ACETAMINOPHEN AND CODEINE PHOSPHATE solution

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:

Morton Grove Pharmaceuticals, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 120 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetaminophen and Codeine Phosphate Oral Solution is 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 Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Acetaminophen and Codeine Phosphate Oral Solution is 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 Oral Solution is contraindicated in patients with: - Significant respiratory depre

Product summary:

Acetaminophen and Codeine Phosphate Oral Solution USP is an orange colored, cherry-flavored liquid available in Pint (473 mL) bottles (NDC 60432-245-16). SHAKE WELL BEFORE USING. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistance closure. Store Acetaminophen and Codeine Phosphate Oral Solution securely and dispose of properly [see PRECAUTIONS/ Information for Patients ].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
Morton Grove Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Acetaminophen and Codeine Phosphate
(a seet' a min' oh fen and koe' deen fos' fate) Oral Solution, CV
Acetaminophen and Codeine Phosphate Oral Solution is:
•
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 Oral
Solution:
•
Get emergency help right away if you take too much Acetaminophen and
Codeine Phosphate Oral
Solution (overdose). When you first start taking Acetaminophen and
Codeine Phosphate Oral
Solution, 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.
•
Taking Acetaminophen and Codeine Phosphate Oral Solution 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 Oral
Solution. They could die
from taking it. Selling or giving away Acetaminophen and Codeine
Phosphate Oral Solution is against
the law.
•
Store Acetaminophen and Codeine Phosphate Oral Solution 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 Oral Solution to a
child younger than 12 years of
age.
•
Do not give Acetaminophen and Codeine Phosphat

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USP
120 MG/12 MG PER 5 ML
CV
Rx only
WARNING: RISK OF MEDICATION ERRORS; 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; DEATH RELATED TO ULTRA-RAPID METABOLISM
OF CODEINE TO MORPHINE; INTERACTIONS WITH DRUGS AFFECTING
CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
RISK OF MEDICATION ERRORS
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
ACETAMINOPHEN AND
CODEINE PHOSPHATE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION
BETWEEN MG AND ML, AND
OTHER CODEINE CONTAINING ORAL PRODUCTS OF DIFFERENT CONCENTRATIONS CAN
RESULT IN ACCIDENTAL
OVERDOSE AND DEATH [SEE WARNINGS, DOSAGE AND ADMINISTRATION].
ADDICTION, ABUSE, AND MISUSE
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION EXPOSES 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
ORAL SOLUTION, 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
DO ALL THE FOLLOWING:
● COMPLETE A REMS-COMPLI