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Zicam

Matrixx Initiatives, Inc.

ZICAM


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 0.25 mL spray)

Dextromethorphan HBr 6.0 mg

Purpose

Cough Suppressant

Zicam Uses

temporarily relieves cough due to minor throat and bronchial irritation associated with a cold.

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • cough accompanied by excessive phlegm (mucus).
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs 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

  • Remove safety cap.
  • Prime pump by spraying into a tissue.
  • Hold close to mouth and depress sprayer fully. Swallow.
    12 yrs & older................5 sprays (30.0 mg Dextromethorphan HBr) Children under 12 years of age: DO NOT USE
  • Repeat every 6-8 hours, not to exceed 4 doses per day.
  • May be followed by water or liquids if desired.

Inactive ingredients

citric acid, glycerin, hydroxylated lecithin, menthol, natural flavors, polyethylene glycol, polysorbate 60, potassium sorbate, purified water, sucralose

Store at room temperature 15°C-29°C (59°F-84°F)

© 2008 Developed and
distributed by Zicam LLC,
Scottsdale, Arizona 85255, a
wholly owned subsidiary of
Matrixx Initiatives, Inc.
(NASDAQ: MTXX)
All rights reserved.

Questions?
Comments?

call 877-942-2626
toll-free or visit us on the
web at www.zicam.com

PRINCIPAL DISPLAY PANEL - 16.3 mL Bottle Carton

NDC 62750-016-10

ZICAM®

CONCENTRATED
COUGH
MAX

Cough Spray
Oral Cough Suppressant Spray

Lasts up to
8 Hours

Cool
Cherry

.55 FL. OZ./16.3 mL

Zicam

Zicam

dextromethorphan hydrobromide SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62750-016
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 6 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 16.3 in 1 BOTTLE, PLASTIC
2 NDC:62750-016-10 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-08-03


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Be sure to consult your doctor before taking any medication!
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