ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), DIHYDROCODEINE BITARTRATE (UNII: 8LXS95BSA9) (DIHYDROCODEINE - UNII:N9I9HDB855)

Prieinama:

Atland Pharmaceuticals, LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets are indicated for the management of pain severe enough to require an opioid analgesic 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, Caffeine, and Dihydrocodeine Bitartrate Tablets for use in patients for whom alternative  treatment options [e.g., non-opioidanalgesics] - 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, Caffeine and Dihydrocodeine Bitartrate Tablets are contraindicated for: All - children younger than 12 years of age [see  WARNINGS and PRECAUTIONS ] - Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see  WARNINGS and PRECAU

Produkto santrauka:

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets, containing acetaminophen 325 mg, caffeine 30 mg and dihydrocodeine bitartrate 16 mg, are supplied in bottles of 30 tablets (NDC 71993-300-30). Tablets are white, capsule-shaped tablets debossed “LL 720” on one side and plain on the other side. Storage and Handling Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container  with a child-resistant  closure. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Rx Only Distributed by: Atland Pharmaceuticals, LLC Sylacauga, AL 35150 ATL.300.99   Rev. 01/2020

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE- ACETAMINOPHEN,
CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLET
Atland Pharmaceuticals, LLC
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SPL MEDGUIDE
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, CIII
Acetaminophen (a seet” a min’ oh fen), Caffeine (ka feen’) and
Dihydrocodeine Bitartrate (dye hye” droe
koe’ deen bye tar’ trate)
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage
moderate to moderately severe 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, Caffeine and Dihydrocodeine
Bitartrate Tablets:
•
Get emergency help right away if you take too much Acetaminophen,
Caffeine and
Dihydrocodeine Bitartrate Tablets (overdose). When you first start
taking Acetaminophen,
Caffeine and Dihydrocodeine Bitartrate 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.
•
Taking Acetaminophen, Caffeine and Dihydrocodeine Bitartrate 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, Caffeine and Dihydrocodeine
Bitartrate Tablets.
They could die from taking it. Store Acetaminophen, Caffeine and
Dihydrocodeine Bitartrate
Tablets away from children and in a safe place to prevent stealing or
abuse. Selling or giving away
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets is
against the law.
Important Information Guiding

Prekės savybės

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE- ACETAMINOPHEN,
CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLET
ATLAND PHARMACEUTICALS, LLC
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ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLETS 325 MG/
30 MG/ 16 MG - CIII
BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATING RESPIRATORY
DEPRESSION;ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF
CODEINE AND OTHER RISK FACTORS FOR LIFE-THEREATING RESPIRATORY
DEPRSSIONS IN CHILDREN; NEONATAL OPIOID WITHDRAWL 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, CAFFEINE, AND DIHYDROCODEINE BITARTRATE 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, CAFFEINE, AND
DIHYDROCODEINE BITARTRATE 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 DE