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 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 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°C (59-84°F)

Inactive ingredients

crospovidone, FD&C yellow no. 6 aluminum lake, magnesium stearate, mannitol, monoammonium glycyrrhizinate, natural and artificial flavor, 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®

Orange Cream Flavor

18
Quick Dissolve
TABLETS

HOMEOPATHIC

ZICAM COLD REMEDY ULTRA RAPIDMELTS 
zinc acetate and zinc gluconate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62750-056
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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]

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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	ORANGE	Score	no score
Shape	ROUND	Size	15mm
Flavor	ORANGE	Imprint Code	Z
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62750-056-10	1 in 1 CARTON	02/14/2013	06/15/2019
1		18 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		02/14/2013	06/15/2019

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment
Name	Address	ID/FEI	Business Operations
Nutritional Labs International		007306970	MANUFACTURE(62750-056)

Establishment
Name	Address	ID/FEI	Business Operations
Nutritional Labs International		607917999	REPACK(62750-056)

Revised: 6/2019

Document Id: 1fca5891-f057-4bf5-8eee-4e422436c8d8

34390-5

Set id: 8faab556-f1a7-4814-816e-b5b1937f5a0a

Version: 5

Effective Time: 20190603

 

Matrixx Initiatives, Inc.