DESCRIPTION

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

ACTIONS

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.

USES

For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

DIRECTIONS

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.

PRECAUTIONS

If a rare sensitivity reaction occurs, the drug should be discontinued.

WARNINGS

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.

Professional Information:

Overdosage Information

For overdosage information, please refer to pgs. __ - __.

INACTIVE INGREDIENTS

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.

HOW SUPPLIED

Caplets (colored light blue imprinted "Tylenol PM") 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).

PRODUCT PHOTO(S):

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

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.

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