Label: CYCLOBENZAPRINE HYDROCHLORIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69512-541-10 - Packager: Alivio Medical Products, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated October 15, 2015
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- Official Label (Printer Friendly)
- DESCRIPTION
- DESCRIPTION
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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
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- CONTRAINDICATIONS
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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
- ADVERSE REACTIONS
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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
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride tabletProduct 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)