Label: COLD-EEZE NATURAL ALLERGY RELIEF- onion, eupatorium perfoliatum flowering top, buckwheat, symplocarpus foetidus root, sambucus nigra flower, tussilago farfara leaf, urtica dioica, and zinc gluconate tablet, delayed release
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Contains inactivated NDC Code(s)
NDC Code(s): 61941-0229-1, 61941-0229-4 - Packager: ProPhase Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 28, 2016
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient (per caplet)
- Purpose
- Uses
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Warnings
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
Stop use and ask your healthcare practitioner if you have noticed any allergic reaction or rashes or if symptoms persist beyond 5 days.
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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
- Inactive ingredients
- Questions or Comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Box
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INGREDIENTS AND APPEARANCE
COLD-EEZE NATURAL ALLERGY RELIEF
onion, eupatorium perfoliatum flowering top, buckwheat, symplocarpus foetidus root, sambucus nigra flower, tussilago farfara leaf, urtica dioica, and zinc gluconate tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-0229 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H) Onion 2 [hp_X] Eupatorium Perfoliatum Flowering Top (UNII: 1W0775VX6E) (Eupatorium Perfoliatum Flowering Top - UNII:1W0775VX6E) Eupatorium Perfoliatum Flowering Top 1 [hp_X] Buckwheat (UNII: N0Y68724R3) (Buckwheat - UNII:N0Y68724R3) Buckwheat 2 [hp_X] Symplocarpus Foetidus Root (UNII: R88254608W) (Symplocarpus Foetidus Root - UNII:R88254608W) Symplocarpus Foetidus Root 2 [hp_X] Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T) Sambucus Nigra Flower 1 [hp_X] Tussilago Farfara Leaf (UNII: G2GH7V846Z) (Tussilago Farfara Leaf - UNII:G2GH7V846Z) Tussilago Farfara Leaf 1 [hp_X] Urtica Dioica (UNII: 710FLW4U46) (Urtica Dioica - UNII:710FLW4U46) Urtica Dioica 1 [hp_X] Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Gluconate 2 [hp_X] Inactive Ingredients Ingredient Name Strength Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E) Calcium Phosphate, Dibasic, Dihydrate (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) Methylcellulose (25 MPA.S) (UNII: BI55GG2WLI) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Stearic Acid (UNII: 4ELV7Z65AP) Product Characteristics Color GRAY Score no score Shape OVAL Size 2mm Flavor Imprint Code ZA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61941-0229-4 2 in 1 BOX 1 NDC:61941-0229-1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 01/01/2016 Labeler - ProPhase Labs, Inc. (620557298) Establishment Name Address ID/FEI Business Operations ProPhase Labs, Inc. 620557298 LABEL(61941-0229) , ANALYSIS(61941-0229) , REPACK(61941-0229) Establishment Name Address ID/FEI Business Operations Pharmaloz Manufacturing, Inc. 067101998 MANUFACTURE(61941-0229) , PACK(61941-0229) , REPACK(61941-0229)