Tylenol

INDICATIONS AND USAGE

Regular Strength TYLENOL® Tablets, Extra Strength TYLENOL® Gelcaps, Geltabs, Caplets, or Tablets: temporarily relieves minor aches and pains due to:

  •     headache · muscular aches · backache · arthritis;
  •     the common cold · toothache · menstrual cramps;
  •     temporarily reduces fever.
Extra Strength TYLENOL® Adult Liquid: temporarily relieves minor aches and pains due to:
  •     headache · muscular aches · backache · arthritis;
  •     the common cold · toothache · menstrual cramps;
  •     reduces fever.
TYLENOL® Arthritis Pain Extended Release Geltabs/Caplets: temporarily relieves minor aches and pains due to:
  •     arthritis · the common cold · headache · toothache;
  •     muscular aches · backache · menstrual cramps.
TYLENOL® 8 Hour Extended Release Geltabs/Caplets: temporarily relieves minor aches and pains due to:
  •     muscular aches · backache · headache · toothache · the common cold;
  •     menstrual cramps · minor pain of arthritis;
  •     temporarily reduces fever.

ACETAMINOPHEN: Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/= 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. 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 postingestion. In adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N -acetylcysteine. For full prescribing information, refer to the N -acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N -acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach.

A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N -acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals. Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount was ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N -acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N -acetylcysteine should be initiated and continued for a full course of therapy. For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free.