ULTRA COLD REMEDY RAPIDMELTS- zinc acetate and zinc gluconate tablet 
Izeen Pharma, Inc.

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.

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Ultra Zinc Cold Remedy Fast Melting -Cherry Flavor

Drug Facts

Active ingredients (in each tablet)

Zincum aceticum 2x
Zincum gluconicum 1x

Purpose

Reduces duration and severity of the common cold

Uses

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

Other information

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

Manufactured by Izeen Pharma, Inc. 6900 English Muffin Way, Unit A, Frederick, MD 21703

PRINCIPAL DISPLAY PANEL - 18 Tablet Carton

NDC# 66007-103-18

Principal Display Panel-Carton

ULTRA COLD REMEDY RAPIDMELTS 
zinc acetate and zinc gluconate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66007-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 [hp_X]
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScoreno score
ShapeROUNDSize15mm
FlavorCHERRYImprint Code Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66007-103-181 in 1 CARTON
118 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/06/2015
Labeler - Izeen Pharma, Inc. (079300974)
Establishment
NameAddressID/FEIBusiness Operations
Izeen Pharma, Inc.079300974MANUFACTURE(66007-103)

Revised: 2/2015
Document Id: a2f36978-5282-4e46-b79a-5a593bdf65c3
Set id: 9d81d3ef-bb1a-49ac-92e1-c3d278c4e3f4
Version: 1
Effective Time: 20150205
 
Izeen Pharma, Inc.