DESCRIPTION

Each Extra Strength TYLENOL® PM Caplet, Geltab or Gelcap contains acetaminophen 500 mg and diphenhydramine HCl 25 mg. Each 30 mL = 2 Tablespoonfuls of TYLENOL® PM Liquid contains acetaminophen 1000 mg and diphenhydramine HCl 50 mg.

ACTIONS

Extra Strength TYLENOL® PM Caplets , Geltabs, Gelcaps, and Liquid 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 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 produces analgesia by elevation of the pain threshold. Diphenhydramine HCl is an antihistamine with sedative properties.

USES

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

DIRECTIONS

do not take more than directed (see overdose warning)

*Extra Strength TYLENOL® PM Caplets, Geltabs and Gelcaps:*
adults and children 12 years and over	·take 2 caplets, geltabs or gelcaps at bedtime or as directed by a doctor
children under 12 years	·do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

*Extra Strength TYLENOL® PM Liquid*
adults and children 12 years and over	·take 2 tablespoons (tbsp.) or 30 mL in dose cup provided at bedtime or as directed by a doctor. ·do not take more than 8 tablespoons in 24 hours
children under 12 years	·do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

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

with any other product containing acetaminophen
with any other product containing diphenhydramine, even one used on skin.
in children under 12 years of age

Ask a doctor before use if you have

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 sedatives or tranquilizers.

When using this product

drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery
alcohol, sedatives and tranquilizers may increase drowsiness (Extra Strength TYLENOL® PM Liquid)

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.
new symptoms occur
redness or swelling is present
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days

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

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

Carton: do not use if carton is opened or neck wrap or foil inner seal imprinted with "Safety Seal®" is broken
Label: do not use if neck wrap or foil inner seal imprinted with "Safety Seal" is broken or missing
Pouch: do not use if pouch is opened
store between 20-25°C (68-77°F).
Store at room temperature; avoid high humidity and excessive heat 40°C (104°F). (Applies only to Tylenol® PM Geltabs/Gelcaps)
see end panel for lot number and expiration date
see back label for lot number and expiration date (Applies only to TYLENOL® PM Liquid)

PROFESSIONAL INFORMATION :
OVERDOSAGE INFORMATION

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

Inactive Ingredients:

Caplets: carnauba wax, cellulose, corn starch, FD&C Blue #1, FD&C Blue #2, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium citrate, sodium starch glycolate, titanium dioxide.

Vanilla Caplets: carnauba wax, cellulose, corn starch, FD&C blue #1, FD&C blue #2, flavor, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium citrate, sodium starch glycolate, sucralose titanium dioxide, yellow iron oxide.

Geltabs/Gelcaps: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, D&C Red #28, edetate calcium disodium, FD&C Blue #1, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, propylparaben, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.

Liquid: caramel color, citric acid, FD&C red #40, flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol, sucralose, sucrose.

HOW SUPPLIED

Caplets (colored light blue imprinted "Tylenol PM") tamper evident bottles of 24, 50, 100, and 150 and 225.

Vanilla Caplets (colored off white and blue imprinted "TYLENOL PM") tamper evident bottles of 6, 24 and 100.

Gelcaps (colored blue and white imprinted "TYLENOL PM") tamper-evident bottles of 24 and 50.

Geltabs (colored blue and white imprinted "TYLENOL PM") tamper-evident bottles of 24, 50, and 100 and 150.

Liquid (brown colored vanilla liquid) Bottles of 1 oz and 8 fl. oz.

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's identity should be verified by chemical analysis.