ZICAM COLD REMEDY ORAL MIST- zinc acetate and zinc gluconate spray

Zicam Cold Remedy Oral Mist by

Drug Labeling and Warnings

Zicam Cold Remedy Oral Mist by is a Homeopathic medication manufactured, distributed, or labeled by Matrixx Initiatives, Inc., Accupac, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients

Zincum aceticum 2x
Zincum gluconicum 1x

Purpose

Reduces duration and severity of the common cold

Uses

• reduces duration of the common cold
• helps reduce severity of cold symptoms:
  • sore throat
  • stuffy nose
  • sneezing
  • coughing
  • nasal congestion

Zicam® Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

Warnings

For oral use only

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc

When using this product avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.

Stop use and ask a doctor if symptoms, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition.

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:
  • spray 4 times in mouth at the onset of symptoms. Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
  • repeat every 2- 3 hours, not to exceed 7 doses in 24 hours. Take 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

benzalkonium chloride, glycerin, menthol, natural & artificial flavor, PEG-40 hydrogenated castor oil, purified water, sucralose, xylitol

Questions? Comments? Side Effects?

call 877-942-2626 toll free

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Distributed by Matrixx Initiatives, Inc.
Scottsdale, Arizona 85260.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC: 62750-060-10

ZICAM®
COLD REMEDY

SHORTENS COLDS

+ SOOTHES SORE THROATS
AND COUGHS

TAKE AT THE FIRST
SIGN OF A COLD

THE
PRE-COLD®
MEDICINE

SEE
WHAT'S
INSIDE!

CLINICALLY PROVEN TO SHORTEN COLDS

ORAL MIST™

GREAT TASTING

Arctic Mint Flavor

1.0 FL OZ
(30 mL)

HOMEOPATHIC

INGREDIENTS AND APPEARANCE

ZICAM COLD REMEDY ORAL MIST 
zinc acetate and zinc gluconate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62750-060
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]  in 1 mL
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	1 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62750-060-10	1 in 1 CARTON	03/01/2013
1		30 mL 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		03/01/2013

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc		071609663	MANUFACTURE(62750-060)