ORGANIX COMPLETE- menthol and pectin lozenge 
ProPhase Labs, Inc.

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.

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Organix Complete
Cough & Sore Throat Drops

Drug Facts

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

Uses

temporarily relieves:

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

Other information

Inactive ingredients

natural flavors, organic caramel color, organic evaporated cane juice, organic hyssop, 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

Mint Chocolate
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
ORGANIX COMPLETE 
menthol and pectin lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0132
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
Thyme (UNII: CW657OBU4N)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Sucrose (UNII: C151H8M554)  
Sage (UNII: 065C5D077J)  
Elm (UNII: 63POE2M46Y)  
Sunflower Oil (UNII: 3W1JG795YI)  
Hyssop (UNII: X7HKN4FOJI)  
Peppermint Oil (UNII: AV092KU4JH)  
Product Characteristics
ColorBROWN (Semi-Translucent) Scoreno score
ShapeOVALSize23mm
FlavorCHOCOLATE (Mint Chocolate) Imprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61941-0132-248 in 1 CASE
1NDC:61941-0132-121 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

Revised: 4/2011
Document Id: f5c05aa5-6b4c-4a6c-ba9b-2fe1cc8bce03
Set id: a525d0c3-6526-4cb1-a3a3-f434119b6826
Version: 1
Effective Time: 20110401
 
ProPhase Labs, Inc.