pain reliever pm

McKesson (Sunmark)
P and L Development of New York Corporation

Extra Strength Acetaminophen PM

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• Active ingredients (in each caplet)
• Purpose
• pain reliever pm Uses
• Warnings
  • 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
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children
• Directions
• pain reliever pm Other information
• Inactive ingredients
• Questions or Comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

DRUG FACTS

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep- aid

pain reliever pm 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

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

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

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

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)

pain reliever pm Other information

• store at room temperature 15°-30°C (59°-86°F)
• avoid high humidity and excessive heat

Inactive ingredients

croscarmellose sodium*, D and C Yellow #10 Aluminum Lake*, FD and C Blue #1 Aluminum Lake, FD and C Blue #2 Aluminum Lake*, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, titanium dioxide, triacetin*

*contains one or more of these ingredients

Questions or Comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to EXTRA STRENTH Tylenol® PM active ingredients **

Pain Reliever PM

Extra Strength

Pain reliever /nighttime Sleep-Aid

Non- habit forming

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM.