ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only

DESCRIPTION

id: 29b5ceed-e104-27cf-e054-00144ff8d46c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4’‑hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Codeine phosphate, 7,8‑didehydro‑4,5α‑epoxy‑3‑methoxy‑17‑methylmorphinan‑6α‑ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: Each tablet contains: Acetaminophen………………………300 mg Codeine Phosphate…………………..15 mg (Warning: May be habit forming) OR Acetaminophen………………………300 mg Codeine Phosphate………………….. 30 mg (Warning: May be habit forming) OR Acetaminophen………………………300 mg Codeine Phosphate………………….. 60 mg (Warning: May be habit forming) In addition, each tablet contains the following inactive ingredients: Corn Starch, Colloidal Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, and Microcrystalline Cellulose. The 300 mg/60 mg strength tablets also contain Crospovidone, Povidone, Pregelatinized Starch, and Stearic Acid.
(Teva Pharmaceuticals). In addition each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium metabisulfite, sodium starch glycolate and stearic acid.
(Vintage Pharmaceuticals)

CLINICAL PHARMACOLOGY

id: 29b3ab8c-00d9-3e92-e054-00144ff88e88
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

This product combines the analgesic effects of a centrally acting analgesic,
codeine, with a peripherally acting analgesic, acetaminophen.

INDICATIONS AND USAGE

id: 29b3ab8c-00db-3e92-e054-00144ff88e88
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Acetaminophen and codeine phosphate tablets are indicated for the relief of mild
to moderately severe pain.

CONTRAINDICATIONS

id: 29b3ab8c-00dc-3e92-e054-00144ff88e88
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

WARNINGS

id: 29b3ab8c-00dd-3e92-e054-00144ff88e88
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

In the presence of head injury or other intracranial lesions, the
respiratory depressant effects of codeine and other narcotics may be markedly
enhanced, as well as their capacity for elevating cerebrospinal fluid pressure.
Narcotics also produce other CNS depressant effects, such as drowsiness, that
may further obscure the clinical course of the patients with head injuries. Codeine or other narcotics may obscure signs on which to judge the diagnosis
or clinical course of patients with acute abdominal conditions. Codeine is habit-forming and potentially abusable. Consequently, the extended
use of this product is not recommended. Alcohol Information Chronic heavy alcohol abusers may be at increased risk of liver
toxicity from excessive acetaminophen use, although reports of this event are
rare. Reports almost invariably involve cases of severe chronic alcoholics and
the dosages of acetaminophen most often exceed recommended doses and often
involve substantial overdose. Professionals should alert their patients who
regularly consume large amounts of alcohol not to exceed recommended doses of
acetaminophen

ADVERSE REACTIONS

id: 29b3ab8c-00e7-3e92-e054-00144ff88e88
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The most frequently reported adverse reactions are drowsiness,
lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting.
These effects seem to be more prominent in ambulatory than in non-ambulatory
patients, and some of these adverse reactions may be alleviated if the patient
lies down. Other adverse reactions include allergic reactions, euphoria, dysphoria,
constipation, abdominal pain, pruritus, rash, thrombocytopenia,
agranulocytosis. At higher doses codeine has most of the disadvantages of morphine including
respiratory depression.

DRUG ABUSE AND DEPENDENCE

id: 29b3ab8c-00e8-3e92-e054-00144ff88e88
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

Controlled Substance Acetaminophen and codeine phosphate tablets are classified as a
Schedule III controlled substance. Abuse and Dependence Codeine can produce drug dependence of the morphine type and,
therefore, has the potential for being abused. Psychological dependence,
physical dependence, and tolerance may develop upon repeated administration and
it should be prescribed and administered with the same degree of caution
appropriate to the use of other oral narcotic medications

OVERDOSAGE

id: 29b3ab8c-00e9-3e92-e054-00144ff88e88
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Following an acute overdosage, toxicity may result from codeine
or acetaminophen. Signs and Symptoms Codeine Toxicity from codeine poisoning includes the opioid triad of:
pinpoint pupils, depression of respiration, and loss of consciousness.
Convulsions may occur. Acetaminophen In acetaminophen overdosage: dose-dependent, potentially fatal
hepatic necrosis is the most serious adverse effect. Renal tubular necrosis,
hypoglycemic coma and thrombocytopenia may also occur. Early symptoms following a potentially hepatotoxic overdose may include:
nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory
evidence of hepatic toxicity may not be apparent until 48 to 72 hours
post-ingestion. In adults, hepatic toxicity has rarely been reported with acute overdoses of
less than 10 grams, or fatalities with less than 15 grams.

DOSAGE AND ADMINISTRATION

id: 29b3ab8c-00eb-3e92-e054-00144ff88e88
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Dosage should be adjusted according to severity of pain and
response of the patient. The usual adult dosage is:

	Single Doses (range)	Maximum 24 Hour Dose
Codeine Phosphate	15 mg to 60 mg	360 mg
Acetaminophen	300 mg to 1000 mg	4000 mg

The usual dose of codeine phosphate in
children is 0.5 mg/kg. Doses may be repeated up to every 4 hours. The prescriber must determine the number of tablets per dose, and the maximum
number of tablets per 24 hours based upon the above dosage guidance. This
information should be conveyed in the prescription. It should be kept in mind, however, that tolerance to codeine can develop
with continued use and that the incidence of untoward effects is dose related.
Adult doses of codeine higher than 60 mg fail to give commensurate relief of
pain but merely prolong analgesia and are associated with an appreciably
increased incidence of undesirable side effects. Equivalently high doses in
children would have similar effects.

HOW SUPPLIED

id: 29b63d40-07cc-3b3e-e054-00144ff8d46c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Acetaminophen and Codeine Phosphate Tablets 300 mg/30 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed “2064” and “V” on one side and debossed “3” on the reverse side. They are supplied in bottles of 30, 50, 60, 90, 100, 120, 180, 500 and 1000. Acetaminophen and Codeine Phosphate Tablets 300 mg/60 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed “2065” and “V” on one side and debossed “4” on the reverse side. They are supplied in bottles of 100, 500 and 1000.

Storage and Dispensing

id: 29b3ab8c-00ed-3e92-e054-00144ff88e88
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

Dispense in a tight, light resistant
container as defined in the USP/NF. Store at 20° to 25°C (68° to 77°F) [see USP
Controlled Room Temperature].

PRINCIPAL DISPLAY PANEL 300mg/30mg 30 count

id: 29b5ceed-e109-27cf-e054-00144ff8d46c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4