Pain reliever PM

P and L Development of New York Corporation

DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*

• 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
• Product Label

FULL PRESCRIBING INFORMATION

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 accompanying sleeplessness

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 2 caplets in 24 hours, which is maximum daily amount 
• 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 other products 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
• 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 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

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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)

Other information

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

Inactive ingredients

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

*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

**Compare to the active ingredients in TYLENOL® PM

Pain Reliever PM

extra strength

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

Pain reliever/ Nighttime Sleep Aid

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

PL Developments

Westbury, NY 11590

Product Label