QUANTUM HEALTH MEYER LEMON AND HONEY FLAVOR (MENTHOL, UNSPECIFIED FORM) LOZENGE [QUANTUM, INC.]

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QUANTUM HEALTH MEYER LEMON AND HONEY FLAVOR (MENTHOL, UNSPECIFIED FORM) LOZENGE [QUANTUM, INC.]
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NDC 70084-605-18
Set ID fe780067-5a20-4d55-a108-91237cd9e5f4
Category HUMAN OTC DRUG LABEL
Packager Quantum, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each lozenge)

    Menthol 5mg

  • Purposes

    Antitussive (Cough Suppressant) / Oral Anesthetic

  • Uses

    Temporarily relieves:

    • cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants,
    • occasional minor irritation, pain, sore mouth, and sore throat.
  • Warnings

    Sore throat warning

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by a physician.

    Ask a doctor before use if you have

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

    Stop use and ask a doctor if

    • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
    • sore mouth symptoms do not improve in 7 days.

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

    Keep out of reach of children.

  • Directions

    Adults and children 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. Children under 5 years of age: ask a doctor.

  • Other Information

    Store in a cool, dry place.

  • Inactive Ingredients

    Organic Brown Rice Syrup, Organic Cane Syrup, Organic Honey, Natural Meyer Lemon Flavor and Other Natural Flavors, Organic Slippery Elm Bark Powder, and Organic Turmeric.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: QUANTUM, INC.
    PO BOX 2791, EUGENE, OR 97402

  • PRINCIPAL DISPLAY PANEL - 18 Lozenge Bag

    GREAT TASTE

    Quantum®
    HEALTH

    Cough Relief
    LOZENGES

    Natural Menthol Cough Suppressant
    Oral Anesthetic

    MEYER LEMON & HONEY FLAVOR

    MADE WITH NATURAL MEYER LEMON
    FLAVOR AND HONEY

    PROVIDES SOOTHING RELIEF

    USDA
    ORGANIC

    18 Lozenges

    ACTUAL SIZE

    Principal Display Panel - 18 Lozenge Bag
  • INGREDIENTS AND APPEARANCE
    QUANTUM HEALTH MEYER LEMON AND HONEY FLAVOR 
    menthol, unspecified form lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70084-605
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Brown Rice (UNII: 659G217HPG)  
    SUCROSE (UNII: C151H8M554)  
    Honey (UNII: Y9H1V576FH)  
    Ulmus Rubra Bark (UNII: 91QY4PXU8Q)  
    Turmeric (UNII: 856YO1Z64F)  
    Product Characteristics
    ColorYELLOW (Yellowish brown) Scoreno score
    ShapeOVALSize22mm
    FlavorLEMON (Lemon and honey) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70084-605-1818 in 1 BAG; Type 0: Not a Combination Product05/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/01/2017
    Labeler - Quantum, Inc. (044806305)
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