Aspirin Free Headache PM

Greenbrier International, Inc.

Assured 44-373

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each tablet)
• Purpose
• Aspirin Free Headache PM Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Aspirin Free Headache PM Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Acetaminophen 500 mg
Diphenhydramine citrate 38 mg

Purpose

Pain reliever
Nighttime sleep-aid

Aspirin Free Headache PM Uses

for the 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 containin diphenhydramine, even one used on skin

• in children under 12 years of age

Ask a doctor before use if

• a breathing problem such as emphysema or chronic bronchitis

• liver disease

• trouble urinating due to an enlarged prostate gland

• glaucoma

Ask a doctor or pharmacist before use if

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

When using this product

• drowsiness may occur

• avoid alcoholic beverages

• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

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

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• new symptoms occur

• painful area is red or swollen

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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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)

• adults and children 12 years and over: take 2 tablets at bedtime. Do not take more than 2 tablets of this product in 24 hours.

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

Aspirin Free Headache PM Other information

• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

• see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED™

*COMPARE TO THE ACTIVE INGREDIENT IN EXCEDRIN® PM

Aspirin Free
HEADACHE PM
• Acetaminophen 500 mg - Pain Reliever
• Diphenhydramine citrate 38 mg - Nighttime Sleep-Aid

NON-HABIT FORMING
40 tablets

*This product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® PM.
50844    ORG071237310

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