Cold-eeze cold Remedy

First Aid Direct Cold-eeze cold Remedy
SPL v5
SPL
SPL Set ID a6c5906d-8f04-42f7-885f-e7490ec6b5bc
Route
ORAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (2 [hp_X])
Inactive Ingredients
Corn Syrup Glycine Sucrose Cherry

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-07-20

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

Indications and Usage

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
Dosage and Administration

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
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)

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 51727-6

Inactive ingredients

corn syrup, glycine, natural flavors, sucrose

Section 53413-1

Questions?

1-800-327-2704 m-F 8am-5pm EST

Section 53414-9

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

Section 55105-1

Purpose

Cold remedy

Section 55106-9

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 60561-8

Other information

  • store in a cool, dry place after opening
  • best if used within 6 months after opening
Principal Display Panel

Cold-EEZE®

Cold Remedy Lozenge

Zinc Gluconate Homeeopathic

NATURAL CHERRY FLAVOR

Formulated to reduce the duration of the common cold when taken at the first sign of symptoms.

20 Lozenges per box


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
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 51727-6 (51727-6)

Inactive ingredients

corn syrup, glycine, natural flavors, sucrose

Section 53413-1 (53413-1)

Questions?

1-800-327-2704 m-F 8am-5pm EST

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cold remedy

Section 55106-9 (55106-9)

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 60561-8 (60561-8)

Other information

  • store in a cool, dry place after opening
  • best if used within 6 months after opening
Principal Display Panel

Cold-EEZE®

Cold Remedy Lozenge

Zinc Gluconate Homeeopathic

NATURAL CHERRY FLAVOR

Formulated to reduce the duration of the common cold when taken at the first sign of symptoms.

20 Lozenges per box


Advanced Ingredient Data


Raw Label Data

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