ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Larken Laboratories Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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-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, 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 P

Product summary:

Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets, containing acetaminophen 325 mg, caffeine 30 mg and dihydrocodeine bitartrate 16 mg, are supplied in bottles of 100 tablets (NDC 68047-720-01). Tablets are white, capsule-shaped tablets debossed “LL 720” on one side and plain on the other side. 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. Store Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients/Caregivers ]. 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: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com 500412-09 Rev. 01/2021

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE- ACETAMINOPHEN,
CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLET
Larken Laboratories Inc.
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MEDICATION GUIDE
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 or call 911 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.
Talk to your healthcare provider about naloxone, a medicine for the
emergency treatment of an
opioid overdose.
•
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. Selling or giving away Acetaminophen,
Caffeine and
Dihydrocodeine Bitartrate Tablets is against the law.
•
Store Acetaminophen, Caffeine and Dihyd

Summary of Product characteristics

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE-
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLET
LARKEN LABORATORIES INC.
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ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLETS C-III
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, 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 DEPRESSION
SERIOUS, LIFE-THREATENING