Label: COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS- zinc gluconate, valerian, and chamomile kit
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Contains inactivated NDC Code(s)
NDC Code(s): 61941-0225-4 - 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 25, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (per tablet)
- Purpose
- 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® Daytime QuickMelts® when you have cold symptoms
- Adults and Children 12 years and over:
- 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.
- Dissolve entire tablet in mouth. Do not chew.
- For children under 12 years of age, consult a healthcare practitioner before use.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
Ask a doctor before using Cold-EEZE®
Nighttime QuickMelts® if you
- are taking fluvoxamine (Luvox), minocycline, doxycycline, tetracycline or are on Coumadin therapy, as zinc treatment may inhibit the absorption of these medicines.
- are under medical supervision and/or are taking tranquilizers, sedatives or anti-seizure medicines.
- do not take concomitantly with loperamide.
Cold-EEZE® Nighttime QuickMelts® is a combination product formulated to help you to sleep easier and to reduce the duration of the common cold and its symptoms and is insufficient treatment for Influenza or Allergies.
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Directions
- Take Cold-EEZE® Nighttime QuickMelts® at night when you have cold symptoms.
- Adults;
- Dissolve entire tablet in mouth. Do not chew.
Do not swallow whole. - Take 1 Nighttime tablet 1 hour before bedtime.
- Do not eat or drink for 15 minutes after use, otherwise, drink plenty of fluids.
- Dissolve entire tablet in mouth. Do not chew.
- Recommended dose is 1 tablet for adults.
- For individuals under the age of 18, consult a healthcare practitioner before use.
- Other information
- Inactive ingredients
- Questions or Comments
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - Kit Carton
NEW QuickMelts®
GREAT
TASTECold-EEZE®
Zinc Gluconate Glycine
COLD REMEDYCLINICALLY PROVEN
INGREDIENTDaytime
Nighttime
#1 Pharmacist RecommendedDaytime
- ﹢
- Shortens your cold,
works faster™ - ﹢
- Non-drowsy
Nighttime
- ﹢
- Shortens your cold,
works faster™ - ﹢
- Fall asleep faster,
naturally - ﹢
- Non-habit forming
18 MELTS
(Daytime)QuickMelts®
Natural
Mixed Berry Flavor
Homeopathic6 MELTS
(Nighttime) -
INGREDIENTS AND APPEARANCE
COLD-EEZE DAYTIME AND NIGHTTIME QUICKMELTS
zinc gluconate, valerian, and chamomile kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61941-0225 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61941-0225-4 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 18 Part 2 1 BLISTER PACK 6 Part 1 of 2 COLD-EEZE DAYTIME QUICKMELTS
zinc gluconate tablet, orally disintegratingProduct Information 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] Inactive Ingredients Ingredient Name Strength Glycine (UNII: TE7660XO1C) MALIC ACID (UNII: 817L1N4CKP) Crospovidone (UNII: 68401960MK) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color PINK Score no score Shape OCTAGON (8 sided) Size 15mm Flavor BERRY (MIXED BERRY) Imprint Code AM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 18 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 Part 2 of 2 COLD-EEZE NIGHTTIME QUICKMELTS
zinc gluconate, valerian, and chamomile tablet, orally disintegratingProduct Information 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] VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 1 [hp_X] Chamomile (UNII: FGL3685T2X) (Chamomile - UNII:FGL3685T2X) Chamomile 2 [hp_X] Inactive Ingredients Ingredient Name Strength Glycine (UNII: TE7660XO1C) MALIC ACID (UNII: 817L1N4CKP) Crospovidone (UNII: 68401960MK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color BLUE Score no score Shape OCTAGON (8 sided) Size 15mm Flavor BERRY (MIXED BERRY) Imprint Code PM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 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(61941-0225) , ANALYSIS(61941-0225) , REPACK(61941-0225) Establishment Name Address ID/FEI Business Operations Pharmaloz Manufacturing, Inc. 067101998 MANUFACTURE(61941-0225) , PACK(61941-0225) , REPACK(61941-0225)