Splash Tears

Splash Tears is an FDA-registered drug product whose active ingredient is HYPROMELLOSE. It is labelled by LABORATORIOS SOPHIA, S.A. DE C.V. taken by ophthalmic and marketed as a human otc drug product. Identifiers on file: NDC 57619-303, application M018, label effective 20260508. It is one of 3 FDA drug label records sharing the active ingredient HYPROMELLOSE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing HYPROMELLOSE are most often described in connection with: temporarily relieves, irritation due, eye discomfort, minor irritations, exposure wind. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily relieves burning and irritation due to dryness of the eye. discomfort due to minor irritations of the eye or to exposure to wind or sun.

Directions instill 1 or 2 drops in the affected eye(s) as needed

Warnings For external use only. Do not use if solution changes color or becomes cloudy. When using this product do not touch tip of container to any surface to avoid contamination. replace cap after using. Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye. condition worsens or persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 3 drug label records with HYPROMELLOSE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Splash Tears used for?
Uses Temporarily relieves burning and irritation due to dryness of the eye. discomfort due to minor irritations of the eye or to exposure to wind or sun.

Who makes Splash Tears?
LABORATORIOS SOPHIA, S.A. DE C.V. is the labeler of record for Splash Tears. 3 FDA label records share the active ingredient HYPROMELLOSE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Splash Tears come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Splash Tears prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing HYPROMELLOSE?
Yes. 3 FDA drug label records list HYPROMELLOSE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Splash Tears been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.