tizanidine hydrochloride tizanidine hydrochloride capsule
1 INDICATIONS AND USAGE Tizanidine hydrochloride capsules are central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1) ] . Tizanidine hydrochloride capsules are central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important. (1)
jubilant cadista pharmaceuticals inc.
CAPSULE BLUE C 671
C 671 CAPSULE BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Tizanidine Hydrochloride capsules Tizanidine hydrochloride capsules are available in three strengths as two-piece hard gelatin capsules containing tizanidine hydrochloride USP 2.29 mg, 4.58 mg and 6.87 mg, equivalent to 2 mg, 4 mg and 6 mg tizanidine base. Tizanidine Hydrochloride capsules are supplied as: 2 mg: The capsules have blue opaque cap and white opaque body, size ‘4’ hard gelatin, printed radially in black ink with ‘C’ on the cap and ‘670’ on the body. Bottle of 30’s (child-resistant) NDC 59746-670-30 Bottle of 100’s (child-resistant) NDC 59746-670-01 Bottle of 150’s (child-resistant) NDC 59746-670-34 Bottle of 1000’s (ribbed-stock) NDC 59746-670-10 4 mg: The capsules have light blue opaque cap and body, size ‘3’ hard gelatin, printed radially in black ink with ‘C’ on the cap and ‘671’ on the body. Bottle of 30’s (child-resistant) NDC 59746-671-30 Bottle of 100’s (child-resistant) NDC 59746-671-01 Bottle of 150’s (child-resistant) NDC 59746-671-34 Bottle of 1000’s (ribbed-stock) NDC 59746-671-10 6 mg: The capsules have light blue opaque cap and white opaque body, size ‘2’ hard gelatin, printed radially in black ink with ‘C’ on the cap and ‘672’ on the body. Bottle of 30’s (child-resistant) NDC 59746-672-30 Bottle of 100’s (child-resistant) NDC 59746-672-01 Bottle of 150’s (child-resistant) NDC 59746-672-34 Bottle of 500’s (ribbed-stock) NDC 59746-672-05 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]. Dispense in a tight, light-resistant container [see USP]. Dispense in containers with child resistant closure.
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