SPL v12
SPL
SPL Set ID 2bd43c6c-93ae-1e94-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2015-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pectin (2.8 mg)
Inactive Ingredients
Malic Acid Acesulfame Potassium Dimethicone Isomalt Poloxamer 338 Sucralose Water Citric Acid Acetate Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: yellow Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-08-31

Description

Active Ingredient (in each lozenge) Pectin 2.8 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Dosage and 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 of age: Should be supervised in the use of this product.
  • Children under 2 years of age: Consult a dentist or doctor.
Description

Active Ingredient (in each lozenge) Pectin 2.8 mg

Section 50565-1

Keep out of the reach of children.

Section 51727-6

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

Section 51945-4

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

Section 53413-1

Questions?

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

Section 55105-1

Purpose

Oral Demulcent

Section 55106-9

Active Ingredient (in each lozenge)

Pectin 2.8 mg

Section 60561-8

Other Information

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

Structured Label Content

Indications and Usage (34067-9)

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions?

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

Section 55105-1 (55105-1)

Purpose

Oral Demulcent

Section 55106-9 (55106-9)

Active Ingredient (in each lozenge)

Pectin 2.8 mg

Section 60561-8 (60561-8)

Other Information

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

Advanced Ingredient Data


Raw Label Data

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