Otc - Active Ingredient
Active Ingredient (in each lozenge)
Pectin 2.8 mg
Medactive Oral Relief
FDA Label NDC 49741-1012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Integrate Oral Care, Llc. for the product Medactive Oral Relief (NDC 49741-1012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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
Otc - Questions
Questions or comments?
Call toll-free 1-866-887-4867 or visit www.integrateoralcare.com
Package Label.Principal Display Panel
Lozenge Ruby Raspberry (Loz Rr 20 Demulcent Rev5)
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
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