ZICAM COUGH MAX- dextromethorphan hydrobromide spray 
Matrixx Initiatives, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ZICAM®

Active ingredient (in each 0.25 mL spray)

Dextromethorphan HBr 6.0 mg

Purpose

Cough Suppressant

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

PRINCIPAL DISPLAY PANEL - 16.3 mL Bottle Carton
ZICAM  COUGH MAX
dextromethorphan hydrobromide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) dextromethorphan hydrobromide6 mg  in 0.25 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62750-016-101 in 1 CARTON08/03/200508/15/2017
116.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/03/200508/15/2017
Labeler - Matrixx Initiatives, Inc. (790037253)

Revised: 8/2017
Document Id: 62d8d364-d52c-4bad-924d-1cfbfa665791
Set id: d0ca7e3a-639e-4df4-8f02-3c8d3a2e31ee
Version: 2
Effective Time: 20170824
 
Matrixx Initiatives, Inc.