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Tylenol

"July 8, 2010 -- The recall of Tylenol and other over-the-counter medicines has grown once again, with Tylenol maker McNeil PCC Inc. today announcing the recall of 21 lots of medicines as a precautionary measure.

Today's recall includes "...

Tylenol

INDICATIONS

USES

Temporary relieves minor aches and pains due to:

  • minor pain of arthritis
  • backache
  • the common cold
  • muscular aches
  • premenstural and menstrual cramps
  • headache
  • toothache
  • temporarily reduces fever

DOSAGE AND ADMINISTRATION

DOSAGE RANGE

a. Administration

TYLENOL (acetaminophen) ® acetaminophen products are only administered orally. They are available in a variety of convenient dosage forms as listed in Tables 2 and 3. For ease of administration for young children, Infants' TYLENOL (acetaminophen) Concentrated Drops are more concentrated than the Children's TYLENOL (acetaminophen) liquid formulations. Infants' TYLENOL (acetaminophen) Concentrated Drops labeling instructs consumers to use only the dropper enclosed in the carton to dose the product and not to use any other dosing device with the product, such as spoons, droppers, or cups that come with other medicines. The labeling on Children's TYLENOL (acetaminophen) liquid formulations instructs consumers to use only the measuring cup enclosed in the package to dose the product and not to use any other dosing device, such as kitchen teaspoons, droppers, or cups that come with other medicines. TYLENOL® (acetaminophen) Arthritis Extended Relief Caplets should not be crushed, chewed, or dissolved in a liquid.

b. Adult Dosage

For adults and children 12 years of age and older, the recommended dose of acetaminophen is 650 to 1000 mg every 4 to 6 hours as needed, not to exceed 4000 mg in 24 hours (Table 2). For extended-release acetaminophen, the dose is 1300 mg every 8 hours as needed, not to exceed 3900 mg in 24 hours. Some adult products (Extra Strength TYLENOL (acetaminophen) , TYLENOL (acetaminophen) Arthritis Extended Relief Formula) are not intended for use in children under 12 years of age.

c. Pediatric Dosage

For children under 12 years of age, the recommended dose of acetaminophen is 10 to 15 mg/kg every 4 to 6 hours,47 not to exceed five doses (50-75 mg/kg) in 24 hours (Table 3).

Age-Related Dosing Schedule

The age-related schedule is based on standard age divisions proposed by the United States Food and Drug Administration (FDA) and used in the development of an acetaminophen dosing schedule.47

TABLE 4. Recommended pediatric dosing of acetaminophen by weight and age (adapted from reference 47, with permission)*

Weight Agea doseb (mg) Single Recommended
daily dose (mg)
lb kg
6-11 2.0 - 5.4 0-3 monthsc 40 200
12 -17 5.5 - 7.9 4-11 months 80 400
18 -23 8.0 - 10.9 12 - 23 months 120 600
24-35 11.0 - 15.9 2-3 years 160 800
36-47 16.0 - 21.9 4-5 years 240 1200
48-59 22.0 -26.9 6-8 years 320 1600
60-71 27.0 - 31.9 9-10 years 400 2000
72-95 32.0 -43.9 11 years 480 2400
* Refer to package label for more specific information related to dosing.
a For adults and children 12 years of age and older see Table 2.
b Doses may be repeated every 4 hours but not more than five times daily
c Data not available to define appropriate adjustments, if any, needed for the immediate neonatal period. Use of antipyretics in the immediate neonatal period is extremely limited.

Weight-Related Dosing Schedule

This weight-related dosing schedule was developed and recommended by McNeil Consumer Healthcare when dosing by weight. The weight-related schedule is based on weight ranges that are consistent with the use of a standard 80-mg dosage unit.47 Using this method, the weight-related dosage schedule provides a dose of 10 to 15 mg/kg body weight for a single dose. The weight-related schedule most closely approximates this dose, so that when possible, consumers should be instructed to use weight to calculate dose; otherwise, age may be used (Table 4).

The label for Regular Strength TYLENOL® acetaminophen products recommends that children 6 to 11 years old take 325 mg every 4 to 6 hours, not to exceed five doses in 24 hours.

d. Use of Recommended Doses for Longer Than 10 Days

Clinical studies have evaluated the use of acetaminophen in adult patients with osteoarthritis of the knee at recommended doses of 4000 mg/d for up to 4 weeks.48,49 Williams and colleagues50 evaluated the use of acetaminophen in doses up to 2600 mg/d for up to 2 years. In these studies, acetaminophen was well tolerated.

The package label for adult TYLENOL® acetaminophen products instructs adults not to take TYLENOL (acetaminophen) for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. The package label for Children's TYLENOL (acetaminophen) products instructs parents not to administer TYLENOL (acetaminophen) to children for pain for more than 5 days or for fever for more than 3 days unless directed by a doctor. As with all over-the-counter (OTC) analgesics, this warning is necessary so that patients and parents will seek appropriate medical evaluation of their condition if it persists beyond these time periods.

e. Alternate/Concomitant Dosing

Concomitant or alternate dosing with more than one antipyretic agent is not recommended. There are no studies to support alternate dosing of acetaminophen and ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs). Studies have demonstrated that single-dose concurrent administration of aspirin and acetaminophen produced a more prolonged temperature decrement than when either antipyretic was given alone.51,52

f. Recommended Storage Conditions

Storage requirements for all TYLENOL® acetaminophen drops, liquids, and solid formulations are as follows: store at room temperature. It is recommended that high humidity and excessive heat (ie, ≥ 40°C [104°F]) be avoided for the gelatin-coated formulations (eg, gelcaps, geltabs). Freezing of the liquid or suspension formulations should be avoided.

g. Expiration Dating Periods for Commercially Available Products

Under room temperature storage conditions, TYLENOL® acetaminophen solid formulations are generally stable for 3 years and liquid formulations are generally stable for 2 years from the date of manufacture. Refer to product package for specific expiration date.

HOW SUPPLIED

No information provided

References

47. Temple AR. Pediatric dosing of acetaminophen. Pediatr Pharmacol. 1983;3:321-327.

48. Amadio P, Cummings DM. Evaluation of acetaminophen in the management of osteoarthritis of the knee. Curr Ther Res. 1983;34:59-66.

49. Bradley J D, Brandt KD, Katz BP, Kalasinski LA, Ryan SI. Comparison of an anti-inflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. N Engl J Med. 1991;325: 87-91.

50. Williams HJ, Ward JR, Egger MJ, et al. Comparison of naproxen and acetaminophen in a two-year study of treatment of osteoarthritis of the knee. Arthritis Rheum. 1993;36:1196-1206.

51. Simila S, Keinanen S, Kouvalainen K. Oral antipyretic therapy: evaluation of benorylate, an ester of acetyl-salicylic acid and paracetamol. Eur J Pediatr. 1975;121:15-20.

52. Steele RW, Young FH, Bass JW, Shirkey HC. Oral antipyretic therapy: evaluation of aspirin-acetaminophen combination. Am J Dis Child. 1972;123:204-206.

FDA rev date:

Last reviewed on RxList: 11/7/2007
This monograph has been modified to include the generic and brand name in many instances.

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