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| Product NDC Code | 82091-112 | ||||
|---|---|---|---|---|---|
| Drug Name | Kaylaan |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| Application Number | part355 | ||||
| Labeler Name | Kaylaan LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.OTC-ACTIVE INGREDIENT SECTION
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE & ADMINISTRATION SECTION
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT SECTION
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATION & USAGE SECTION
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE SECTION
Spl product data elements
Usually a list of ingredients in a drug product.KAYLAAN Zero Waste Refill For Toothpaste CALCIUM CARBONATE STEVIA LEAF SODIUM FLUORIDE FLUORIDE ION ERYTHRITOL MAGNESIUM STEARATE SODIUM BICARBONATE SODIUM COCOYL ISETHIONATE XANTHAN GUM MINT XYLITOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Dosage and Adminstration section falls under direction. INDICATION AND USAGE updated DOSAGE & ADMINISTRATION SECTION
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.OTC-KEEP OUT OF REACH OF CHILDREN SECTION
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API