MEDACTIVE ORAL RELIEF- lozenge lozenge

MedActive Oral Relief by

Drug Labeling and Warnings

MedActive Oral Relief by is a Otc medication manufactured, distributed, or labeled by Integrate Oral Care, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 symptons 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 or 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, dimethicone, FD&C Red No. 40, flavor (includes Spilanthes Extract), isomalt, malic acid, poloxamer 338, sucralose, water

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

Ruby Raspberry

Oral Demulcent

Pectin 2.8mg

NDC: 49741-1012-2

20 Lozenges

INGREDIENTS AND APPEARANCE

MEDACTIVE ORAL RELIEF 
lozenge lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49741-1012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	2.8 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
DIMETHICONE (UNII: 92RU3N3Y1O)
MALIC ACID (UNII: 817L1N4CKP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ISOMALT (UNII: S870P55O2W)
POLOXAMER 338 (UNII: F75JV2T505)
WATER (UNII: 059QF0KO0R)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)

Product Characteristics
Color	red (Translucent LIght Red)	Score	no score
Shape	OVAL	Size	22mm
Flavor	RASPBERRY (Ruby Raspberry)	Imprint Code	None
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49741-1012-2	20 in 1 BOX	08/31/2015
1	NDC: 49741-1012-1	1 in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/31/2015

Labeler - Integrate Oral Care, LLC. (063540457)

Registrant - Integrate Oral Care, LLC. (063540457)