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Organix Complete by ProPhase Labs, Inc.

Medically reviewed on April 2, 2018

Dosage form: lozenge
Ingredients: Menthol 2.5mg, Pectin 1.7mg
Labeler: ProPhase Labs, Inc.
NDC Code: 61941-0132

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.

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:

  • 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

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

ORGANIX COMPLETE 
menthol and pectin lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0132
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol2.5 mg
Pectin (Pectin) Pectin1.7 mg
Inactive Ingredients
Ingredient NameStrength
Thyme 
Eucalyptus Oil 
Sucrose 
Sage 
Elm 
Sunflower Oil 
Hyssop 
Peppermint Oil 
Product Characteristics
ColorBROWN (Semi-Translucent) Scoreno score
ShapeOVALSize23mm
FlavorCHOCOLATE (Mint Chocolate) Imprint CodeP
Contains    
Packaging
#Item CodePackage Description
1NDC:61941-0132-248 PACKAGE (PACKAGE) in 1 CASE
1NDC:61941-0132-121 LOZENGE (LOZENGE) 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/FEIOperations
ProPhase Labs, Inc.620557298LABEL, ANALYSIS
Establishment
NameAddressID/FEIOperations
Pharmaloz Manufacturing, Inc.067101998MANUFACTURE, ANALYSIS, PACK, REPACK

 
ProPhase Labs, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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