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| Product NDC Code | 0904-6848 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Major lubricating eye drops |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||||
| Dosage Form | SOLUTION/ DROPS | ||||||
| RxCUI drug identifier | 1188426 | ||||||
| Application Number | M018 | ||||||
| Labeler Name | Harvard Drug Group L L C | ||||||
| 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.Active ingredient Carboxymethylcellulose sodium 0.5%
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.Directions to open, twist and pull tab to remove instill 1 or 2 drops in the affected eye(s) as needed and discard container if used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor's instructions
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients calcium chloride, **hydrochloric acid, magnesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate. **May contain these ingredients to adjust pH.
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.Uses for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun may be used as a protectant against further irritation
Purpose
Information about the drug product’s indications for use.Purpose Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Major Lubricating Eye Drops Carboxymethylcellulose Sodium MAGNESIUM CHLORIDE SODIUM CHLORIDE SODIUM HYDROXIDE HYDROCHLORIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CARBOXYMETHYLCELLULOSE WATER SODIUM LACTATE CALCIUM CHLORIDE POTASSIUM CHLORIDE
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.Major Lubricating Eye Drops 30ct Major Lubricating Eye Drops 30ct
Major Lubricating Eye Drops 50ct Major Lubricating Eye Drops 50ct
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.Do not use this product if solution changes color or becomes cloudy
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.Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at 15°-25°C (59°-77°) use only if single use container is intact use before expiration date marked on container RETAIN THIS CARTON FOR FUTURE REFERENCE
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call (800) 616-2471
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.Stop use and ask a doctor if you experience eye pain changes in vision occur redness or irritation of the eye continues redness or irritation of the eye worsens or persists for more than 72 hours
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.When using this product do not reuse once opened, discard to avoid contamination, do not touch tip of container to any surface do not touch unit-dose tip to eye
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 For external use only Do not use this product if solution changes color or becomes cloudy When using this product do not reuse once opened, discard to avoid contamination, do not touch tip of container to any surface do not touch unit-dose tip to eye Stop use and ask a doctor if you experience eye pain changes in vision occur redness or irritation of the eye continues redness or irritation of the eye worsens or persists for more than 72 hours Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
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