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MedActive Oral Relief by Integrate Oral Care, LLC.

Medically reviewed on November 22, 2017

Dosage form: lozenge
Ingredients: PECTIN 2.8mg
Labeler: Integrate Oral Care, LLC.
NDC Code: 49741-1009

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.

Active Ingredient (in each lozenge)

Pectin 2.8 mg

Purpose

Oral Demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in 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, 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 the reach of children.

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 Information

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

acesulfame potassium,. citric acid, dimethicone, FD&C Yellow No. 5, flavor (includes Spilanthes Extract), isomalt, malic acid, poloxamer 338, sucralose, water

Questions?

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

MedActive® Oral Relief Lozenges

For Relief of Oral Discomfort

with ULTRAMULSION® & Spilanthes Extract

LemonLime

Oral Demulcent

Pectin 2.8mg

NDC 49741-1009-2

20 Lozenges

MEDACTIVE ORAL RELIEF 
lozenge lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49741-1009
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PECTIN (PECTIN) PECTIN2.8 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
DIMETHICONE 
ISOMALT 
POLOXAMER 338 
SUCRALOSE 
WATER 
CITRIC ACID ACETATE 
FD&C YELLOW NO. 5 
MALIC ACID 
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize22mm
FlavorLEMON (LemonLime) Imprint CodeNone
Contains    
Packaging
#Item CodePackage Description
1NDC:49741-1009-220 CELLO PACK in 1 BOX
1NDC:49741-1009-11 LOZENGE in 1 CELLO PACK
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)

 
Integrate Oral Care, LLC.

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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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