Drug Facts

Active Ingredients

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

Pain reliever

Nightime sleep aid

Keep Out of reach of Children

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.  Quick Medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Uses

Temporarily relieves 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 4000 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 sever 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:

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

•drowsiness will occur

•do not drive a motor vehicle or operate machinery

•avoid alcoholic drinks

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

•pain gets worse or last for more than 10 days.

•fever gets worse or last for more than 3 days

•redness or swelling are present

•new symptoms occur.  These could be signs of a serious condition.

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

• with any 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 even had an allergic reaction to this product or any of its ingredients

Directions

Do not use more than directed.  (see overdose warning)

Adults and children 12 years of age and older: Take 2 caplets at bedtime.  Do not take more than 2 caplets in 24 hours

Children under 12 years: do not use

Inactive Ingredients

Croscarmellose sodium, FD and C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide, Copovidone K25-31, Lactose, and Magnesium Sterate