Cold-eeze
FDA Label NDC 61941-0229

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prophase Labs, Inc. for the product Cold-eeze (NDC 61941-0229). 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 other, active ingredient (per caplet), purpose, uses, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Cold-EEZE® Natural Allergy Relief is formulated to help you with temporary relief of symptoms associated with indoor/outdoor and seasonal allergies

Distributed by:
ProPhase Labs, Inc.
P.O. Box 1349, Doylestown
PA 18901

Active Ingredient (Per Caplet)

Allium Cepa L 2X
Eupatorium perfoliatum 1X
Polygonum fagopyrum L. 2X
Pothos Foetidus 2X
Sambucus nigra 1X
Tussilago petasites L.1X
Urtuca dioica 1X
Zincum Gluconicum 2X

Purpose

For temporary relief of symptoms associated with allergies

Uses

For temporary relief of symptoms associated with allergies: Breathing difficulties, headache, congestion, itchy eyes, runny nose, stuffy nose and bronchial spasms

Otc - Ask Doctor

Ask a doctor before use if you

  • Are on anticoagulant therapy, barbiturates, or are under medical supervision for diabetes and are taking diabetes medication, as sambucus nigra (Elder Flower) can decrease blood sugar levels

Otc - Stop Use

Stop use and ask your healthcare practitioner if you have noticed any allergic reaction or rashes or if symptoms persist beyond 5 days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a healthcare practitioner before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Take Cold-EEZE® Natural Allergy Symptom Relief when you have allergy symptoms
  • For ages 12 years and older:
    • Take 1 caplet with water
    • Repeat every 8-12 hours as needed until all symptoms subside
    • Do Not Take more than 3 caplets per day
    • Recommended daily dose is 2 caplets per day
    • For individuals under the age of 12, consult a healthcare practitioner before use

Other Information

  • Do not crush or divide the Cold-EEZE® Natural Allergy Symptom Relief caplets
  • Store in a dark, cool and dry place

Inactive Ingredients

Carbopol, dibasic calcium phosphate, magnesium stearate, methocel, microcrystalline cellulose, silicon dioxide, stearic acid.

Questions Or Comments

Call 1-800-505-2653 (M-F: 9AM-5PM EST) www.ColdEEZE.com

Principal Display Panel - 20 Caplet Blister Pack Box

NEW

From the makers of
Cold-EEZE®

NATURAL
ALLERGY
RELIEF™

Up to 12 Hours Extended-Release

For Relief of:

  • ☑Congestion
  • ☑Itchy Eyes
  • ☑Runny Nose
    & Stuffy Nose

    • Non
    Drowsy

    20
    Coated
    Caplets

    Homeopathic

    Actual size

    For Indoor
    & Outdoor
    Allergies

    Principal Display Panel (20 Caplet Blister Pack Box)

    Principal Display Panel (20 Caplet Blister Pack Box)

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