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The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows:
Oxycodone/paracetamol, sold under the brand name Percocet among others, [2] is a fixed-dose combination of the opioid oxycodone with paracetamol (acetaminophen), used to treat moderate to severe pain.
After a dose of conventional (immediate-release) oral oxycodone, the onset of action is 10 to 30 minutes, [11] [9] and peak plasma levels of the drug are attained within roughly 30 to 60 minutes; [11] [9] [74] in contrast, after a dose of OxyContin (an oral controlled-release formulation), peak plasma levels of oxycodone occur in about three ...
In the US, this information is overseen by the Center for Drug Research and Evaluation (CDER), a branch of the Food and Drug Administration (FDA). For prescription medications , the insert is technical , and provides information for medical professionals about how to prescribe the drug.
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Methylphenidate, sold under the brand names Ritalin (/ ˈ r ɪ t ə l ɪ n / RIT-ə-lin) and Concerta (/ k ə n ˈ s ɜːr t ə / kən-SUR-tə) among others, is a central nervous system (CNS) stimulant indicated in the pharmacotherapy of attention deficit hyperactivity disorder (ADHD) and narcolepsy.
EE/CPA is used as a combined birth control pill to prevent ovulation and pregnancy in women. [2] It is also approved and used to treat androgen-dependent conditions in women such as acne , seborrhea , hirsutism , female pattern hair loss , and hyperandrogenism due to polycystic ovary syndrome .
Adderall and Mydayis [11] are trade names [note 2] for a combination drug containing four salts of amphetamine.The mixture is composed of equal parts racemic amphetamine and dextroamphetamine, which produces a (3:1) ratio between dextroamphetamine and levoamphetamine, the two enantiomers of amphetamine. [13]