FDA Label for Cold Eeze

View Indications, Usage & Precautions

Cold Eeze Product Label

The following document was submitted to the FDA by the labeler of this product Jhk Inc Dba American Safety & First Aid. 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.

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Drug Facts


Active Ingredient (Per Lozenge)



Zinc Gluconate 2X HPUS (2.3%) (13.3mg Zinc)

The letters 'HPUS' indicate that the active ingredient is in the official Homeopathic Pharmacopoeia of the United States.


Purpose



Cold Remedy


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. The product is only intended 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 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 beyond 7 days.


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a health 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.


Directions



  • Take one lozenge at the onset of symptoms
  • Dissolve the entire lozenge in the 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 - 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

Inactive Ingredients



Corn syrup, glycine, natural flavors and sucrose


Questions?



1-800-505-2653 Mon.- Fri. 8:00am-5:00pm EST


Principal Display Panel - 25 Lozenge Box



Product# 1242

Cold-EEZE®

ZINC GLUCONATE HOMEOPATHIC

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