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:

Cardinal Health 107, LLC

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) Acetaminophen and codeine phosphate tablets are contraindicated for: Acetaminophen and codeine phosphate tablets are contraindicated in patients with: Controlled Substance Acetaminophen and codeine phosphate tablets contain codeine. Codeine in combination with acetaminophen, is a Schedule III controlled substance. Abuse Acetaminophen and codeine phosphate tablets contain codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, a

Product summary:

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  on the other side. Overbagged with 10 tablets per bag, NDC 55154-7553-0 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  are trademarks of a Mallinckrodt company. © 2020 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Distributed By: Cardinal Health Dublin, OH 43017 LC5682190219 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Cardinal Health 107, LLC
----------
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 phosphate tablets to a child
younger th

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
CARDINAL HEALTH 107, LLC
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF
CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING
RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID
WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING
CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; 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).
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS):
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA)
HAS REQUIRED A REMS FOR THESE PRODUCTS (_SEE _WARNINGS). UNDER THE
REQUIREMENTS OF THE REMS, DRUG COMPANIES WITH APPROVED OPIOID
ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY
ENCOURAGED TO
•
•
•
•
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 _WARNI