Label: COLD-EEZE GUMMIES PLUS MULTI-SYMPTOM RELIEF COLD AND FLU- zinc gluconate, mentha piperita, eupatorium perfoliatum flowering top, sambucus nigra flower, myrrh, and glycyrrhiza glabra leaf tablet, orally disintegrating
- 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.
Updated October 11, 2016
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
Active Ingredients (2 gummies) Purpose Zincum Gluconicum 1X Cold Remedy Mentha piperita 1X For temporary relief of cough Sambucus nigra 2X For temporary relief of flu symptoms Eupatorium perfoliatum 2X (cough, congestion and irritated respiratory tract) Myrrha 2X For temporary relief of Sore Throat Glycyrrhiza G. L. (Licorice Root) 2X For temporary relief of Irritated Throat
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
Stop use and ask your healthcare practitioner if symptoms persist for more than 7 days or are accompanied by fever, rash or persistent headache
Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu gummies is a combination product formulated to help you to reduce the duration of the common cold and to help for temporary relief of Cold and Flu symptoms. It is insufficient treatment for Influenza or Allergies.
Sore Throat Warning
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.
- Take Cold-EEZE® Plus Multi-Symptom Relief Cold & Flu gummies when you have cold or flu symptoms
- Dissolve 2 gummies in mouth. Do not swallow whole. For best results, dissolve in your mouth.
- Take 2 gummies 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 12 gummies for adults and 8 gummies for ages 12-17 years
- For children under 12 years of age, consult a healthcare practitioner before use
- Other information
- Inactive ingredients
- Questions or Comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 36 gummy Bottle Label
INGREDIENTS AND APPEARANCE
COLD-EEZE GUMMIES PLUS MULTI-SYMPTOM RELIEF COLD AND FLU
zinc gluconate, mentha piperita, eupatorium perfoliatum flowering top, sambucus nigra flower, myrrh, and glycyrrhiza glabra leaf tablet, orally disintegrating
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-0234 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] Mentha Piperita (UNII: 79M2M2UDA9) (Mentha Piperita - UNII:79M2M2UDA9) Mentha Piperita 1 [hp_X] eupatorium perfoliatum flowering top (UNII: 1W0775VX6E) (eupatorium perfoliatum flowering top - UNII:1W0775VX6E) eupatorium perfoliatum flowering top 2 [hp_X] sambucus nigra flower (UNII: 07V4DX094T) (sambucus nigra flower - UNII:07V4DX094T) sambucus nigra flower 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 2 [hp_X] Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate (UNII: 2968PHW8QP) Corn Syrup (UNII: 9G5L16BK6N) Gelatin, Unspecified (UNII: 2G86QN327L) Glycine (UNII: TE7660XO1C) MALTODEXTRIN (UNII: 7CVR7L4A2D) Pectin (UNII: 89NA02M4RX) SUCROSE (UNII: C151H8M554) Product Characteristics Color PURPLE Score no score Shape OVAL Size 15mm Flavor BERRY (Mixed Berry) Imprint Code Smiley;Face Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61941-0234-0 36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 10/01/2016 Labeler - ProPhase Labs, Inc. (620557298) Establishment Name Address ID/FEI Business Operations ProPhase Labs, Inc. 620557298 LABEL(61941-0234) Establishment Name Address ID/FEI Business Operations Pharmaloz Manufacturing, Inc. 067101998 PACK(61941-0234) , ANALYSIS(61941-0234) , REPACK(61941-0234) , MANUFACTURE(61941-0234)