First Aid Direct Cold-eeze Cold Remedy Lozenge
FDA Label NDC 42961-105

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corporation for the product First Aid Direct Cold-eeze Cold Remedy (NDC 42961-105). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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.

Otc - Purpose

Purpose

Cold remedy

Indications & 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

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

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. 

Otc - When Using

When using this product do not take on an empty stomach (to avoid possible minor stomach upset)

Otc - Stop Use

Stop use and ask your doctor if symptoms persist more than 7 days

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 

Dosage & 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

Other Safety Information

Other information

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

Inactive Ingredient

Inactive ingredients

corn syrup, glycine, natural flavors, sucrose

Otc - Questions

Questions?

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

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

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

1192000

Box_label (Box Label)

Box_label (Box Label)

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