FDA Label for Pain Reliever And Sleep Aid

Drug Facts

Active Ingredient (In Each Tablet)

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

• liver disease • 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 If You Are

• taking the blood thinning drug warfarin • taking sedatives or tranquilizers

When Using This Product

• drowsiness will occur • avoid alcoholic drinks • 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 • pain gets worse or lasts for more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur
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.

Overdose Warning:

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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 (see overdose warning)

Other Information

• store between 20–25°C (68–77°F)

Inactive Ingredients

FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

1-888-333-9792

Distributed By:

Cabinet Health P.B.C.