Zicam® Cold Remedy Ultra Rapidmelts®

Zicam Cold Remedy Ultra Rapidmelts by

Drug Labeling and Warnings

Zicam Cold Remedy Ultra Rapidmelts by is a Homeopathic medication manufactured, distributed, or labeled by Matrixx Initiatives, Inc., Nutritional Labs International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZICAM COLD REMEDY ULTRA RAPIDMELTS- zinc acetate and zinc gluconate tablet 
Matrixx Initiatives, 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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Zicam® Cold Remedy Ultra Rapidmelts®

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 a fever or new symptoms occur

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 3 hours until symptoms are gone
    • 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? Side Effects?

call 877-942-2626 toll free
www.zicam.com

Distributed by Matrixx Initiatives, Inc.
Scottsdale, Arizona 85255.

PRINCIPAL DISPLAY PANEL - 18 Tablet Bottle Carton

#1 COLD SHORTENING BRAND*

GREAT
TASTING!

RAPIDMELTS®

Cherry Flavor

18
Quick Dissolve
TABLETS

HOMEOPATHIC

Principal Display Panel - 18 Tablet Bottle Carton
ZICAM COLD REMEDY ULTRA RAPIDMELTS 
zinc acetate and zinc gluconate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62750-055
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 (15 MPA.S AT 5%) (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: 62750-055-101 in 1 CARTON02/14/201306/30/2019
118 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic02/14/201306/30/2019
Labeler - Matrixx Initiatives, Inc. (790037253)
Establishment
NameAddressID/FEIBusiness Operations
Nutritional Labs International007306970MANUFACTURE(62750-055)
Establishment
NameAddressID/FEIBusiness Operations
Nutritional Labs International607917999REPACK(62750-055)

Revised: 6/2019