Headache Relief PM

WALGREEN CO.

Walgreens 44-373

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each tablet)
• Purpose
• Headache Relief 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
• Headache Relief PM Other information
• Inactive ingredients
• Questions or comments?
• Product Packaging

FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Acetaminophen 500 mg
Diphenhydramine citrate 38 mg

Purpose

Pain reliever
Nighttime sleep-aid

Headache Relief 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 you have

• 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 you are

• 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 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.

Headache Relief 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

Product Packaging

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0373-12

Headache
Relief PM
Acetaminophen / Pain Reliever
Diphenhydramine Citrate / Nighttime Sleep Aid
• Aspirin free
• Non-habit forming

100 COATED TABLETS

NIGHTTIME

Compare to Excedrin® PM Tablets active ingredientsǂǂ

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
ǂWalgreens Pharmacist Survey Study, November 2010.
ǂǂThis product is not manufactured or distributed by Novartis Consumer Health, Inc, owner of the registered trademark Excedrin® PM Tablets.
50844    ORG071237312