Label: MEDACTIVE ORAL RELIEF- lozenge lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 30, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient (in each lozenge)

    Pectin 2.8 mg

  • PURPOSE

    Purpose

    Oral Demulcent

  • INDICATIONS & USAGE

    Uses

    • For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.
  • WARNINGS

    Warnings

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Use as needed, up to 8 lozenges per day, or as directed by a dentist or doctor.

    • Adults and children 2 years of age and older: Allow lozenge to dissolve slowly in the mouth. For optimal effect, intermittently position lozenge under the tongue. Do not swallow whole. Do not chew.
    • Children under 12 years of age: Should be supervised in the use of this product.
    • Children under 2 years of age: Consult a dentist or doctor.
  • OTHER SAFETY INFORMATION

    Other Information

    • Store at room temperature.
    • You may experience a slight, temporary tingle sensation upon initial use; this is normal and causes no harm.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    acesulfame potassium, citric acid, dimethicone, flavor (includes Spilanthes Extract), isomalt, malic acid, poloxamer 338, sucrolose, water, xylitol

  • QUESTIONS

    Questions or comments?

    Call toll-free 1-866-887-4867 or visit www.integrateoralcare.com

  • PRINCIPAL DISPLAY PANEL

    MedActive® Oral Relief Lozenges

    For Relief of Oral Discomfort

    with ULTRAMULSION™ & Spilanthes Extract

    Natural Spring

    Oral Demulcent

    Pectin 2.8mg

    NDC 49741-1010-2

    20 Lozenges

    Lozenge Natural Spring

  • INGREDIENTS AND APPEARANCE
    MEDACTIVE ORAL RELIEF 
    lozenge lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49741-1010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN2.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLOXAMER 338 (UNII: F75JV2T505)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ISOMALT (UNII: S870P55O2W)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    MALIC ACID (UNII: 817L1N4CKP)  
    Product Characteristics
    Colorwhite (Opaque White) Scoreno score
    ShapeOVALSize22mm
    FlavorFRUIT (NATURAL SPRING) Imprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49741-1010-220 in 1 BOX08/31/2015
    1NDC:49741-1010-11 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/31/2015
    Labeler - Integrate Oral Care, LLC. (063540457)
    Registrant - Integrate Oral Care, LLC. (063540457)
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