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 treatment of spasticity. ( 1 ) Tizanidine is indicated for the treatment of spasticity in adults.

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 16.1 How Supplied Tizanidine Tablets Tizanidine 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 white to off white, round, flat, beveledged uncoated tablet with "U" on one side and "168" debossed 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 1000: NDC 29300-168-10 Tizanidine tablets USP, 4 mg white to off white, round, flat, beveledged uncoated tablet with "U" on one side and "169" debossed 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 1000: NDC 29300-169-10 16.2 Storage and Handling Store at 20° - 25°C (68° - 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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