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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62750-055
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 (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
Color	PINK	Score	no score
Shape	ROUND	Size	15mm
Flavor	CHERRY	Imprint Code	Z
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62750-055-10	1 in 1 CARTON	02/14/2013	06/30/2019
1		18 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved homeopathic		02/14/2013	06/30/2019

Labeler - Matrixx Initiatives, Inc. (790037253)

Name	Address	ID/FEI	Business Operations
Establishment
Nutritional Labs International		007306970	MANUFACTURE(62750-055)

Name	Address	ID/FEI	Business Operations
Establishment
Nutritional Labs International		607917999	REPACK(62750-055)

Revised: 6/2019

Document Id: 855390af-1ccb-47b0-a960-f6cdd44873b0

Set id: 98c39bdd-9da9-4f64-a310-8b6728fc4517

Version: 4

Effective Time: 20190620

Matrixx Initiatives, Inc.