Prescription Drug Name:
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII Rx Only
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
codeine, with a peripherally acting analgesic, acetaminophen.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
to moderately severe pain.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
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.
or clinical course of patients with acute abdominal conditions.
use of this product is not recommended.
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
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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
constipation, abdominal pain, pruritus, rash, thrombocytopenia,
DRUG ABUSE AND DEPENDENCE
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
Schedule III controlled substance.
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
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
pinpoint pupils, depression of respiration, and loss of consciousness.
Convulsions may occur.
hepatic necrosis is the most serious adverse effect. Renal tubular necrosis,
hypoglycemic coma and thrombocytopenia may also occur.
nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory
evidence of hepatic toxicity may not be apparent until 48 to 72 hours
less than 10 grams, or fatalities with less than 15 grams.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
response of the patient.
|Codeine Phosphate||15 mg to 60 mg||360 mg|
|Acetaminophen||300 mg to 1000 mg||4000 mg|
number of tablets per 24 hours based upon the above dosage guidance. This
information should be conveyed in the prescription.
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.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Storage and Dispensing
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7
container as defined in the USP/NF.
Controlled Room Temperature].
PRINCIPAL DISPLAY PANEL 300mg/30mg 30 count
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4