FDA Label for Cold-eeze Daytime And Nighttime Quickmelts
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (PER TABLET)
- PURPOSE
- USES
- ASK A DOCTOR BEFORE USE IF YOU
- OTC - STOP USE
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTC - PURPOSE
- ASK A DOCTOR BEFORE USING COLD-EEZE®
- OTC - DO NOT USE
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL - KIT CARTON
Cold-eeze Daytime And Nighttime Quickmelts Product Label
The following document was submitted to the FDA by the labeler of this product Prophase Labs, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Cold-EEZE® Daytime QuickMelts® (AM)
Drug Facts
Cold-EEZE® Nighttime QuickMelts® (PM)
Drug Facts
Manufactured for and
Distributed by:
ProPhase Labs, Inc.
P.O. Box 1349, Doylestown
PA 18901
Active Ingredient (Per Tablet)
Zincum Gluconicum 1X
Purpose
Cold Remedy
Uses
Take 1 QuickMelt every 2-4 hours per Directions on inside panel.
- to reduce the duration of the common cold.
- reduces the severity of cold symptoms: cough, sore throat, nasal congestion post nasal drip and/or hoarseness.
- to reduce the duration of the common cold.
- reduces the severity of cold symptoms: cough, sore throat, nasal congestion post nasal drip and/or hoarseness.
- helps to relax and sleep easier to get rested.
Take 1 Nighttime QuickMelt 1 hour before bedtime per Directions on inside panel.
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.
Otc - Stop Use
Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.
Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.
Otc - When Using
Cold-EEZE® QuickMelts® Daytime is formulated to reduce the duration of the common cold and its symptoms and is insufficient treatment for Influenza or Allergies.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a healthcare practitioner before use.
If pregnant or breast feeding, ask a healthcare practitioner before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Keep out of reach of children.
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.
- 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
- Do not take Cold-EEZE® QuickMelts® on an empty stomach to avoid possible minor stomach upset.
- Store in a cool and dry place.
- Do not take Cold-EEZE® QuickMelts® on an empty stomach to avoid possible minor stomach upset.
- Store in a cool and dry place.
Inactive Ingredients
crospovidone, FD&C Red # 40, glycine, magnesium stearate, malic acid, mannitol, microcrystalline cellulose, natural mixed berry flavor, natural menthol flavor, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stevia, sucralose, talc.
crospovidone, FD&C Blue #1 & #2, glycine, magnesium stearate, malic acid, maltodextrin, mannitol, microcrystalline cellulose, natural mixed berry flavor, natural menthol flavor, polyethylene glycol, sodium lauryl sulfate, silicon dioxide, sodium starch glycolate, stevia, sucralose, talc.
Otc - Purpose
| Active ingredients (per tablet) | Purpose |
| Zincum Gluconicum 1X | Cold Remedy |
| Valeriana Officinalis 1X | Sleep Disorder Remedy |
| Chamomile (Matricaria recutita) 2X | Relaxation and Calming |
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.
Otc - Do Not Use
Do not take Cold-EEZE® Nighttime QuickMelts® while operating a motor vehicle or machinery or consuming alcohol.
Allow 6-8 hours for sleep after taking tablet.
Questions Or Comments
Call 1-800-505-2653 (M-F: 9AM-5PM EST)
Principal Display Panel - Kit Carton
NEW QuickMelts®
GREAT
TASTE
Cold-EEZE®
Zinc Gluconate Glycine
COLD REMEDY
CLINICALLY PROVEN
INGREDIENT
Daytime
Nighttime
#1 Pharmacist Recommended
Daytime
﹢ Shortens your cold,
works faster™﹢ Non-drowsy﹢ Shortens your cold,
works faster™﹢ Fall asleep faster,
naturally﹢ Non-habit forming
Nighttime
18 MELTS
(Daytime)
QuickMelts®
Natural
Mixed Berry Flavor
Homeopathic
6 MELTS
(Nighttime)
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