ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Preferred Pharmaceuticals, Inc.

INN (Jina la Kimataifa):

ACETAMINOPHEN

Tungo:

ACETAMINOPHEN 300 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 for: Acetaminophen and codeine phosphate tablets are contraindicated in patients with:  Controlled Substance Acetaminophen and codeine phosphate tablets contain codeine. Codeine in combination with acetaminophen, is a Schedule III controlled substance. Abuse Acetaminophen and codeine phosphate tablets contain codeine, a sub

Bidhaa muhtasari:

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. Bottle of 15 - 68788-9229-1 Bottle of 20 - 68788-9229-2 Bottle of 30 - 68788-9229-3 Bottle of 60 - 68788-9229-6 Bottle of 90 - 68788-9229-9 300 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. Bottle of 15 - 68788-9300-1 Bottle of 20 - 68788-9300-2 Bottle of 30 - 68788-9300-3 Bottle of 60 - 68788-9300-6 Bottle of 90 - 68788-9300-9 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store acetaminophen and codeine phosphate tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients ]. 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 available at https://www.aurobindousa.com/medication-guides /  Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised:08/2020

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

Preferred Pharmaceuticals, Inc.
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Medication Guide
MEDICATION GUIDE
Acetaminophen and Codeine Phosphate Tablets(ass-cet-ah-MEE-noe-fen
with KOE-deen FOSS-fate), USP
CIII
Acetaminophen and Codeine Phosphate Tablets 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:
•
Get emergency help or call 911 right away if you take too much
acetaminophen and codeine phosphate
tablets (overdose). When you first start taking acetaminophen and
codeine 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. Talk to your healthcare provider about
naloxone, a medicine for the
emergency treatment of an opioid overdose.
•
Taking acetaminophen and codeine tablets 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. They could die from taking
it. Selling or giving away acetaminophen and codeine phosphate tablets
are against the law.
•
Store acetaminophen and codeine phosphate tablets 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 years of age.
•
Do not give acetaminophen and codeine phosphate tablets to a chil

Tabia za bidhaa

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
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 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].
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
• COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
• COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION,
ON
SAFE USE, SERIOUS RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS,
• EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF
READING
THE MEDICATION GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST,
AND
• CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF ACETAMINO