Label: COLD-EEZE COLD REMEDY- zinc gluconate, sambucus nigra, glycyrrhiza glabra lozenge
- NDC Code(s): 71179-343-25
- Packager: Vespyr Brands 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 May 9, 2023
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- Drug Facts
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Active ingredients
Active ingredients (per lozenge ) . . . . . . . . . . . . . . . . . . . . . . Purposes
Zinc Gluconate 2X HPUS† (2.22%) (13.3 mg zinc).................... Cold Remedy
Sambucus Nigra 2X HPUS† (1.0%) ........................................... Relieves cough, nasal congestion and irritated respiratory tract*
Glycyrrhiza Glabra (Licorice) 3X HPUS† (0.1%)......................... Relieves irritated throat*
† The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States. - Purposes
- Uses
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Warnings
Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and provide relief of cold and flu symptoms.
Ask a doctor before use if you have
• diabetes • multiple sclerosis (MS) • rheumatoid arthritis (RA) or other auto-immune condition -
Directions
• take one lozenge at the onset of symptoms • do not chew
• dissolve entire lozenge in mouth • do not swallow whole
• do not eat or drink for 15 minutes after use
• repeat every 2-4 hours until symptoms subsideAdults 18 years and over do not exceed 6 lozenges per day Children 12 to under 18 years do not exceed 4 lozenges per day Children under 12 years ask a doctor before use - Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL
Cold-EEZE ®
COLD REMEDY
HOMEOPATHIC
Plus COLD & FLU SYMPTOM RELIEF*
HELPS RELIEVE Cough, Congestion, Sore Throat*
NATURAL MIXED BERRY FLAVOR
25 Lozenges
©2022 Vespyr Brands ®, Inc.
Cold-EEZE ® is a registred trademark of Vespyr Brands ®, Inc.
Distributed by Vespyr Brands®, Inc.
East Windsor, NJ 08520
This product has not been evaluated by the FDA
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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INGREDIENTS AND APPEARANCE
COLD-EEZE COLD REMEDY
zinc gluconate, sambucus nigra, glycyrrhiza glabra lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71179-343 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 13.3 mg SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER 45 mg GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA 4.5 mg Inactive Ingredients Ingredient Name Strength GLYCINE (UNII: TE7660XO1C) SUCROSE (UNII: C151H8M554) CORN SYRUP (UNII: 9G5L16BK6N) Product Characteristics Color purple Score score with uneven pieces Shape OVAL Size 23mm Flavor BERRY (mixed) Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71179-343-25 25 in 1 BOX 01/02/2023 1 1 in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/21/2022 Labeler - Vespyr Brands Inc (118094893)