MedActive Oral Relief
- Manufacturer
- Integrate Oral Care, LLC.
- Effective date
- 2022-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 11
- Source
- full-release
- Hydrated at
- 2026-05-31 23:52:48
Label at a glance#
Contacts and useful links#
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
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.
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 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 SECTION
Inactive Ingredients
acesulfame potassium, dimethicone, FD&C Red No. 40, flavor (includes Spilanthes Extract), isomalt, malic acid, poloxamer 338, sucralose, water
OTC - QUESTIONS SECTION
Questions or comments?
Call toll-free
1-866-887-4867 or visit
www.integrateoralcare.com
PACKAGE LABEL.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
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49741-1012-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3ebb-111a-e063-dadaa90a10e2 | 2bd2e748-bad8-6ad9-e054-00144ff88e88 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49741-1012-1 | MedActive Oral Relief | 1 in 1 CELLO PACK | LOZENGE | 1 | 11 | |
| 49741-1012-2 | MedActive Oral Relief | 20 in 1 BOX | LOZENGE | 20 | 11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49741-1012 | MEDACTIVE ORAL RELIEF (LOZENGE) LOZENGE [INTEGRATE ORAL CARE, LLC.] | 11 | Legacy NDC, 2 package rows | 20230101_2bd2e748-bad8-6ad9-e054-00144ff88e88.zip |
Products#
Every source-derived product name is available through these pages.
- MedActive Oral Relief
- Lozenge
- FD&C RED NO. 40
- PECTIN
- DIMETHICONE
- MALIC ACID
- SUCRALOSE
- ISOMALT
- POLOXAMER 338
- WATER
- ACESULFAME POTASSIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49741-1012 | 49741-1012-1, 49741-1012-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| PECTIN | 89NA02M4RX | ACTIB |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| MALIC ACID | 817L1N4CKP | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ISOMALT | S870P55O2W | IACT |
| POLOXAMER 338 | F75JV2T505 | IACT |
| WATER | 059QF0KO0R | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f114122c-4b9c-f1ad-e053-2995a90aa66b | 2bd2e748-bad8-6ad9-e054-00144ff88e88 | 2022-12-30 | Warnings | f114122c-4b9c-f1ad-e053-2995a90aa66b 2bd2e748-bad8-6ad9-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
