ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Disponibbli minn:

Direct_Rx

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) Have not provided adequate analgesia, or are not expected to provide adequate analgesia, Have not been tolerated, or are not expected to be tolerated. Acetaminophen and codeine phosphate tablets are contraindicated for: All children younger than 12 years of age (see WARNINGS). Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS). Acetaminophen and codeine phosphate tablets are contraindicated in patients with: significant respiratory depression (see WARNINGS).

Sommarju tal-prodott:

Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/15 mg tablet contains acetaminophen 300 mg and codeine phosphate 15 mg. It is available as a round, white to off-white tablet debossed with “2” on one side and an [Boxed M] on the other side. Bottles of 100......................................... NDC 0406-0483-01 Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/30 mg tablet contains acetaminophen 300 mg and codeine phosphate 30 mg. It is available as a round, white to off-white tablet debossed with “3” on one side and an [Boxed M] on the other side. Bottles of 20............................................ NDC 0406-0484-20 Bottles of 30............................................ NDC 0406-0484-03 Bottles of 50............................................ NDC 0406-0484-50 Bottles of 100......................................... NDC 0406-0484-01 Bottles of 1000....................................... NDC 0406-0484-10 Unit Dose (10 x 10)............................... NDC 0406-0484-62 Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg. It is available as a round, white to off-white tablet debossed with “4” on one side and an [Boxed M] on the other side. Bottles of 100......................................... NDC 0406-0485-01 Bottles of 500......................................... NDC 0406-0485-05 Store acetaminophen and codeine phosphate tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Store acetaminophen and codeine phosphate tablets securely and dispose of properly (see PRECAUTIONS, INFORMATION FOR PATIENTS). Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and [Boxed M] are trademarks of a Mallinckrodt company. © 2020 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 08/2020 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20A08.pdf or by calling 1-800-778-7898 for alternate delivery options.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
Direct_Rx
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Medication Guide
Acetaminophen and Codeine Phosphate Tablets USP, CIII
(a seet' a min' oh fen and koe' deen fos' fate)
Acetaminophen and codeine phosphate tablets are:
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage mild to
moderate pain, when other pain treatments such as non-opioid pain
medicines do not treat your pain well
enough or you cannot tolerate them.
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your dose correctly
as prescribed, you are at risk for opioid addiction, abuse, and misuse
that can lead to death.
Important information about acetaminophen and codeine phosphate
tablets:
Get emergency help or call 911 right away if you take too many
acetaminophen and codeine phosphate
tablets (overdose). When you first start taking acetaminophen and
codeine phosphate tablets, when your dose
is changed, or if you take too much (overdose), serious or
life-threatening breathing problems that can lead to
death may occur. Talk to your healthcare provider about naloxone, a
medicine for the emergency treatment
of an opioid overdose.
Taking acetaminophen and codeine tablets with other opioid medicines,
benzodiazepines, alcohol, or other
central nervous system depressants (including street drugs) can cause
severe drowsiness, decreased
awareness, breathing problems, coma and death.
Never give anyone else your acetaminophen and codeine phosphate
tablets. They could die from taking it.
Selling or giving away acetaminophen and codeine phosphate tablets is
against the law.
Store acetaminophen and codeine phosphate tablets securely, out of
sight and reach of children, and in a
location not accessible by others, including visitors to the home.
Important Information Guiding Use in Pediatric Patients:
Do not give acetaminophen and codeine phosphate tablets to a child
younger than 12 years of age.
Do not give acetaminophen and codeine phosph

Karatteristiċi tal-prodott

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
DIRECT_RX
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and codeine phosphate tablets are supplied in tablet
form for oral
administration.
Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline
powder, is a non-opiate, non-salicylate analgesic and antipyretic. It
has the following
structural formula:
[Acetaminophen Chemical Structure]
Codeine phosphate,
7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a
narcotic analgesic
and antitussive. It has the following structural formula:
[Codeine Phosphate Chemical Structure]
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg)
contains:
Acetaminophen USP………………..…300 mg
Codeine Phosphate USP……………….15 mg
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg)
contains:
Acetaminophen USP……………..……300 mg
Codeine Phosphate USP……………….30 mg
Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg)
contains:
Acetaminophen USP……………..……300 mg
Codeine Phosphate USP……………….60 mg
In addition, each tablet contains the following inactive ingredients:
crospovidone,
magnesium stearate, microcrystalline cellulose, povidone,
pregelatinized starch, stearic
acid.
Mechanism of Action
Codeine is an opioid agonist relatively selective for the mu-opioid
receptor, but with a
much weaker affinity than morphine. The analgesic properties of
codeine have been
speculated to come from its conversion to morphine, although the exact
mechanism of
analgesic action remains unknown.
The precise mechanism of the analgesic properties of acetaminophen is
not established
but is thought to involve central actions.
Pharmacodynamics
Effects on the Central Nervous System
Codeine produces respiratory depression by direct action on brain stem
respiratory
centers. The respiratory depression involves a reduc