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  5. Label Information: First Aid Direct Cold-eeze Cold Remedy

FDA Label for First Aid Direct Cold-eeze Cold Remedy

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR/PHARMACIST
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. PRINCIPAL DISPLAY PANEL

First Aid Direct Cold-eeze Cold Remedy Product Label

The following document was submitted to the FDA by the labeler of this product Cintas Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.