PM Acetaminophen

New World Imports, Inc

Drug Facts

FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 500 mg

Diphenhydramine HCI 25 mg

Purpose

Acetaminophen - Pain Reliever

Diphenhydramine - Nighttime Sleep Aid

Keep out of reach of Children

Uses

Temporary relief of occasional headaches, minor aches, and pains accompanying sleeplessness

Liver Warning:This product contains acetaminophen.  Severe liver damage may occur with this product if you take:

More than 2 caplets in 24 hours, which is the daily maximum amount

With other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Overdose warning: Taking more than the recommended done (overdose) may cause liver damage. In case of 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 children even if you do not notice any signs or symptoms.

Do not use:

With other products 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 other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have: liver disease, asthma, breathing problems such as emphysema or chronic bronchitis, glaucoma, or difficulty in urinating due to an enlargement of the prostate gland.

Ask a doctor or pharmacist before use if you are: taking sedatives or tranquilzers, or taking the blood thinning drug warfin

When using this product: Avoid alcoholic beverages, do not drive a motor vehicle or operate machinery.  This product will cause drowsiness.

Stop use and ask a doctor if:

Sleepiness persists continuously for more than 2 weeks.  Insomnia may be a symptom of a serious underlying medical illness.

Pain gets worse or last for more than 10 days

Fever gets worse or lasts for more than 3 days

New symptoms occur

Redness or swelling is present

If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children.

Do not exceed recommended dose

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

Children under 12 years of age:Do not use this product in children under 12 years of age.  This will provide more than the recommended dose (overdose) and may cause liver damage.

FD and C Blue #1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyvinyl alcohol, polyvinylpyrrolidone, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide.