How Supplied Section

HOW SUPPLIED

Cyclobenzaprine Hydrochloride Tablets, USP are available containing 5 mg, 7.5 mg or 10 mg of cyclobenzaprine hydrochloride, USP.

The 5 mg tablets are butter scotch yellow film-coated, round tablets debossed with 020 on one side and plain on other side. They are available as follows:

NDC 52817-330-10

bottles of 100 tablets

NDC 52817-330-50

bottles of 500 tablets

The 7.5 mg tablets are white to off-white film-coated, round tablets debossed with 021 on one side and plain on other side. They are available as follows:

NDC 52817-331-10

bottles of 100 tablets

The 10 mg tablets are orange-yellow film-coated, round tablets debossed with 022 on one side and plain on other side. They are available as follows:

NDC 52817-332-10

bottles of 100 tablets

NDC 52817-332-00

bottles of 1000 tablets

NDC 52817-332-50

bottles of 500 tablets

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Distributed By:

TruPharma, LLC

Tampa,FL 33609

Manufactured by:

Rubicon Research Private Limited,

Ambernath,Dist. Thane,421506 India

Rev. 02, June 2018

Dosage and Administration Section

DOSAGE AND ADMINISTRATION

For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of cyclobenzaprine hydrochloride tablets for periods longer than 2 or 3 weeks is not recommended (see INDICATIONS AND USAGE).

Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS: IMPAIRED HEPATIC FUNCTION, and Use in the Elderly).

Indications and Usage Section

INDICATIONS AND USAGE

Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.

Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

Principal Display Panel