Non-Aspirin PM Extra Strength

New World Imports, Inc

Extra Strength Pain Relief PM

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Non-Aspirin PM Extra Strength 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
• Directions
• Non-Aspirin PM Extra Strength Other information
• Inactive ingredients
• Product Labeling

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep aid

Non-Aspirin PM Extra Strength Uses

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

Warnings

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 maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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
• difficulty in urinating due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

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

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• pain gets worse or lasts 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.

Directions

• 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.

Non-Aspirin PM Extra Strength Other information

• store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
• do not use if imprinted safety seal under cap is broken or missing
• **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered
  trademark Tylenol® PM
  

Inactive ingredients

Product Labeling

SEE NEW WARNINGS INFORMATION

Non-Aspirin PM Extra Strength

Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

Pain reliever /
Nighttime Sleep-Aid

50 CAPLETS

You may report serious side effects to:
Distributed by NWI, Inc.
160 Athens Way
Nashville, TN 37228