Label: ZICAM COUGH MAX- dextromethorphan hydrobromide spray

  • NDC Code(s): 62750-016-10
  • Packager: Matrixx Initiatives, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/09

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 0.25 mL spray)

    Dextromethorphan HBr 6.0 mg

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  • Purpose

    Cough Suppressant

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  • Uses

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

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  • 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.

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  • 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.
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  • Inactive ingredients

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

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  • STORAGE AND HANDLING

    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.

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  • QUESTIONS

    Questions?
    Comments?

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    ZICAM  COUGH MAX
    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) dextromethorphan hydrobromide 6 mg  in 0.25 mL
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62750-016-10 1 in 1 CARTON
    1 16.3 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/03/2005
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    Name Address ID/FEI Business Operations
    Biozone 555564293 Analysis, Manufacture, Relabel, Repack
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