ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

CODEINE PHOSPHATE

Composition:

CODEINE PHOSPHATE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetaminophen and Codeine Phosphate Tablets, USP 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, USP for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Controlled Substance Acetaminophen and Codeine Phosphate Tablets, USP contain codeine. Codeine in combination with acetaminophen, is a Schedule III controlled substance. Abuse Acetaminophen and Codeine Phosphate Tablets, USP contain codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Acetaminophen and Codeine Phosphate Tablets, USP can be abused and is subject to misuse, addiction, and criminal diversi

Product summary:

Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg are white, round, tablets, debossed “RX ” over “562 ” on one side and “3 ” on the other side. Each tablet contains 300 mg of acetaminophen, USP and 30 mg of codeine phosphate, USP. They are supplied as follows: Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/60 mg are white, round, tablets, debossed “RX ” over “561 ” on one side and “4 ” on the other side. Each tablet contains 300 mg of acetaminophen, USP and 60 mg of codeine phosphate, USP. They are supplied as follows: Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Protect from light. Do not refrigerate. Do not freeze. Dispense in tight, light-resistant container as defined in the USP. Store Acetaminophen and Codeine Phosphate Tablets, USP securely and dispose of properly [see PRECAUTIONS/Information for Patients ]. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: CorePharma LLC Middlesex, NJ 08846 USA Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Sun Pharmaceutical Industries, Inc.
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Medication Guide
Acetaminophen (a seet’ a min’ oh fen) and Codeine Phosphate
(koe’ deen fos’ fate) Tablets, USP 300 mg/30
mg and 300 mg/60 mg, CIII
Acetaminophen and Codeine Phosphate Tablets, USP 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, USP:
•Get emergency help or call 911 right away if you take too much
Acetaminophen and Codeine Phosphate
Tablets, USP (overdose). When you first start taking Acetaminophen and
Codeine Phosphate Tablets, USP,
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 phosphate tablets, USP 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, USP. They could die from
taking it. Selling or giving away Acetaminophen and Codeine Phosphate
Tablets, USP is against the law.
•Store Acetaminophen and Codeine Phosphate Tablets, USP 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 ye

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
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ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII
(300 MG/30 MG, 300 MG/60 MG)
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, USP 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, USP, 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, USP. MONITOR FOR
RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF ACETAMINOPHEN
AND
CODEINE PHOSPHATE TABLETS, USP OR FOLLOWING A DOSE INCREASE [SEE
WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS,
USP, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL O