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

ULTRA COLD REMEDY RAPIDMELTS (ZINC ACETATE AND ZINC GLUCONATE) TABLET [IZEEN PHARMA, INC.]
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NDC	66007-103-18
Set ID	9d81d3ef-bb1a-49ac-92e1-c3d278c4e3f4
Category	HUMAN OTC DRUG LABEL
Packager	Izeen Pharma, Inc.
Generic Name
Product Class
Product Number
Application Number

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Drug Facts
Active ingredients (in each tablet)

Zincum aceticum 2x
Zincum gluconicum 1x
Purpose

Reduces duration and severity of the common cold
Uses
- reduces duration of the common cold
- reduces the severity of cold symptoms:
  - sore throat
  - stuffy nose
  - sneezing
  - coughing
  - nasal congestion
Zicam® ULTRA Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.
Warnings
Ask a doctor before use if you have
- a sensitivity to zinc or are allergic 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

artificial flavor, crospovidone, FD&C red no. 40 aluminum lake, magnesium stearate, mannitol, monoammonium glycyrrhizinate, sodium starch glycolate, stearic acid, sucralose
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 - 18 Tablet Carton

NDC# 66007-103-18

INGREDIENTS AND APPEARANCE

ULTRA COLD REMEDY RAPIDMELTS
zinc acetate and zinc gluconate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66007-103
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
CROSPOVIDONE (UNII: 68401960MK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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

#	Item Code	Package Description
Packaging
1	NDC:66007-103-18	1 in 1 CARTON
1		18 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(66007-103)

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Medic

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

Ask a doctor before use if you have

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