Label: ORGANIX COMPLETE- menthol and pectin lozenge

  • Category: HUMAN OTC DRUG LABEL

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 April 6, 2011

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each drop)Purposes
    Menthol 2.5mgcough suppressant, oral anesthetic
    Pectin 1.7mgoral demulcent
  • Uses

    temporarily relieves:

    • cough associated with a cold or inhaled irritants
    • occasional minor irritation, pain, sore mouth and sore throat
  • Warnings

    Sore throat warning

    if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. Do not give to children under 5 years of age unless directed by a doctor.

    Ask a doctor before use if you have:

    • 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 1 week, tends to reoccur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    • sore mouth does not improve in 7 days
    • irritation, pain or redness persists or worsens

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • adults and children 5 years and older: Dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
    • children under 5 years: ask a doctor
  • Other information

    • store in a cool dry place after opening
  • Inactive ingredients

    citric acid, eucalyptus oil, organic evaporated cane juice, organic honey, organic hyssop, organic lemon oil, organic marshmallow root, organic mullein, organic peppermint oil, organic sage, organic slippery elm, organic sunflower oil, organic tapioca syrup, organic thyme, sucrose

  • Questions? Comments?

    Call 1-800-505-2653 9am-5pm Eastern

  • PRINCIPAL DISPLAY PANEL - 21 Drop Package

    Multi Symptom Relief

    ORganix™
    COMPLETE

    Cough & Sore Throat Drops

    Menthol (from Peppermint Oil) - Cough Suppressant
    Pectin - Oral Demulcent

    Golden Honey Lemon
    Flavor

    MADE WITH
    70% ORGANIC
    INGREDIENTS

    Suppresses Coughs

    Soothes Sore Throats

    Blend of 6 Organic Herbs

    Gluten Free

    21 Drops

    Principal Display Panel - 21 Drop Package
  • INGREDIENTS AND APPEARANCE
    ORGANIX COMPLETE 
    menthol and pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0122
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2.5 mg
    Pectin (UNII: 89NA02M4RX) (Pectin - UNII:89NA02M4RX) Pectin1.7 mg
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Sucrose (UNII: C151H8M554)  
    Sage (UNII: 065C5D077J)  
    Elm (UNII: 63POE2M46Y)  
    Honey (UNII: Y9H1V576FH)  
    Hyssop (UNII: X7HKN4FOJI)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Lemon Oil (UNII: I9GRO824LL)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Thyme (UNII: CW657OBU4N)  
    Product Characteristics
    ColorYELLOW (Semi-Translucent) Scoreno score
    ShapeOVALSize23mm
    FlavorHONEY (Honey Lemon) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0122-248 in 1 CASE
    1NDC:61941-0122-121 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2010
    Labeler - ProPhase Labs, Inc. (620557298)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProPhase Labs, Inc.620557298LABEL, ANALYSIS
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998MANUFACTURE, ANALYSIS, PACK, REPACK
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!