{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 56 } }, "results": [ { "spl_product_data_elements": [ "Cold-EEZE Cold Remedy Zinc Gluconate, Sambucus Nigra, Avena Sativa L., Rosa Canina, Echinacea Purpurea AVENA SATIVA FLOWERING TOP AVENA SATIVA FLOWERING TOP SAMBUCUS NIGRA FLOWER SAMBUCUS NIGRA FLOWER ECHINACEA PURPUREA ECHINACEA PURPUREA ROSA CANINA FRUIT ROSA CANINA FRUIT ZINC GLUCONATE ZINC CATION GLYCINE SUCROSE CORN SYRUP P with Elderberry" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients Active ingredients (per lozenge ) . . . . . . . . . . . . . . . . . . . . . . Purposes Zinc Gluconate 1X HPUS † (2.22%) (13.3 mg zinc).................. Cold Remedy Sambucus Nigra 1X HPUS † (1.11%) ......................................... Promotes immune support* Avena Sativa L. 2X HPUS † (0.14%) ............................................ Helps with general debility and fatigue* Rosa Canina (Rose Hips) 2X HPUS † (0.09%) ........................ Promotes immune support* Echinacea Purpurea 3X HPUS † (0.04%) .................................. Promotes immune support* † The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States." ], "purpose": [ "Purposes Purposes" ], "indications_and_usage": [ "Uses reduces the duration of the common cold reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness supports immune system health* helps with general debility and fatigue*" ], "warnings": [ "Warnings Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms. Ask a doctor before use if you have • diabetes • multiple sclerosis (MS) • rheumatoid arthritis (RA) or other auto-immune condition Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines. When using this product do not take on an empty stomach (to avoid possible minor stomach upset) Stop use and ask your doctor if symptoms persist more than 7 days If pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms." ], "ask_doctor": [ "Ask a doctor before use if you have • diabetes • multiple sclerosis (MS) • rheumatoid arthritis (RA) or other auto-immune condition" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines." ], "when_using": [ "When using this product do not take on an empty stomach (to avoid possible minor stomach upset)" ], "stop_use": [ "Stop use and ask your doctor if symptoms persist more than 7 days" ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding , ask a healthcare professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "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 subside Adults 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" ], "dosage_and_administration_table": [ "
Adults 18 years and overdo not exceed 6 lozenges per day
Children 12 to under 18 yearsdo not exceed 4 lozenges per day
Children under 12 yearsask a doctor before use
" ], "storage_and_handling": [ "Other information store in a cool, dry place after opening best if used within 6 months after opening" ], "inactive_ingredient": [ "Inactive ingredients corn syrup, glycine, natural colors, natural flavors, sucrose" ], "questions": [ "Questions or comments? call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)" ], "package_label_principal_display_panel": [ "Cold-EEZE ® COLD REMEDY HOMEOPATHIC Plus DEFENSE* PROMOTES Immune Health* HELPS with Fatigue* NATURAL FLAVOR CITRUS with ELDERBERRY 12 Lozenges ©2023 Vespyr Brands ® , Inc. All rights reserved 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. label" ], "set_id": "02f6a97c-017c-234e-e063-6394a90afa37", "id": "514348b4-f851-7512-e063-6294a90a1e9d", "effective_time": "20260501", "version": "3", "openfda": { "brand_name": [ "Cold-EEZE Cold Remedy" ], "generic_name": [ "ZINC GLUCONATE, SAMBUCUS NIGRA, AVENA SATIVA L., ROSA CANINA, ECHINACEA PURPUREA" ], "manufacturer_name": [ "Vespyr Brands LLC" ], "product_ndc": [ "71179-323" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AVENA SATIVA FLOWERING TOP", "ECHINACEA PURPUREA", "ROSA CANINA FRUIT", "SAMBUCUS NIGRA FLOWER", "ZINC GLUCONATE" ], "spl_id": [ "514348b4-f851-7512-e063-6294a90a1e9d" ], "spl_set_id": [ "02f6a97c-017c-234e-e063-6394a90afa37" ], "package_ndc": [ "71179-323-25", "71179-323-12" ], "is_original_packager": [ true ], "unii": [ "MA9CQJ3F7F", "QI7G114Y98", "3TNW8D08V3", "07V4DX094T", "U6WSN5SQ1Z" ] } } ] }