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:

Teva Pharmaceuticals USA, Inc.

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 for: - All children younger than 12 years of age [see WARNINGS ]. - Post-operative 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 ].

Product summary:

Acetaminophen and codeine phosphate tablets USP (white, round, unscored): List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01 List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from moisture. PROTECT FROM LIGHT. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store acetaminophen and codeine phosphate tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients/Caregivers ]. Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. AT 7/2020

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Acetaminophen and Codeine
Phosphate (a seet' a min' oh fen
and koe' deen fos' fate) Tablets
USP, CIII
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 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 than

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
RX ONLY
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
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS
RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDICATION
GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST, AND
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
ACETAMINOPHEN AND C