Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mgDiphenhydramine HCl 25 mg

Purpose

Acetaminophen 500 mg...............................................................Pain relieverDiphenhydramine HCl 25 mg ...............................................Nighttime sleep-aid

INDICATIONS & USAGE SECTION

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

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

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

• more than 4,000 mg of acetaminophen in 24 hours
• 3 or more alcoholic drinks every day while using this product
• with other drugs containing acetaminophen

Do not use

• with any other product containing diphenhydramine, even one used on skin
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• liver disease
• difficulty in urination due to 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

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

Stop use and ask a doctor if

These could be signs of a serious condition.

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 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

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25°C (77°F); 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 #2 aluminum lake, FD&C Red #40 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide