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:

Proficient Rx LP

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] Acetaminophen and codeine phosphate tablets are contraindicated in patients with: Controlled Substance Acetaminophen and codeine phosphate tablet contains acetaminophen and codeine phosphate, a Schedule CII controlled substance. Abuse Acetaminophen and codeine phosphate tablet contains  codeine, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydrormorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Acetaminophen and Codeine Phosphate Tablets can be abused and is subject to

Product summary:

Acetaminophen and codeine phosphate tablets, USP are supplied as follows: 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.         Bottles of 15 NDC 63187-815-15  Bottles of 20                 NDC 63187-815-20          Bottles of 30                NDC 63187-815-30          Bottles of 60                NDC 63187-815-60 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 Repackaged by:  Proficient Rx LP. Thousand Oaks, CA 91320 Revised: 12/2016  LM 2126

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACETAMINOPHEN AND CODEINE PHOSPHATE- acetaminophen and codeine
phosphate tablet
Proficient Rx LP
----------
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 providerif you have a history
of:
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Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
PROFICIENT RX LP
----------
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 MORPHINE
RESPIRATORY DEPRES