Drug Facts

Active ingredients (in each caplet) Purpose

Acetaminophen 500 mg..............................…………………...Pain reliever

Diphenhydramine citrate 38 mg…….…………………..Nighttime sleep-aid

Use for relief of occasional sleeplessness when associated with minor aches and pains from premenstrual and menstrual periods (dysmenorrhea).

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 or severe allergic reactions. Symptoms may include:

· skin reddening · blisters · rash

· hives · facial swelling · asthma (wheezing)

· shock

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

Do not 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.

· in children under 12 years of age

· with any other product containing diphenhydramine, even one used

on skin

· 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

· glaucoma

· 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

· 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 serious underlying medical illness.

· pain gets worse or lasts more than 10 days

· fever gets worse or lasts more than 3 days

· new symptoms occur

· redness or swelling is present

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

Keep out of reach of children. 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.

Directions

Directions

· do not take more than the recommended dose

· adults and children 12 years and older: take 2 caplets at bedtime if needed, or as directed by a doctor

· children under 12 years: do not use

Other information store at room temperature

Inactive ingredients

Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, povidone, propylene glycol, shellac, stearic acid, titanium dioxide

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)