ADVIL PM

Pfizer Consumer Healthcare

Advil PM (diphenhydramine citrate and ibuprofen)

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• ACTIVE INGREDIENTS (IN EACH CAPLET)
• PURPOSES
• USES
• WARNINGS
  • Allergy alert:
  • Stomach bleeding warning:
  • Do not use
  • Ask a doctor before use if
  • 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
• OTHER INFORMATION
• INACTIVE INGREDIENTS
• QUESTIONS OR COMMENTS?
• PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Label
• PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Carton
• PRINCIPAL DISPLAY PANEL - 4 Caplet Carton
• PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch
• PRINCIPAL DISPLAY PANEL - 50 Pouch Tray

FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH CAPLET)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSES

Nighttime sleep-aid

Pain reliever

USES

• for relief of occasional sleeplessness when associated with minor aches and pains
• helps you fall asleep and stay asleep

WARNINGS

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• unless you have time for a full night's sleep
• in children under 12 years of age
• right before or after heart surgery
• with any other product containing diphenhydramine, even one used on skin
• if you have sleeplessness without pain

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
• you are taking a diuretic
• you have a breathing problem such as emphysema or chronic bronchitis
• you have glaucoma
• you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers, or any other sleep-aid
• under a doctor’s care for any continuing medical illness
• taking any other antihistamines
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

When using this product

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• redness or swelling is present in the painful area
• any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• do not take more than directed
• adults and children 12 years and over: take 2 caplets at bedtime
• do not take more than 2 caplets in 24 hours

OTHER INFORMATION

• read all warnings and directions before use. Keep carton.
• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENTS

calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

QUESTIONS OR COMMENTS?

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

For most recent product information, visit www.Advil.com.

PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Label

Advil^®PM

Ibuprofen, 200 mg/Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/Nighttime Sleep-Aid

20 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Carton

Advil ^® PM

Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID) / Nighttime Sleep-Aid

20 Coated Caplets*
*Capsule-Shaped Tablets

Caplets

PRINCIPAL DISPLAY PANEL - 4 Caplet Carton

COUPON INSIDE

for next purchase
of 16ct or larger

Advil^®PM

Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID) / Nighttime Sleep-Aid

4 Coated Caplets*
*Capsule-Shaped Tablets

Caplets

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch

Advil^®PM

Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/Nighttime Sleep-Aid

2 Caplets

PRINCIPAL DISPLAY PANEL - 50 Pouch Tray

Advil^®PM

Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID) / Nighttime Sleep-Aid

Caplets

• For relief of occasional sleeplessness when
  associated with minor aches and pains
• Helps you fall asleep and stay asleep

50 PACKETS OF 2 COATED CAPLETS*
*Capsule-Shaped Tablets