Each Extra Strength TYLENOL® PM Caplet, Geltab or Gelcap contains acetaminophen 500 mg and diphenhydramine HCl 25 mg.
Extra Strength TYLENOL® PM Caplets , Geltabs and Gelcaps contain a clinically proven analgesic-antipyretic and an antihistamine. Maximum allowable non-prescription levels of acetaminophen and diphenhydramine provide temporary relief of occasional headaches and minor aches and pains accompanying sleeplessness. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin containing products. Acetaminophen produces analgesia by elevation of the pain threshold. Diphenhydramine HCl is an antihistamine with sedative properties.
Extra Strength TYLENOL® PM Caplets , Geltabs and Gelcaps: For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Adults and children 12 years of age and older: Take 2 caplets, geltabs or gelcaps at bedtime or as directed by a doctor. Children under 12 years of age: Do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems.
If a rare sensitivity reaction occurs, the drug should be discontinued.
Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
Do not use if carton is opened or neck wrap or foil inner seal imprinted with "Safety Seal®" is broken. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not take for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists, or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. Avoid alcoholic beverages while taking this product. Do not take this product if your are taking sedatives or tranquilizers without first consulting your doctor.
Do not exceed recommended dose. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or poison control center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Do not use with other products containing acetaminophen.
CAUTION: This product will cause drowsiness. Do not drive a motor vehicle or operate machinery after use.
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).
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.
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.
Caplets: Cellulose, Cornstarch, FD&C Blue #1, FD&C Blue #2, Hydroxypropyl Methylcellulose, Magnesium Stearate, Polyethylene Glycol, Polysorbate 80, Sodium Citrate, Sodium Starch Glycolate, Titanium Dioxide.
Geltabs/Gelcaps: Benzyl Alcohol, Butylparaben, Castor Oil, Cellulose, Corn Starch, D&C Red #28, Edetate Calcium Disodium, FD&C Blue #1, Gelatin, Hydroxypropyl Methylcellulose, Magnesium Stearate, Methylparaben, Propylparaben, Sodium Citrate, Sodium Lauryl Sulfate, Sodium Propionate, Sodium Starch Glycolate, Titanium Dioxide.
Caplets (colored light blue imprinted "Tylenol PM") vials of 10 and tamper-evident bottles of 24, 50, 100, and 150. Store at room temperature.
Gelcaps (colored blue and white imprinted "TYLENOL PM") tamper-evident bottles of 24 and 50. Store at room temperature; avoid high humidity and excessive heat 40°C (104°F).
Geltabs (colored blue and white imprinted "TYLENOL PM") tamper-evident bottles of 24, 50, and 100. Store at room temperature; avoid high humidity and excessive heat 40°C (104°F).
|
|