TYLENOL® PM Extra Strength

Pain Reliever/Sleep Aid Caplets and Geltabs

TYLENOL® PM Extra Strength

Use only as directed.

This website contains the most current Drug Facts labeling information, and may differ from labels on product packaging you may have. If there are any differences between this website labeling and product packaging labeling, this website labeling should be regarded as the most current.

Availability Update

Your patients may have noticed that some Adult TYLENOL® products have been hard to find in stores. We sincerely apologize for any difficulty this may be causing you and your patients.

At present, TYLENOL® Arthritis Pain and TYLENOL® PM Extra Strength are not available in stores. We will provide updates as these products become available. If you have further questions, please call our Medical Communications Center at 1-866-948-6883 from Monday through Friday, 9:00 am to 4:30 pm ET.

TYLENOL® PM Extra Strength

Use only as directed.

Description/Ingredients

Each TYLENOL® PM Extra Strength Caplet and Geltab contains acetaminophen 500 mg and diphenhydramine HCl 25 mg.

TYLENOL® PM Extra Strength

Use only as directed.

Mechanism of Action

TYLENOL® PM Extra Strength Caplets and Geltabs contain a clinically proven analgesic-antipyretic and an antihistamine. The combination of acetaminophen and diphenhydramine provides temporary relief of occasional headaches and minor aches and pains with 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 is thought to produce analgesia by elevation of the pain threshold. Diphenhydramine HCl is an antihistamine with sedative properties.

TYLENOL® PM Extra Strength

Use only as directed.

Uses

TYLENOL® PM Extra Strength:

  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
TYLENOL® PM Extra Strength

Use only as directed.

Dosage Information

TYLENOL® PM Extra Strength Caplets and Geltabs:

Adults and children 12 years and over

  • take 2 caplets or geltabs at bedtime
  • do not take more than 2 caplets or geltabs of this product in 24 hours

Children under 12 years

  • do not use
TYLENOL® PM Extra Strength

Use only as directed.

Warnings

TYLENOL® PM Extra Strength

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

 

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

 

Other Information:

TYLENOL® PM Extra Strength Caplets

  • store between 20-25ºC (68-77ºF)

TYLENOL® PM Extra Strength Geltabs

  • store between 20-25ºC (68-77ºF). Avoid high humidity
TYLENOL® PM Extra Strength

Use only as directed.

PROFESSIONAL INFORMATION: OVERDOSAGE INFORMATION

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 TYLENOL® combination products contain active ingredients in addition to acetaminophen. The following is basic overdose information regarding those ingredients.

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.

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.

TYLENOL® PM Extra Strength

Use only as directed.

How Supplied

TYLENOL® PM Extra Strength Caplets

TYLENOL® PM Extra Strength Caplets

Geltabs

TYLENOL® PM Extra Strength Geltabs

 

NOTE:These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

TYLENOL® PM Extra Strength

Use only as directed.

Inactive Ingredients

TYLENOL® PM Extra Strength Caplets: carnauba wax, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium citrate, sodium starch glycolate, titanium dioxide

TYLENOL® PM Extra Strength Geltabs: benzyl alcohol, butylparaben, castor oil, D&C red no. 28, edetate calcium disodium, FD&C blue no. 1, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, shellac, simethicone, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide