FDA label
What is cyclobenzaprine used for?
The FDA-approved uses of cyclobenzaprine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.”
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Cyclobenzaprine Hydrochloride, tablet, film coated
Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA071611). Cross-references to other label sections are left out.
Cyclobenzaprine HCl is 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 HCl should be used only for short periods (up to two or three 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 HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
Source: DailyMed label, set id 1d9e34cc-eee9-4147-abf8-c810a80e39d2, version 7, effective May 1, 2026. NDC 0093-3420, one of 197 listings for this product.
Cyclobenzaprine Hydrochloride, capsule, extended release
Indications and Usage, quoted from the label by PHOENIX RX LLC (ANDA091281). Cross-references to other label sections are left out.
Cyclobenzaprine hydrochloride extended-release capsules 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, and limitation of motion.
Limitations of Use:
- Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three 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 extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.
Source: DailyMed label, set id 48c33e51-db07-af68-e063-6294a90a897e, version 1, effective January 19, 2026. NDC 85509-1035, one of 16 listings for this product.
Cyclobenzaprine Hydrochloride, tablet
Indications and Usage, quoted from the label by NCS HealthCare of KY, LLC dba Vangard Labs (ANDA218936). Cross-references to other label sections are left out.
Cyclobenzaprine hydrochloride tablets 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 two or three 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 has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
Source: DailyMed label, set id c8566e45-6159-4877-aaa6-1cf968ccb450, version 1, effective September 14, 2026. NDC 0615-8665, one of 8 listings for this product.
Questions
What is cyclobenzaprine used for?
The FDA label says: “Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.”
What drug class is cyclobenzaprine?
FDA lists cyclobenzaprine in the Muscle Relaxant established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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