FDA Label for Acetaminophen Extra Strength Pm

Active Ingredients (In Each Caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

Uses

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

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

• with any other product containing diphenhydramine, even one used on skin

• in children under 12 years of age

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

• if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

• a breathing problem such as emphysema or chronic bronchitis

• liver disease

• glaucoma

• difficulty in urination due to an enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers

When Using This Product

• avoid alcoholic beverages

• drowsiness will occur

• 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 a serious underlying medical illness.

• new symptoms occur

• redness or swelling is present

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

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.

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

Directions

• do not take more than directed
• adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
• children under 12 years: do not use

Other Information

• store at 25°C (77°); excursions permitted between 15°-30°C (59°-86°F)

• see end flap for expiration date and lot number

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN EXTRA STRENGTH TYLENOL® PM*

Acetaminophen  EXTRA STRENGTH

Acetaminophen, 500 mg
Diphenhydramine HCl, 25 mg                         PM

PAIN RELIEVER/NIGHTTIME SLEEP AID

•Non Aspirin

BEING WELL®

50 CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® PM.

50844    REV0417E23515

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