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| Product NDC Code | 51801-016 | ||||
|---|---|---|---|---|---|
| Drug Name | Viva hydration boost |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| Application Number | M018 | ||||
| Labeler Name | Nomax Inc | ||||
| 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.Glycerin 0.25%
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.Glycerin 0.25% Instill 1 or 2 drops in the affected eye(s) as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.borate, boric acid, sodium chloride, calcium chloride, l-carnitine, sodium hyluronate
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.for the temporary relief of burning and irritation due to dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye or to the exposure to wind or sun for use as a protectant against further irritation or to temporarily relieve dryness of the eye
Purpose
Information about the drug product’s indications for use.Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Viva Hydration Boost Glycerin LEVOCARNITINE HYALURONATE SODIUM SODIUM CHLORIDE CALCIUM CHLORIDE BORIC ACID GLYCERIN GLYCERIN SODIUM BORATE
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.VIVA dry eye therapy hydration lubricating eye drops instant, moisture for dry, irritated eyes Preservative-Free For irritated, dry eyes pH Balanced for comfort See inside leaflet for additional information and how to use Sterile .33 fl oz (10mL) Preservative-Free Multi-Dose Bottle carton copy
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.if solution changes color or becomes cloudy if tamper evident ring is broken or missing
Instructions for use
Information about safe handling and use of the drug product.instill 1 or 2 drops in the affected eye(s) as needed
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.if swallowed, get medical help or contact a Poison Control Center right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Amcon Laboratories, Inc. St. Louis, MO 63123 1.800.255.6161 email: [email protected]
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.IF you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.do not touch tip of container to any surface to avoid contamination replace cap after use
Storage and handling
Information about safe storage and handling of the drug product.Store at 15-25ºC (55-77ºF) LOT number and expiration date on bottom of box and bottle
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.For external use only
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