INSTRUCTIONS FOR USE

Cyclobenzaprine Hydrochloride Extended-Release Capsules

Read this Instructions for Use before you prepare your first dose of cyclobenzaprine hydrochloride extended-release capsules mixed with applesauce using the capsule sprinkle method, each time you get a refill, and as needed. There may be new information. Ask your healthcare provider or pharmacist if you have any questions about how to mix or give a dose of cyclobenzaprine hydrochloride extended-release capsules using the capsule sprinkle method.

Important Information:

Do not chew cyclobenzaprine hydrochloride extended-release capsules or the granules that are in the capsules.
The capsule sprinkle method for mixing the contents of cyclobenzaprine hydrochloride extended-release capsules with applesauce may be used for adults who cannot swallow capsules. Do not use any other food in the place of applesauce.

Preparing a dose of cyclobenzaprine hydrochloride extended-release capsules using the capsule sprinkle method.

Before you prepare a dose of cyclobenzaprine hydrochloride extended-release capsules mixed with applesauce using the capsule sprinkle method, gather the following supplies:

paper towels
tablespoon
applesauce
cup of water

Step 1: Choose a clean, flat work surface. Place a clean paper towel on the work surface. Then place the other supplies on the paper towel.
Step 2: Wash and dry your hands well.
Step 3: Check the dose that was prescribed by your healthcare provider. Take out the number of cyclobenzaprine hydrochloride extended-release capsules needed to prepare your dose. Place them on the paper towel.
Step 4: Place enough applesauce to fill your tablespoon. Set the tablespoon down on the paper towel. [image]
Step 5: Hold the cyclobenzaprine hydrochloride extended-release capsule in an upright position (vertical) directly over the tablespoon. Hold each end of the cyclobenzaprine hydrochloride extended-release capsule between your thumbs and index (pointer) fingers. [image]
Step 6: Carefully twist both ends of the cyclobenzaprine hydrochloride extended-release capsule in opposite directions to open it. Be careful not to spill the capsule contents. [image]

Step 7: Sprinkle the contents of the cyclobenzaprine hydrochloride extended-release capsule onto the applesauce.

Check the capsule shells to make sure they are empty.
Throw away the empty capsule shells.

If the total prescribed dose is more than 1 capsule, repeat Steps 5 through 7 for each capsule. Do not add more applesauce. Then follow the rest of the steps below. [image]
Step 8: Pick up the tablespoon and swallow the cyclobenzaprine hydrochloride extended-release capsule contents and applesauce mixture right away. Do not chew the cyclobenzaprine hydrochloride extended-release capsule contents and applesauce mixture. [image]
Step 9: Rinse your mouth with a sip of water and swallow to make sure that all of the cyclobenzaprine hydrochloride extended-release capsule granules have been swallowed. [image]
Step 10: Throw away any unused cyclobenzaprine hydrochloride extended-release capsule content and applesauce mixture. Do not keep any cyclobenzaprine hydrochloride extended-release capsule content and applesauce mixture for future use.

How should I store cyclobenzaprine hydrochloride extended-release capsules?

Store cyclobenzaprine hydrochloride extended-release capsules at room temperature between 68°F to 77°F (20°C to 25°C).

Keep cyclobenzaprine hydrochloride extended-release capsules and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

CHERCIFU-001

Issued: May 2019