Extra Strength Tylenol PM Caplets, Geltabs, Gelcaps and Liquid (McNeil Consumer)

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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)

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.

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