Label: ZICAM NATURALS COUGH SUPPRESSANT- mentha piperita liquid 

  • NDC Code(s): 62750-027-10
  • Packager: Matrixx Initiatives, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 11/10

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each 5mL teaspoon)

    Mentha Piperita, 3x

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  • Purpose

    Cough Suppressant

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  • Uses

    • Temporarily controls cough due to minor throat and bronchial irritation
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  • Warnings

    Do not use

    • If you are allergic to peppermint oil/menthol. If an allergic reaction occurs, stop use and seek medical attention right away.
    • In children under 4 years of age.

    Ask a doctor before use if you have

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

    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 you are pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    Adults and children 12 years and older:

    • Take 2 teaspoons (tsp) (10mL).
    • Repeat every 3-4 hours, not to exceed 6 doses per day.
    • Children under 12 years of age: consult a doctor.
    • Children under 4 years of age: do not use.
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  • Other information

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

    citric acid, corn syrup, glycerin, natural cherry flavor, purified water, sodium benzoate

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  • Questions? Comments? Side Effects?

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

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  • SPL UNCLASSIFIED SECTION

    ©2010 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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  • PRINCIPAL DISPLAY PANEL - 120mL Carton

    NDC 62750-027-10

    ZICAM®
    naturals

    NEW!

    COUGH SUPPRESSANT
    MENTHA PIPERITA

    FIGHTS COUGHS
    NATURALLY

    • Fast Acting Relief
    • Dextromethorphan Free

    With
    Peppermint
    Oil

    original
    FLAVOR

    4.0 FL. OZ./120mL

    HOMEOPATHIC

    Principal Display Panel - 120mL Carton
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  • INGREDIENTS AND APPEARANCE
    ZICAM  NATURALS COUGH SUPPRESSANT
    mentha piperita liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62750-027
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    mentha piperita (mentha piperita) mentha piperita 3 [hp_X]  in 188 mL
    Inactive Ingredients
    Ingredient Name Strength
    citric acid monohydrate  
    corn syrup  
    glycerin  
    water  
    sodium benzoate  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62750-027-10 1 in 1 CARTON
    1 120 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 01/01/2011
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    Name Address ID/FEI Business Operations
    Biozone 555564293 MANUFACTURE
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