Label: COLD-EEZE NATURAL MULTI-SYMPTOM RELIEF- zinc gluconate, sambucus nigra flower, eupatorium perfoliatum flowering top, mentha piperita, myrrh, and glycyrrhiza glabra leaf tablet, orally disintegrating
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Contains inactivated NDC Code(s)
NDC Code(s): 61941-0226-1, 61941-0226-4, 61941-0226-5, 61941-0226-6 - Packager: ProPhase Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 November 24, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredient (per tablet) Purpose Zincum Gluconicum 1X Cold Remedy Sambucus nigra 1X
Eupatorium perfoliatum 1XFor temporary relief of flu symptoms (cough, nasal and chest congestion and irritated respiratory tract) Mentha Piperita 2X For temporary relief of cough Myrrha 2X For temporary relief of Sore Throat Glycyrrhiza G. L. (Licorice Root) 3X For temporary relief of Irritated Throat - Uses
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Warnings
Ask a doctor before use if you
- are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines
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Directions
- Take Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu QuickMelts® when you have cold or flu symptoms
- Adults:
- Dissolve entire tablet in mouth. Do not chew. Do not swallow whole
- Take 1 tablet at the onset of symptoms
- Repeat every 2-4 hours as needed until all symptoms subside
- Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids
- Recommended daily dose is 6 tablets for adults and 4 tablets for ages 12-17 years
- For children under 12 years of age, consult a healthcare practitioner before use
- Other information
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Inactive ingredients
beta carotene, crospovidone, glycine, magnesium stearate, malic acid, maltodextrin, mannitol, microcrystalline cellulose, natural honey crystals, natural honey lemon flavor, natural menthol flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stevia, sucralose, talc.
- Questions or Comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton
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INGREDIENTS AND APPEARANCE
COLD-EEZE NATURAL MULTI-SYMPTOM RELIEF
zinc gluconate, sambucus nigra flower, eupatorium perfoliatum flowering top, mentha piperita, myrrh, and glycyrrhiza glabra leaf tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-0226 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Gluconate (UNII: U6WSN5SQ1Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Gluconate 1 [hp_X] Sambucus Nigra Flower (UNII: 07V4DX094T) (Sambucus Nigra Flower - UNII:07V4DX094T) Sambucus Nigra Flower 1 [hp_X] Eupatorium Perfoliatum Flowering Top (UNII: 1W0775VX6E) (Eupatorium Perfoliatum Flowering Top - UNII:1W0775VX6E) Eupatorium Perfoliatum Flowering Top 1 [hp_X] Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9) Mentha Piperita 2 [hp_X] Myrrh (UNII: JC71GJ1F3L) (Myrrh - UNII:JC71GJ1F3L) Myrrh 2 [hp_X] Glycyrrhiza Glabra Leaf (UNII: GH32M797Y9) (Glycyrrhiza Glabra Leaf - UNII:GH32M797Y9) Glycyrrhiza Glabra Leaf 3 [hp_X] Inactive Ingredients Ingredient Name Strength Glycine (UNII: TE7660XO1C) .Beta.-Carotene (UNII: 01YAE03M7J) Crospovidone (UNII: 68401960MK) MAGNESIUM STEARATE (UNII: 70097M6I30) MALIC ACID (UNII: 817L1N4CKP) MALTODEXTRIN (UNII: 7CVR7L4A2D) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Honey (UNII: Y9H1V576FH) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color YELLOW Score no score Shape OCTAGON (8 SIDED) Size 15mm Flavor LEMON (Honey Lemon) Imprint Code ZM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61941-0226-5 36 in 1 CASE 1 NDC:61941-0226-4 4 in 1 BOX 1 NDC:61941-0226-1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:61941-0226-6 48 in 1 CASE 2 NDC:61941-0226-4 4 in 1 BOX 2 NDC:61941-0226-1 6 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 12/01/2014 Labeler - ProPhase Labs, Inc. (620557298) Establishment Name Address ID/FEI Business Operations ProPhase Labs, Inc. 620557298 LABEL(61941-0226) , ANALYSIS(61941-0226) , REPACK(61941-0226) Establishment Name Address ID/FEI Business Operations Pharmaloz Manufacturing, Inc. 067101998 MANUFACTURE(61941-0226) , PACK(61941-0226) , REPACK(61941-0226)
