tizanidine 4 MG as tizanidine hydrochloride 4.58 MG Oral Tablet

1 INDICATIONS AND USAGE Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important. ( 1 ) Tizanidine is indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1 )] .

Unichem Pharmaceuticals (USA), Inc.

FDA Reported Adverse Reactions
`[1] pain` `[2] drug ineffective` `[3] nausea` `[4] fatigue` `[5] toxicity to various agents` `[6] off label use` `[7] diarrhoea` `[8] death` `[9] headache` `[10] dyspnoea`

9 years ago

ROUND WHITE U 169

9 years ago

U 169 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING 16.2

TIZANIDINE Tablets

TIZANIDINE (

TIZANIDINE hydrochloride) tablets, USP are available as white to off-white, round, flat, bevel edged uncoated tablets containing 2 mg or 4 mg of

TIZANIDINE.

TIZANIDINE tablets USP, 2 mg are debossed with "U" and "168" on one side and bisecting score on other side. Bottles of 90: NDC 29300-168-19 Bottles of 150: NDC 29300-168-15 Bottles of 500: NDC 29300-168-05 Bottles of 1,000: NDC 29300-168-10

TIZANIDINE tablets USP, 4 mg are debossed with "U" and "169" on one side and quadrisecting score on other side. Bottles of 90: NDC 29300-169-19 Bottles of 150: NDC 29300-169-15 Bottles of 300: NDC 29300-169-03 Bottles of 500: NDC 29300-169-05 Bottles of 1,000: NDC 29300-169-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container [see USP].

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unichem pharmaceuticals (usa), inc.

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