FDA Label for Pain Relief Pm

Active Ingredients (In Each Caplet)

Acetaminophen 500 mg

Diphenhydramine 25 mg

Purpose

Acetaminophen 500 mg ....................................................................................................................................Pain reliever
Diphenhydramine HCl 25 mg ...........................................................................….................................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 hrs ■ 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 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 ever had an allergic reaction to this product or any of its ingredients.

Ask A Doctor Before Use If You Have:

■ liver disease

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged 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

■ 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.

Directions:

■ do not take more than directed (see overdose warning) adults and children 12 years and over
■ take 2 caplets at bedtime

■ do not take more than 2 caplets in 24 hours unless directed by a doctor

■ children under 12 years do not use

Other Information:

• store at 20°-25°C (68°-77°F)

Inactive Ingredients:

FD & C Blue # 1, FD & C Blue # 2, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene glycol 400, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Titanium Dioxide.

Questions Or Comments?

Call 1-718-337-8733 or visit [email protected]