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:

NuCare 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 phos

Product summary:

Acetaminophen and Codeine Phosphate Oral Solution USP (orange-yellow color, cherry flavor) is supplied in the following oral dosage forms: NDC 66267-997-04 Bottles of 4 oz

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NuCare Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
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. Store acetaminophen and codeine phosphate oral
solution away from children and
in a safe place to prevent stealing or abuse. Selling or giving away
acetaminophen and codeine
phosphate oral solution is against the law.
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 phosphate oral solution to a
child younger than 18 years
of age after surgery to remove the tonsils and/or adenoids.
•
Avoid giving

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
NUCARE PHARMACEUTICALS,INC.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION USP CV
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE;
LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;
ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR
LIFE -THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL
OPIOD 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].
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION. MONITOR FOR
RESPIRATORY DEPRESSION,
ESPECIALLY DURING INITIATION OF ACETAMINOPHEN AND CODEINE PHOSPHATE
ORAL SOLUTION OR
FOLLOWING A DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL
SOLUTION, ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF ACETAMINOPHEN AND CODEINE
PHOSPHATE ORAL
SOLUTION [SEE WARNINGS].
ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR