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IMPORTANT SAFETY INFORMATION about ELYXYB®

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

Gastrointestinal Bleeding, Ulceration, and Perforation

APPROVED USE

ELYXYB® (celecoxib) oral solution is:

A prescription nonsteroidal anti-inflammatory drug (NSAID) used for the acute treatment of migraine with or without aura in adults.

Important information about ELYXYB:

ELYXYB contains celecoxib, a NSAID. NSAIDs, including ELYXYB, can cause serious side effects, including:

Do not take ELYXYB right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDs, including ELYXYB, after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

ELYXYB should only be used:

Do not take ELYXYB:

Don’t start a new medication before talking to your healthcare provider and telling them about all of the medications you take.

Before taking ELYXYB, tell your healthcare provider about all of your medical conditions, including if you:

When taking ELYXYB

See the detailed “Instructions for Use” on how to take ELYXYB solution.

The possible side effects of ELYXYB are:

liver problems including liver failure, new or worse high blood pressure, heart failure, kidney problems including kidney failure, life-threatening allergic reactions, asthma attacks in people who have asthma, life-threatening skin reactions, medication overuse headaches, low red blood cells (anemia). Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Stop taking ELYXYB and call your healthcare provider right away if you get any of the following symptoms:

Get emergency help right away if you have:

Shortness of breath or trouble breathing, chest pain, weakness in one part or side of your body, slurred speech, or swelling of the face or throat.

If you take too much ELYXYB, call your healthcare provider or get medical help right away.

These are not all the side effects associated with ELYXYB. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
Please see full Prescribing Information, including Boxed Warning and Medication Guide for ELYXYB.