ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 in: Patients with significant respiratory depression (see WARNINGS). Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see WARNINGS). Postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy (see WARNINGS). Patients with known or

Product summary:

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 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 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 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. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and M are trademarks of a Mallinckrodt company. © 2016 Mallinckrodt. Mallinckrodt Inc. Hazelwood, MO 63042 USA Rev 11/2016 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
RedPharm Drug
----------
MEDICATION GUIDE
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 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.
Acetaminophen and codeine phosphate tablets can cause severe
drowsiness, breathing problems
(respiratory depression), coma and death when taken with
benzodiazepines or other medicines that
depress consciousness.
Never give anyone else your acetaminophen and codeine phosphate
tablets. They could die from taking it.
Store acetaminophen and codeine phosphate tablets away from children
and in a safe place to prevent
stealing or abuse. Selling or giving away acetaminophen and codeine
phosphate tablets is against the law.
Do not take acetaminophen and codeine phosphate tablets if you have:
severe asthma, trouble breathing, or other lung problems.
a bowel blockage or narrowing of the stomach or intestines.
previously had an allergic reaction to codeine or acetaminophen.
Before taking acetaminophen and codeine phosphate tablets, tell your
healthcare provider if you have a
history of:
head injury, seizures
prob

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
REDPHARM DRUG
----------
ACETAMINOPHEN W/COD
BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO
MORPHINE;HEPATOTOXICITY; CYTOCHROME P450 2D6 INTERACTION; and RISKS
FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
Acetaminophen and codeine phosphate tablets expose patients and other
users to the risks of
opioid addiction, abuse, and misuse, which can lead to overdose and
death. Assess each patient’s
risk prior to prescribing acetaminophen and codeine phosphate tablets,
and monitor all patients
regularly for the development of these behaviors and conditions (see
WARNINGS).
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of acetaminophen
and codeine phosphate tablets. Monitor for respiratory depression,
especially during initiation of
acetaminophen and codeine phosphate tablets or following a dose
increase (see WARNINGS).
Accidental Ingestion
Accidental ingestion of acetaminophen and codeine phosphate tablets,
especially by children, can
result in a fatal overdose of acetaminophen and codeine phosphate
tablets (see WARNINGS).
Neonatal Opioid Withdrawal Syndrome
Prolonged use of acetaminophen and codeine phosphate tablets during
pregnancy can result in
neonatal opioid withdrawal syndrome, which may be life-threatening if
not recognized and treated,
and requires management according to protocols developed by
neonatology experts. If opioid use
is required for a prolonged period in a pregnant woman, advise the
patient of the risk of neonatal
opioid withdrawal syndrome and ensure that appropriate treatment will
be available (see
WARNINGS).
Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Respiratory depression and death have occurred in children who
received