The Directions section on an eye drop label

The Directions section of an eye drop’s Drug Facts label tells you how much to use, how often, and in which eyes. Under FDA’s labeling rule, 21 CFR 201.66, it comes right after Warnings and repeats the directions from the product’s OTC monograph or approved application. Quell’s reads: Apply 1 drop 3 times per day in each eye. Anything it doesn’t cover, such as contact lenses, children or other drops, is a question for your eye doctor or pharmacist.

Where Directions sits on the Drug Facts panel

Every over-the-counter drug in the United States uses the same Drug Facts layout, set by the FDA in 21 CFR 201.66. The headings always appear in the same order, so you can find the same information on any box:

• Active ingredient(s), with the amount of each.
• Purpose(s), the job each active ingredient does.
• Use(s), what the product is for.
• Warnings, including when not to use it and when to stop.
• Directions, how to use it.
• Other information, such as storage.
• Inactive ingredients.
• Questions?, with a phone number, when the label includes it.

Directions coming after Warnings is deliberate: you’re meant to know who shouldn’t use the product and what to watch for before you read how to use it. Our guide on how to read a Drug Facts label walks through the whole panel.

What the FDA rule says goes in it

The regulation’s wording for this section is short. Under the heading “Directions,” a label gives the directions for use described in the applicable OTC monograph or in the product’s approved drug application. In other words, the directions on a monograph product aren’t invented by the brand; they follow the standard that product is made under. Our guide to the OTC monograph for eye drops explains what that standard is.

The same rule sets some formatting. When a section has more than one statement, each gets its own bullet. When directions differ for three or more age groups or populations, they go into a table. That’s why some products show a grid of ages and doses, while a single-line instruction, like Quell’s, appears as one statement.

Eye drop directions: reading Quell’s

Quell’s Directions section says: Apply 1 drop 3 times per day in each eye. It answers three questions in one line:

• How much: the number of drops per eye at each use.
• How often: the number of times per day.
• Where: each eye, not just the one that feels worse.

Read it as the label’s instruction, not a starting point to adjust. If a long day makes you want to use more, or one eye feels fine and you’d rather skip it, that’s a conversation for your eye doctor. Our guide on how many drops to use explains why one drop is usually all the eye can hold.

How often to use eye drops

This is one of the most common questions about any drop, and the Directions section is where the answer lives. It varies by product, which is why it’s worth reading the panel of whatever bottle you’re holding rather than going by habit or by what a friend uses. For Quell, the frequency is part of the single direction quoted above. The label doesn’t say what time of day to use it, so many people tie the doses to routines they already have, like breakfast, mid-afternoon and bedtime.

Lines that work with Directions

Directions don’t stand alone. Other sections of the same panel finish the picture:

• When using this product: Do not touch tip of bottle to any surface to avoid contamination.
• Do not use: If this product changes color.
• Other information: Store between 15° to 30°C (59° to 86°F). Also: Product appears as a milky brown solution.
• Warnings: Caution should be used in those with egg or bird allergies — For use in the eyes only.

The stop-use guidance belongs to the Warnings section, not Directions, but it decides how long you should keep going without seeing someone. On Quell’s label it amounts to this: Stop use and ask a doctor if you feel eye pain or changes in your vision, if irritation or redness continues, or if the condition worsens or persists for 72 hours.

What the Directions section leaves out

A short direction line covers the typical adult user and nothing more. Quell’s label is silent on several situations people ask about:

• Contact lenses: the label doesn’t say whether to use it with lenses in or out, or how long to wait.
• Children: there are no directions for children, and no age table.
• Other eye drops: there’s nothing about using it alongside prescribed or other OTC drops, or how to space them.
• Time of day and how many days in a row: beyond the stop-use guidance, the label doesn’t set a schedule.

When the label is silent, don’t fill the gap with a guess. Ask your eye doctor, who knows your eyes, or a pharmacist, who can check your other medicines. Our guide to using eye drops as directed covers technique.

Questions about the label

If something about Quell’s label is unclear, you can call Aurora Pharmaceuticals, LLC at 615.465.6041, M–F 9AM–5PM CST. The full panel, exactly as printed, is on our Drug Facts page.