Haloperidol 5 MG Oral Tablet
INDICATIONS AND USAGE Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.
Mylan Pharmaceuticals Inc.
ROUND ORANGE MYLAN 327
MYLAN 327 ROUND ORANGE
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HOW SUPPLIED
HALOPERIDOL Tablets, USP are available containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of
HALOPERIDOL, USP. The 0.5 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 351 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0351-01 bottles of 100 tablets NDC 0378-0351-10 bottles of 1000 tablets The 1 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 257 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0257-01 bottles of 100 tablets NDC 0378-0257-10 bottles of 1000 tablets The 2 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 214 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0214-01 bottles of 100 tablets NDC 0378-0214-10 bottles of 1000 tablets The 5 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 327 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0327-01 bottles of 100 tablets NDC 0378-0327-10 bottles of 1000 tablets The 10 mg tablets are light green, round, flat-faced, scored tablets debossed with MYLAN over 334 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0334-01 bottles of 100 tablets The 20 mg tablets are light blue, round, flat-faced, scored tablets debossed with MYLAN over 335 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0335-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75076829 Revised: 7/2020 MXI:HALO:R1
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