haloperidol 0.5 mg

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.

aurobindo pharma limited

FDA Reported Adverse Reactions
`[1] off label use` `[2] drug ineffective` `[3] toxicity to various agents` `[4] drug interaction` `[5] product use in unapproved indication` `[6] completed suicide` `[7] acute kidney injury` `[8] death` `[9] drug abuse` `[10] diarrhoea`

8 months ago

ROUND WHITE HL 0 5

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 white to off-white, round uncoated tablets, debossed with “HL” above the score line on one side and “0.5” on other side. They are available as follows: Bottles of 100 tablets NDC 59651-789-01 Bottles of 1000 tablets NDC 59651-789-99 The 1 mg tablets are white to off-white, round uncoated tablets, debossed with “HL” and “1” separated by score line on one side and plain on other side. They are available as follows: Bottles of 100 tablets NDC 59651-790-01 Bottles of 1000 tablets NDC 59651-790-99 The 2 mg tablets are white to off-white, round uncoated tablets, debossed with “HL” and “2” separated by score line on one side and plain on other side. They are available as follows: Bottles of 100 tablets NDC 59651-791-01 Bottles of 1000 tablets NDC 59651-791-99 The 5 mg tablets are light yellow color, round uncoated tablets, debossed with “HL” and “5” separated by score line on one side and plain on other side. They are available as follows: Bottles of 100 tablets NDC 59651-792-01 Bottles of 1000 tablets NDC 59651-792-99 The 10 mg tablets are light green color, round uncoated tablets, debossed with “HL” and “10” separated by score line on one side and plain on other side. They are available as follows: Bottles of 100 tablets NDC 59651-793-01 Bottles of 1000 tablets NDC 59651-793-99 The 20 mg tablets are light blue color, round uncoated tablets, debossed with “HL” and “20” separated by score line on one side and plain on other side. They are available as follows: Bottles of 100 tablets NDC 59651-794-01 Bottles of 1000 tablets NDC 59651-794-99 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]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 11/2024

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