MedActive Oral Relief

Manufacturer
Integrate Oral Care, LLC.
Effective date
2022-12-30
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-05-31 23:52:48

Label at a glance#

ProductMedActive Oral Relief
Active ingredientPECTIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each lozenge)

Pectin 2.8 mg

OTC - PURPOSE SECTION

Purpose

Oral Demulcent

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

DOSAGE & ADMINISTRATION SECTION

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 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 SECTION

Inactive Ingredients

acesulfame potassium, citric acid, dimethicone, flavor (includes Spilanthes Extract), isomalt, malic acid, poloxamer 338, sucrolose, water, xylitol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MedActive® Oral Relief Lozenges

For Relief of Oral Discomfort

with ULTRAMULSION™ & Spilanthes Extract

Natural Spring

Oral Demulcent

Pectin 2.8mg

NDC 49741-1010-2

20 Lozenges

Lozenge Natural SpringLozenge Natural Spring

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637146pectin 2.8 MG Oral LozengePSN12
637146pectin 2.8 MG Oral LozengeSCD12

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49741-1010-22024-01-30C16284748780-11030e365-1685-111a-e063-dadaa90a10e2206eacbd-c6a3-6d72-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49741-1010-1MedActive Oral Relief1 in 1 CELLO PACKLOZENGE112
49741-1010-2MedActive Oral Relief20 in 1 BOXLOZENGE2012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49741-1010MEDACTIVE ORAL RELIEF (LOZENGE) LOZENGE [INTEGRATE ORAL CARE, LLC.]12Legacy NDC, 2 package rows20230101_206eacbd-c6a3-6d72-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49741-101049741-1010-1, 49741-1010-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f113f60d-f52c-9f9a-e053-2a95a90abc0c206eacbd-c6a3-6d72-e054-00144ff8d46c2022-12-30WarningsExact identifier
spl id: f113f60d-f52c-9f9a-e053-2a95a90abc0c
spl set id: 206eacbd-c6a3-6d72-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.