Zinc Cold Remedy Fast Melting (Zinc Acetate And Zinc Gluconate) Tablet [Izeen Pharma, Inc.] -

ZINC COLD REMEDY FAST MELTING (ZINC ACETATE AND ZINC GLUCONATE) TABLET [IZEEN PHARMA, INC.]
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NDC	66007-101-25
Set ID	d17f12ad-6d6c-4a80-a22c-9af2c8d95820
Category	HUMAN OTC DRUG LABEL
Packager	Izeen Pharma, Inc.
Generic Name
Product Class
Product Number
Application Number

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients (in each tablet)

Zincum aceticum 2x
Zincum gluconicum 1x
Purpose

Reduces duration and severity of the common cold
Uses
- may reduce duration of the common cold
- may reduce the severity of cold symptoms
  - stuffy nose
  - sneezing
  - coughing
  - nasal congestion
Warnings

Ask a doctor before use if you have

Warnings

Zinc Cold Remedy was formulated to shorten the duration of the common cold and is not forulated to be effective for the flu or allergies.

Ask your doctor or pharmacist if you are allergic or sensitive to zinc.

Stop use and ask a doctor if symptoms persist or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- for best results, use at the first sign of a cold and continue to use until symptoms completely subside
- adults and children 12 years of age and older:
  - take 1 tablet at the onset of symptoms
  - dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
  - repeat every 4-6 hours, not to exceed 4 tablets in 24 hours
  - to avoid minor stomach upset, do not take on an empty stomach
  - do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
- children under 12 years of age: ask a doctor before use
Other information
- store between 15-29° (59-84°F)
Inactive ingredients

acesulfame –K, crospovidone, magnisium streate, mannatol, microcrystalline celulose , polysorbate 80, modified food starch , soodium lauryl sulfate, sodium starch glycolate, sorbitan monostearate, sucralose, talc.
Questions/Comments

Questions/Comments call 1-844-287-0260
SPL UNCLASSIFIED SECTION

Manufactured by Izeen Pharma, Inc. 6900 English Muffin Way, Unit A, Frederick, MD 21703
PRINCIPAL DISPLAY PANEL-25-Carton

INGREDIENTS AND APPEARANCE

ZINC COLD REMEDY FAST MELTING
zinc acetate and zinc gluconate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66007-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2 [hp_X]
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	1 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SORBITAN (UNII: 6O92ICV9RU)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	15mm
Flavor	CHERRY	Imprint Code	CP115
Contains

#	Item Code	Package Description
Packaging
1	NDC:66007-101-25	1 in 1 CARTON
1		25 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved homeopathic		02/06/2015

Labeler - Izeen Pharma, Inc. (079300974)

Name	Address	ID/FEI	Business Operations
Establishment
Izeen Pharma, Inc.		079300974	MANUFACTURE(66007-101)

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Medic

ZINC COLD REMEDY FAST MELTING (ZINC ACETATE AND ZINC GLUCONATE) TABLET [IZEEN PHARMA, INC.]

Ask a doctor before use if you have

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