SPL v13
SPL
SPL Set ID 2b72623f-1642-6613-e054-00144ff8d46c
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
Isomalt Acesulfame Potassium Fd&c Yellow No. 6 Citric Acid Acetate Dimethicone Malic Acid Poloxamer 338 Sucralose Water

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: orange 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

Inactive Ingredients

acesulfame potassium, citric acid, dimethicone, FD&C Yellow No. 6, 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

Orange Crème

Oral Demulcent

Pectin 2.8mg

NDC 49741-1011-2

20 Lozenges

Section 53413-1

Questions or comments?

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)

Inactive Ingredients

acesulfame potassium, citric acid, dimethicone, FD&C Yellow No. 6, 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

Orange Crème

Oral Demulcent

Pectin 2.8mg

NDC 49741-1011-2

20 Lozenges

Section 53413-1 (53413-1)

Questions or comments?

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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