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NDC 69292-0586-01

Haloperidol 5 mg/1 TABLET

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NDC
69292-0586-01
Generic Name
Haloperidol
Brand Name
Haloperidol
Strength
5 mg/1
Dosage Form
TABLET
Route
ORAL
Package Size
Labeler
Amici Pharmaceuticals, LLC

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP 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, USP are also effective…

Important Warnings

WARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). Cardiovascular Effects Cases of sudden death, QT-prolongation, and Torsades de pointes hav…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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