Your browser does not support JavaScript! ZICAM COUGH MAX (DEXTROMETHORPHAN HYDROBROMIDE) SPRAY [MATRIXX INITIATIVES, INC.]
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ZICAM COUGH MAX (dextromethorphan hydrobromide) spray
[Matrixx Initiatives, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dextromethorphan hydrobromide (dextromethorphan) dextromethorphan hydrobromide6 mg  in 0.25 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62750-016-101 in 1 CARTON
116.3 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/03/2005
Labeler - Matrixx Initiatives, Inc. (790037253)
Establishment
NameAddressID/FEIBusiness Operations
Biozone555564293Analysis, Manufacture, Relabel, Repack

Revised: 12/2009
Document Id: 5462b69c-ffa4-4bed-a0c7-2a7af95bb397
Set id: d0ca7e3a-639e-4df4-8f02-3c8d3a2e31ee
Version: 1
Effective Time: 20091228
 
Matrixx Initiatives, Inc.

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