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:

NCS HealthCare of KY, LLC dba Vangard Labs

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 in patients with: - Patients with significant respiratory depression [see WARNINGS].  - Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS].  - Postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [see WARNINGS]

Product summary:

Acetaminophen and codeine phosphate tablets, USP are supplied as follows: 300 mg/15 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U35” on one side and plain on the other side.           300 mg/30 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U36” on one side and plain on the other side.          Blistercards of 30                 NDC 0615-8102-39           300 mg/60 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U37” on one side and plain on the other side.         Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep this and all medication out of the reach of children. Protect from moisture. Dispense in a tight, light-resistant container as described in the USP.  PROTECT FROM LIGHT Dispense with Medication Guide availableat www.aurobindousa.com/product-medication-guides Manufactured by:  Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for:  Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Revised: 12/2016  LM 2126

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
MEDICATION GUIDE
Acetaminophenand Codeine Phosphate Tablets, USP CIII
ass-cet-ah-MEE-noe-fenwith KOE-deen FOSS-fate
Acetaminophen and Codeine PhosphateTablets 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 codeinephosphate
tablets:
•
Get emergency help right away if you take too much 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.
•
Acetaminophen and Codeine Phosphate Tablets can cause severe
drowsiness, breathing problems
(respiratory depression), coma and death when taken with
benzodiazepines or other medicines that
depress consciousness.
•
Never give anyone else your acetaminophen and codeine phosphate
tablets. They could die from
taking it. Store acetaminophen and codeine phosphate tablets away from
children and in a safe
place to prevent stealing or abuse. Selling or giving away
acetaminophen and codeine phosphate
tablets are against the law.
Do not take Acetaminophen and Codeine Phosphate Tablets ifyou have:
•severe asthma, trouble breathing, or other lung problems.
•a bowel blockage or narrowing of the stomach or intestines.
•previously had an allergic reaction to codeine or acetaminophen.
Before taking acetaminophen and codeine phosphatetablets, tell your
healthcare provideri

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; DEATH RELATED TO ULTRA-RAPID METABOLISM
OF CODEINE TO MORPHINE; HEPATOTOXICITY; CYTOCHROME P450 2D6
INTERACTION; 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].
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 EVEN ONE DOSE OF ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF
ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLETS [SEE WARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS DURING
PREGNANCY CAN
RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE
LIFE-THREATENING IF NOT
RECOGNIZED AND TREATED, AND REQUIRES MANAGEMENT ACCORDING TO PROTOCOLS
DEVELOPED BY
NEONATOLOGY EXPERTS. IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD
IN A PREGNANT WOMAN,
ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME
AND ENSURE THAT
APPROPRIATE TREATMENT WILL BE AVAILABLE [SEE WARNINGS].
DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO M