FIRST Baclofen is used in adults and children at least 12 years old to treat muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease.

FIRST Baclofen may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Shake the oral suspension (liquid).

Measure a dose with the supplied measuring device (not a kitchen spoon).

Shake and pour the entire oral granules packet to dissolve in your mouth or swallow whole at once, with or without liquids.

You may also mix the granules with liquids (milk, or apple juice) or soft food (apple sauce, yogurt, or pudding).

The oral granules can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your symptoms do not improve, or if they get worse.

You may have withdrawal symptoms if you stop using FIRST Baclofen suddenly. Ask your doctor before stopping the medicine.

Store the oral suspension (liquid) at room temperature away from moisture and heat. Throw Fleqsuvy away after 2 months of first opening.

Store Ozobax in the refrigerator, do not freeze.

You should not use FIRST Baclofen if you are allergic to it.

Tell your doctor if you have ever had:

• mental illness or psychosis;

• epilepsy or other seizure disorder;

• problems with balance;

• high blood pressure, or fast heart rate;

• a stroke or blood clot; or

• kidney disease.

Using FIRST Baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your own risk.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. If you take FIRST Baclofen while pregnant or breastfeeding, withdrawal symptoms such as tremors, stiff muscles, or seizure may occur in the baby.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include increasing drowsiness, dizziness, sleepiness, trouble focusing on objects, shallow breathing, seizure, or muscle weakness leading to loss of consciousness.

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how FIRST FIRST Baclofen will affect you. Your reactions could be impaired.

Do not share this medicine with another person, even if they have the same symptoms you have.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

FIRST Baclofen may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness, breathing problems;

• confusion, hallucinations;

• muscle weakness, itching, tingling, or twitching in your hands, arms, feet, or legs; or

• fever.

Common side effects of FIRST Baclofen may include:

• drowsiness, dizziness, weakness, or tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using FIRST Baclofen with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect FIRST Baclofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.