CYCLOBENZAPRINE HYDROCHLORIDE tablet

CYCLOBENZAPRINE HYDROCHLORIDE by

Drug Labeling and Warnings

CYCLOBENZAPRINE HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by Alivio Medical Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Each film-coated tablet contains:

Cyclobenzaprine Hydrichloride, USP 10 mg

DESCRIPTION

Usual Adult Dosage:

See package outsert for dosage information

STORAGE AND HANDLING

This container is not intended for household use.

Dispense contents with a child-resistant closure

(as required) and in tight, light-resistant container

as defined in the USP.

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]. KEEP THIS

AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

DESCRIPTION

DESCRIPTION

Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical

formula C20H21N-HCl and a molecular weight of 311.9.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY

Cyclobenzaprine HCl relieves skeletal muscle spasm of local origin without interfering with muscle

function. It is ineffective in muscle spasm due to central nervous system disease.

INDICATIONS & USAGE

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 muscoskeletal conditions.

CONTRAINDICATIONS

CONTRAINDICATIONS

Hypersensitivity to any component of this product. Concomitant use of monoamine oxidase (MAO)

inhibitors or within 14 days after their discontinuation.

WARNINGS

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, verapimal,, or (MAO) inhibitors.

PRECAUTIONS

PRECAUTIONS

General. Because of its atropine - like action, cyclobenzaprine hydrochloride should be sued with caution

in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure and

in patients taking anticholinergic medication.

ADVERSE REACTIONS

ADVERSE REACTIONS

Incidence of most common adverse reactions in the 2 double-blind, placebo controlled - 5 mg studies

(incidence of >3% on cyclobenzaprine hydrochloride 5 mg

DRUG ABUSE AND DEPENDENCE

DRUG ABUSE 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.

OVERDOSAGE

OVERDOSAGE

Although rare, deaths may occur from overdosage with cyclobenzaprine hydrochloride.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION

For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets, USP is 5 mg three

times a day.

HOW SUPPLIED

HOW SUPPLIED

Cyclobenzaprine hydrochloride tablets, USP 5 mg are supplied as butterscotch yellow-colored, capsule-

shaped, film-coated convex tablets, debossed with "AN40" on one side and plain on the other side.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CYCLOBENZAPRINE HYDROCHLORIDE 
cyclobenzaprine hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69512-541
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)	CYCLOBENZAPRINE HYDROCHLORIDE	10 mg  in 10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow (Yellow (Butterscotch))	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	AN41
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69512-541-10	100 in 1 BOTTLE
1		10 mg in 1 CAPSULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078218	10/01/2015

Labeler - Alivio Medical Products, LLC (079670828)