Medicine guide

Cyclobenzaprine Hydrochloride

10 mg · Tablet, Film Coated

Prescription only
Muscle Relaxant

Active substance: Cyclobenzaprine Hydrochloride
Used in: Muscles, joints and bones
Made by: Cardinal Health 107, LLC
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-07-30

What it is

Muscle Relaxant

Used for

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.

The label’s usual adult dose

For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets is 5 mg three times a day.

Full directions ↓

Do not take it if

Hypersensitivity to any component of this product.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

128other products contain Cyclobenzaprine Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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

From the official label · 2026-07-30 · DailyMed

How it works

From this product’s own US prescribing label.

Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function.
It is ineffective in muscle spasm due to central nervous system disease.

Half-life18 h

Mostly cleared after≈ 4 daysfive half-lives — our arithmetic

How the body breaks it down

Cyclobenzaprine is extensively metabolized, and is excreted primarily as glucuronides via the kidney.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-30

Do not take it if

Hypersensitivity to any component of this product.
Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation.
Hyperpyretic crisis seizures, and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs.
Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
Hyperthyroidism.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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 two or three 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 ).

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine hydrochloride when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.
The concomitant use of cyclobenzaprine hydrochloride with MAO inhibitors is contraindicated (see CONTRAINDICATIONS ).
Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Treatment with cyclobenzaprine hydrochloride and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated.
If concomitant treatment with cyclobenzaprine hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see PRECAUTIONS, Drug Interactions ).
Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine.
In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see WARNINGS , below, and ADVERSE REACTIONS ).
Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.
General Because of its atropine-like action, cyclobenzaprine hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.
Impaired Hepatic Function The plasma concentration of cyclobenzaprine is increased in patients with hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Hepatic Impairment ).
These patients are generally more susceptible to drugs with potentially sedating effects, including cyclobenzaprine.
Cyclobenzaprine hydrochloride should be used with caution in subjects with mild hepatic impairment starting with a 5 mg dose and titrating slowly upward.
Due to the lack of data in subjects with more severe hepatic insufficiency, the use of cyclobenzaprine hydrochloride in subjects with moderate to severe impairment is not recommended.
Information for Patients Cyclobenzaprine hydrochloride, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.
Drug Interactions Cyclobenzaprine may have life-threatening interactions with MAO inhibitors (see CONTRAINDICATIONS ).
Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol. 2 2 ULTRAM ® (tramadol HCl tablets, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.) ULTRACET ® (tramadol HCl and acetaminophen tablets, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.) Carcinogenesis, Mutagenesis, Impairment of Fertility In rats treated with cyclobenzaprine hydrochloride for up to 67 weeks at doses of approximately 5 to 40 times the maximum recommended human dose, pale, sometimes enlarged, livers were noted and there was a dose-related hepatocyte vacuolation with lipidosis.
In the higher dose groups this microscopic change was seen after 26 weeks and even earlier in rats which died prior to 26 weeks; at lower doses, the change was not seen until after 26 weeks.
Cyclobenzaprine did not affect the onset, incidence or distribution of neoplasia in an 81-week study in the mouse or in a 105-week study in the rat.
At oral doses of up to 10 times the human dose, cyclobenzaprine did not adversely affect the reproductive performance or fertility of male or female rats.
Cyclobenzaprine did not demonstrate mutagenic activity in the male mouse at dose levels of up to 20 times the human dose.
Pregnancy:
Nursing Mothers It is not known whether this drug is excreted in human milk.
Pediatric Use Safety and effectiveness of cyclobenzaprine hydrochloride in pediatric patients below 15 years of age have not been established.
Use in the Elderly The plasma concentration of cyclobenzaprine is increased in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly ).
General Because of its atropine-like action, cyclobenzaprine hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.
Impaired Hepatic Function The plasma concentration of cyclobenzaprine is increased in patients with hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Hepatic Impairment ).
These patients are generally more susceptible to drugs with potentially sedating effects, including cyclobenzaprine.
Cyclobenzaprine hydrochloride should be used with caution in subjects with mild hepatic impairment starting with a 5 mg dose and titrating slowly upward.
Due to the lack of data in subjects with more severe hepatic insufficiency, the use of cyclobenzaprine hydrochloride in subjects with moderate to severe impairment is not recommended.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Pregnancy Category B Reproduction studies have been performed in rats, mice and rabbits at doses up to 20 times the human dose, and have revealed no evidence of impaired fertility or harm to the fetus due to cyclobenzaprine hydrochloride.
There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk.
Because cyclobenzaprine is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, caution should be exercised when cyclobenzaprine hydrochloride is administered to a nursing woman.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Cyclobenzaprine may have life-threatening interactions with MAO inhibitors (see CONTRAINDICATIONS ).
Postmarketing cases of serotonin syndrome have been reported during combined use of cyclobenzaprine hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.
If concomitant treatment with cyclobenzaprine hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see WARNINGS ).
Cyclobenzaprine hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.
Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.
Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol. 2 2 ULTRAM ® (tramadol HCl tablets, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.) ULTRACET ® (tramadol HCl and acetaminophen tablets, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.)

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Although rare, deaths may occur from overdosage with cyclobenzaprine hydrochloride.
Multiple drug ingestion (including alcohol) is common in deliberate cyclobenzaprine overdose.
As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.
Signs and symptoms of toxicity may develop rapidly after cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible.
The acute oral LD 50 of cyclobenzaprine hydrochloride is approximately 338 and 425 mg/kg in mice and rats, respectively.
Manifestations The most common effects associated with cyclobenzaprine overdose are drowsiness and tachycardia.
Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.
Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome.
Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of cyclobenzaprine toxicity.
Other potential effects of overdosage include any of the symptoms listed under ADVERSE REACTIONS .
Management General As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.
In order to protect against the rare but potentially critical manifestations described above, obtain an ECG and immediately initiate cardiac monitoring.
Protect the patient’s airway, establish an intravenous line and initiate gastric decontamination.
Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.
If signs of toxicity occur at any time during this period, extended monitoring is required.
Monitoring of plasma drug levels should not guide management of the patient.
Dialysis is probably of no value because of low plasma concentrations of the drug.
Gastrointestinal Decontamination All patients suspected of an overdose with cyclobenzaprine hydrochloride should receive gastrointestinal decontamination.
This should include large volume gastric lavage followed by activated charcoal.
If consciousness is impaired, the airway should be secured prior to lavage and emesis is contraindicated.
Cardiovascular A maximal limb-lead QRS duration of ≥0.10 seconds may be the best indication of the severity of the overdose.
Serum alkalinization, to a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and hyperventilation (as needed), should be instituted for patients with dysrhythmias and/or QRS widening.
A pH >7.60 or a pCO 2 <20 mmHg is undesirable.
Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin.
Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).
CNS In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration.
Seizures should be controlled with benzodiazepines or, if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin).
Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in close consultation with a poison control center.
Psychiatric Follow-Up Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase.
Psychiatric referral may be appropriate.
Pediatric Management The principles of management of child and adult overdosages are similar.
It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine hydrochloride is administered, even though they have not been reported to occur with this drug.
Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise.
These are not indicative of addiction.

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

Safety and effectiveness of cyclobenzaprine hydrochloride in pediatric patients below 15 years of age have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

in the Elderly The plasma concentration of cyclobenzaprine is increased in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly ).
The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions.
For these reasons, in the elderly, cyclobenzaprine should be used only if clearly needed.
In such patients cyclobenzaprine hydrochloride should be initiated with a 5 mg dose and titrated slowly upward.

Quoted from the official label, section “Geriatric Use”.

Side effects

Incidence of most common adverse reactions in the 2 double-blind 3 , placebo-controlled 5 mg studies (incidence of > 3% on cyclobenzaprine hydrochloride 5 mg):
Cyclobenzaprine Hydrochloride 5 mg Cyclobenzaprine Hydrochloride 10 mg Placebo N=464 N=249 N=469 Drowsiness 29% 38% 10% Dry Mouth 21% 32% 7% Fatigue 6% 6% 3% Headache 5% 5% 8% Adverse reactions which were reported in 1% to 3% of the patients were:
abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.
The following list of adverse reactions is based on the experience in 473 patients treated with cyclobenzaprine hydrochloride 10 mg in additional controlled clinical studies, 7607 patients in the postmarketing surveillance program, and reports received since the drug was marketed.
The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies.
The adverse reactions reported most frequently with cyclobenzaprine hydrochloride were drowsiness, dry mouth and dizziness.
The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies:
3 Note:
Cyclobenzaprine hydrochloride 10 mg data are from one clinical trial.
Cyclobenzaprine hydrochloride 5 mg and placebo data are from two studies.
Clinical Studies With Cyclobenzaprine Hydrochloride 10 mg Surveillance Program With Cyclobenzaprine Hydrochloride 10 mg Drowsiness 39% 16% Dry Mouth 27% 7% Dizziness 11% 3% Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program.
Adverse reactions which were reported in 1% to 3% of the patients were:
fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.
The following adverse reactions have been reported in post-marketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet:
Body as a Whole:
Syncope; malaise.
Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension.
Digestive:
Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis.
Hypersensitivity: Anaphylaxis; angioedema; pruritus; facial edema; urticaria; rash.
Musculoskeletal: Local weakness.
Nervous System and Psychiatric:
Seizures, ataxia; vertigo; dysarthria; tremors; hypertonia; convulsions; muscle twitching; disorientation; insomnia; depressed mood; abnormal sensations; anxiety; agitation; psychosis, abnormal thinking and dreaming; hallucinations; excitement; paresthesia; diplopia, serotonin syndrome.
Skin: Sweating.
Special Senses: Ageusia; tinnitus.
Urogenital: Urinary frequency and/or retention.
Causal Relationship Unknown Other reactions, reported rarely for cyclobenzaprine hydrochloride under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians:
Body as a whole:
Chest pain; edema.
Cardiovascular: Hypertension; myocardial infarction; heart block; stroke.
Digestive: Paralytic ileus, tongue discoloration; stomatitis; parotid swelling.
Endocrine: Inappropriate ADH syndrome.
Hematic and Lymphatic:
Purpura; bone marrow depression; leukopenia; eosinophilia; thrombocytopenia.
Metabolic, Nutritional and Immune:
Elevation and lowering of blood sugar levels; weight gain or loss.
Musculoskeletal: Myalgia.
Nervous System and Psychiatric:
Decreased or increased libido; abnormal gait; delusions; aggressive behavior; paranoia; peripheral neuropathy;
Bell’s palsy; alteration in EEG patterns; extrapyramidal symptoms.
Respiratory: Dyspnea.
Skin: Photosensitization; alopecia.
Urogenital:
Impaired urination; dilatation of urinary tract; impotence; testicular swelling; gynecomastia; breast enlargement; galactorrhea.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Cyclobenzaprine hydrochloride, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.
In the elderly, the frequency and severity of adverse events associated with the use of cyclobenzaprine, with or without concomitant medications, is increased.
In elderly patients, cyclobenzaprine hydrochloride should be initiated with a 5 mg dose and titrated slowly upward.
Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of cyclobenzaprine hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors.
Patients should be advised of the signs and symptoms of serotonin syndrome, and be instructed to seek medical care immediately if they experience these symptoms (see WARNINGS , and see PRECAUTIONS , Drug Interactions ).

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

Cyclobenzaprine Hydrochloride Tablets USP, 10 mg are butterscotch yellow, biconvex, 5-sided D-shaped film-coated tablets, debossed with ‘D’ and ‘32’ on one side and plain on other side.
Overbagged with 10 film-coated tablets per bag, NDC 55154-0190-0 WARNING:
This Unit Dose package is not child resistant and is Intended for Institutional Use Only.
Keep this and all drugs out of the reach of children.
STORAGE
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Distributed by: Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816 Packaged and Distributed by:
MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Distributed By:
Cardinal Health Dublin, OH 43017 L60439540825 Made in India Code:
TS/DRUGS/19/1993 Issued:
05/2021

Quoted from the official label, section “How Supplied”.

What is in it

Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C 20 H 21 N
HCl and a molecular weight of 311.9. It has a melting point of 217ºC, and a pK a of 8.47 at 25ºC. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-( 5H -dibenzo[ a , d ] cyclohepten-5-ylidene)- N, N -dimethyl-1-propanamine hydrochloride, and has the following structural formula:
Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients:
croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide. In addition 5 mg also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP. Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (53)

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Every strength and form (12)

Details

Made by	Cardinal Health 107, LLC
Active substance	Cyclobenzaprine Hydrochloride
Used in	Muscles, joints and bones
Strength	10 mg
Form	Tablet, Film Coated
Route	Oral
Packs	10 BLISTER PACK in 1 BAG / 1 TABLET, FILM COATED in 1 BLISTER PACK
NDC	55154-0190

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

133 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet, Film Coated105 products
- 5 mg38
  5 mg · 38 companies
  +30 more
- 7.5 mg21
  7.5 mg · 21 companies
  +13 more
- 10 mg46
  10 mg · 46 companies
  +38 more
Capsule, Extended Release22 products
- 15 mg14
  15 mg · 14 companies
  +6 more
- 30 mg8
  30 mg · 8 companies
Tablet6 products
- 5 mg
- 10 mg5
  10 mg · 5 companies

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Cyclobenzaprine Hydrochloride