OTHER INFORMATION
Regular Strength TYLENOLŪ Tablets
- do not use if carton is opened or red neck wrap or foil inner seal imprinted with "Safety SealŪ" is broken
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store between 20-25°C (68-77°F)
Extra Strength TYLENOLŪ Gelcaps, Geltabs, Caplets or Tablets
- do not use if carton is opened or red neck wrap or foil inner seal imprinted with "Safety SealŪ" is broken
-
store between 20-25°C (68-77°F) (tablet and caplet)
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store between 20-25°C (68-77°F); avoid high humidity and excessive heat 40°C (104°F). (Gelcap and Geltab)
Extra Strength TYLENOLŪ Adult Liquid
- do not use if carton is opened, or if bottle wrap or foil inner seal imprinted "Safety SealŪ" is broken or missing.
-
store between 20-25°C (68-77°F)
TYLENOLŪ Arthritis Pain Release Geltabs/Caplets and TYLENOLŪ 8 Hour Extended Release Geltabs/Caplets
- do not use if carton is opened or red neck wrap or foil inner seal with "Safety SealŪ" is broken
-
store at 20-25°C (68-77°F)
-
avoid excessive heat at 40°C (104°F)
PROFESSIONAL INFORMATION:
OVERDOSAGE INFORMATION FOR ALL ADULT TYLENOL PRODUCTS
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, (1-800-525-6115). Our adult TylenolŪ combination products contain active ingredients in addition to acetaminophen. The following is basic overdose information regarding those ingredients. CHLORPHENIRAMINE: Chlorpheniramine toxicity should be treated as you would an anthihistamine/anticholinergic overdose and is likely to be present within a few hours after acute ingestion.
DEXTROMETHORHPHAN: Acute dextromethorphan overdose usually does not result in serious signs and symptoms unless massive amounts have been ingested. Signs and symptoms of a substantial overdose may include nausea and vomiting, visual disturbances, CNS disturbances and urinary retention.
DIPHENHYDRAMINE: Diphenhydramine toxicity should be treated as you would an antihistamine/anticholinergic overdose and is likely to be present within a few hours after acute ingestion.
DOXYLAMINE: Doxylamine toxicity should be treated as you would an antihistamine/anticholinergic overdose and is likely to be present within a few hours after acute ingestion.
GUAIFENESIN: Guaifenesin should be treated as a nontoxic ingestion.
PAMABROM: Acute overexposure of diuretics is primarily associated with fluid and electrolyte loss. Fluid loss should be treated with the appropriate intravenous and/or oral fluids. PSEUDOEPHEDRINE: Symptoms from pseudoephedrine overdose consist most often of mild anxiety, tachycardia and/or mild hypertension. Symptoms usually appear within 4 to 8 hours of ingestion and are transient, usually requiring no treatment.
For additional emergency information, please contact your local poison control center. 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 usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Healthcare professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.
INACTIVE INGREDIENTS
Regular Strength TYLENOLŪ Tablets: cellulose, corn starch, magnesium stearate, sodium starch glycolate.
Extra Strength TYLENOLŪ Tablets: cellulose, corn starch, magnesium stearate, sodium starch glycolate. Caplets: cellulose, corn starch, FD&C Red #40, hypromellose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide. Gelcaps: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, D&C Yellow #10, edetate calcium disodium, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hypromellose, magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide. Geltabs: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, D&C Yellow #10, edetate calcium disodium, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, hypromellose, magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.
Extra Strength TYLENOLŪ Adult Liquid: citric acid, corn syrup, D&C Red #33, FD&C Red #40, flavor, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol
TYLENOLŪ Arthritis Pain Extended Relief Caplets: corn starch, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin. Geltabs: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, edetate, calcium disodium, FD&C Blue #1, FD&C Blue #2, gelatin, hydroxyethyl cellulose, hypromellose, magnesium stearate, methylparaben, povidone, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.
Tylenol 8 Hour Extended Release Caplets: corn starch, D&C Yellow #10, FD&C Red #40, FD&C Yellow #6, hydroxyethyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, powdered cellulose, pregelantinized starch, sodium starch glycolate, sucralose, talc, titanium dioxide. Geltabs: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, edetate calcium disodium, FD & C Blue #1, FD & C Blue #2, FD & C Red #40, gelatin, hydroxyethyl cellulose, hypromellose, magnesium stearate, methylparaben, povidone, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide
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